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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1238-9163 | Registry Identifier | WHO |
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Study was terminated early due to futility.
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This study has 2 phases.
The main aims of Phase 1b are:
The main aims of Phase 2 are:
Participants will receive modakafusp alfa for up to 1 year (Phase 1b) or modakafusp alfa given together with pembrolizumab for up to 2 years (Phase 2). Those whose symptoms improve might continue treatment for longer.
In both phases of the study, participants will revisit the study clinic within 30 days after their last dose or before they start other cancer treatment, whichever happens first.
The drug being tested in this study is called modakafusp alfa (TAK-573). Modakafusp alfa is being tested to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity as single agent (SA) or in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors. The study will consist of 2 phases: Phase 1b dose escalation and a Phase 2 dose expansion.
The study will enroll approximately 114 participants (approximately 30 participants in Phase 1b dose escalation phase; 3-9 participants in safety-lead in and 25 participants for each expansion cohort (3 cohorts) of Phase 2.
The dose escalation phase will enroll participants with solid tumors. The dose escalation phase is to evaluate SA recommended phase 2 dose (RP2D).
The dose expansion phase in combination with pembrolizumab will be initiated with a safety lead-in phase once the SA RP2D is determined for modakafusp alfa. The dose expansion will include participants with one of following 3 disease indications:
I. Unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-disease programmed cell death protein 1 (PD1) containing treatments in the metastatic setting.
II. Unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
III. Unresectable/metastatic cutaneous melanoma naïve to prior anti-PD1 containing treatments in the metastatic setting.
This multi-center trial will be conducted in the United States and Australia. Participants with demonstrated clinical benefit may continue treatment beyond 1 year for Phase 1b and 2 years for Phase 2 if approved by the sponsor. The overall time to participate in this study is 55 months. All participants will make an end of treatment (EOT) visit 30 days after receiving their last dose of study drug or before the start of subsequent systemic anticancer therapy, whichever occurs first for a safety follow up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b SA Dose Escalation | Experimental | Modakafusp alfa 0.1 to 6 milligram per kilogram (mg/kg), infusion, intravenously, once on Day 1 of each 21-days treatment cycle for up to 1 year. |
|
| Phase 2 Safety Lead-in Dose Expansion: Modakafusp Alfa + Pembrolizumab | Experimental | Melanoma with primary resistance to prior anti-PD1, acquired resistance to prior anti-PD1 or naïve to anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years. The starting dose of modakafusp alfa for dose expansion safety lead-in phase will be the RP2D determined in the previous Phase 1b dose escalation phase. |
|
| Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma With Primary Resistance) | Experimental | Melanoma With Primary Resistance to prior anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety-lead in phase. |
|
| Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma With Acquired Resistance) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modakafusp Alfa | Drug | Modakafusp alfa intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | From signing of the informed consent form (ICF) through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) |
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs | TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) |
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Dose Limiting Toxicities (DLTs) | A DLT was defined as any of the following AEs that occurred in the escalation phase or in the combination safety lead-in phase during Cycle 1 unless they were considered by the investigator to be clearly unrelated to therapy with modakafusp alfa according to NCI CTCAE version 5.0. Any Grade 5 TEAE. Febrile neutropenia: Grade >=3 or 4 neutropenia. Grade 4 thrombocytopenia. Grade >=3 thrombocytopenia. Any Grade 3 immune-related AEs such as pericarditis, pneumonitis, cardiotoxicity, hepatitis, or neurotoxicity. Delay in the initiation of Cycle 2 by more than 14 days from the calculated start date due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities. Any Grade >=3 nonhematologic toxicity with some exception. Any Grade 2 nonhematologic toxicity that was considered by the investigator to be related to study drug and dose-limiting. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Maximum Tolerated Dose (MTD) of Modakafusp Alfa | The MTD was selected as the highest dose which has maximum probability of being in targeted toxicity interval. | Cycle 1 (Cycle length = 21 days) |
| Phase 1b and Phase 2 Safety Lead-in: Recommended Phase 2 Dose (RP2D) for Single Agent (SA) Modakafusp Alfa in Phase 1b and in Combination With Pembrolizumab in Phase 2 Safety Lead-in |
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Inclusion Criteria:
Phase 2 Dose Expansion:
The combination cohorts, including participants in the safety-lead phase, will enroll participants with unresectable/metastatic melanoma in the following subgroups:
I. Unresectable/metastatic histologically confirmed cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
II. Unresectable/metastatic histologically confirmed cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
III. Unresectable/metastatic histologically confirmed cutaneous melanoma naive to prior anti-PD1 containing treatments in the metastatic setting.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center - Duarte | Duarte | California | 91010 | United States | ||
| University of California San Diego Moores Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41445795 | Derived | Gill D, Cowey CL, Daniels GA, Sommerhalder D, Abdul-Karim R, Kirkwood JM, Kolodney J, Mehmi I, Roberts-Thomson R, Strauss J, Thomas S, Whitman E, Xing Y, McKean M, Collins S, Li C, Saggu G, Chen T, Wang S, Lewis M, Parot X, Johnson M. A phase Ib/II study of modakafusp alfa alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors. Front Oncol. 2025 Dec 8;15:1620987. doi: 10.3389/fonc.2025.1620987. eCollection 2025. |
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Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit USMedInfo@tevapharm.com to make your request.
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Participants were enrolled to Phase 1b (Dose Escalation) to receive single agent modakafusp alfa, and combination therapy of modakafusp alfa and pembrolizumab in Phase 2 (Safety lead-in, and Expansion with 3 Cohorts [Cohorts I, II and III). Cohort III had no enrolment due to strategic reason, therefore, no data was collected and reported for Cohort III in this report.](streamdown:incomplete-link)
Participants took part in the study at 17 investigative sites in the United States and Australia from 12 December 2019 to 20 December 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.1 milligrams per kilogram (mg/kg), infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| FG001 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2022 | Nov 4, 2024 |
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| Experimental |
Melanoma With Acquired Resistance to prior anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety lead-in phase. |
|
| Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma naïve to anti-PD1) | Experimental | Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma naive to prior line of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety lead-in phase. |
|
|
| Pembrolizumab | Drug | Pembrolizumab intravenous infusion. |
|
| Cycle 1 (Cycle length is equal to [=] 21 days) |
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Serious Adverse Event (SAEs) | SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent. | From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) |
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) |
| Phase 2 Expansion: Overall Response Rate (ORR) Based on RECIST v1.1 | ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From the first dose of study drug up to end of treatment or end of study (up to 2 years) |
The RP2D of modakafusp alfa as a single agent or in combination with pembrolizumab was determined based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v5.0. |
| Cycle 1 (Cycle length = 21 days) |
| Phase 2 Expansion: Number of Participants Reporting One or More TEAEs | AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) |
| Phase 2 Expansion: Number of Participants With Grade 3 or Higher TEAEs | TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) |
| Phase 2 Expansion: Number of Participants Reporting One or More SAEs | SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent. | From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 2 years 1 month) |
| Phase 2 Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) |
| Phase 1b and Phase 2 Safety Lead-in: Maximum Observed Serum Concentration (Cmax) for Modakafusp Alfa | Cmax for modakafusp alfa was reported. | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
| Phase 1b and Phase 2 Safety Lead-in: Time to Reach the Cmax (Tmax) for Modakafusp Alfa | Tmax for modakafusp alfa was reported. | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
| Phase 1b and Phase 2 Safety Lead-in: Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) for Modakafusp Alfa | AUClast for modakafusp alfa was reported. | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
| Phase 1b and Phase 2 Safety Lead-in: Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Modakafusp Alfa | AUCinf of modakafusp alfa was reported. | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
| Phase 1b and Phase 2 Safety Lead-in: Terminal Disposition Phase Half-life (t1/2z) for Modakafusp Alfa | T1/2z of modakafusp alfa was reported. | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
| Phase 1b and Phase 2 Safety Lead-in: Total Clearance (CL) After Intravenous Administration for Modakafusp Alfa | CL was total clearance of the drug from the serum. CL of modakafusp alfa was reported. | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
| Phase 1b and Phase 2 Safety Lead-in: Volume of Distribution at Steady State (Vss) for Modakafusp Alfa | Vss of modakafusp alfa was reported. | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
| Phase 1b and Phase 2 Safety Lead-in: ORR Based on RECIST v1.1 | ORR was defined as the percentage of participants who achieved CR or PR as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From the first dose of study drug up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2) |
| Phase 1b and Phase 2: Disease Control Rate (DCR) Based on RECIST v1.1 | DCR was defined as the percentage of participants who achieved CR, PR, or stable disease (SD) (determined by the investigator) as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD), taking as reference the smallest sum diameters while on study. | From the first dose of study drug up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2) |
| Phase 1b and Phase 2: Duration of Response (DOR) Based on RECIST v1.1 | DOR was defined as the time from the first documentation of a response (CR or PR) until PD or death, whichever occurred first as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | From the date of first documentation of a CR or PR until PD or death, whichever occurred first (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2]) |
| Phase 1b and Phase 2: Time to Progression (TTP) Based on RECIST v1.1 | TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD according to RECIST v1.1. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | From the date of the first dose of study drug to the date of the first documentation of PD (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2]) |
| Phase 1b and Phase 2: Progression Free Survival (PFS) Based on RECIST v1.1 | PFS was defined as the time from the date of the first dose of study drug to the date of first documentation of PD according to RECIST v.1.1, or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | From the date of the first dose of study drug to the date of first documentation of PD or death, whichever occurred first (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2]) |
| Phase 1b and Phase 2: Overall Survival (OS) Based on RECIST v1.1 | OS was defined as the time from the date of first dose of study drug to the date of death due to any cause. | From the date of first dose of study drug to the date of death due to any cause (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2]) |
| Phase 2 Expansion: ORR Based on Based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST) | ORR was defined as the percentage of participants whose BOR was immune CR (iCR) or immune PR (iPR), according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions immune confirmed progressive disease (iCPD). (iCPD): immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. iSD: immune stable disease in the absence of iCR or immune PD (iPD). iUPD: immune unconfirmed progressive disease (iUPD) when iCPD is unconfirmed NE: not evaluable. | From date of first dose of study drug until confirmed iCR or iPR (up to end of treatment or end of study [up to 2 years]) |
| Phase 2 Expansion: DCR Based on iRECIST | DCR was defined as percentage of participants who have achieved the best response of iCR, iPR, iSD based on iRECIST as per investigator assessment. iCR: achieved with disappearance of all target lesions, iPR: achieved with disappearance of partial target lesions. iSD: in the absence of iCR or iCPD. iUPD: when iPD is unconfirmed NE: not evaluable. | From date of first dose of study drug until confirmed iCR or iPR (up to end of treatment or end of study [up to 2 years]) |
| Phase 2 Expansion: DOR Based on iRECIST | DOR was defined as time from date of first observation of response (iPR or iCR) to date of the first observation of progression (iCPD) based on iRECIST as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | From first documented confirmed iCR or iPR until first documentation of iCPD or death (up to end of treatment or end of study [up to 2 years]) |
| Phase 2 Expansion: TTP Based on iRECIST | TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of iCPD based on iRECIST as per investigator assessment. iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | From the date of the first dose of study drug to the date of the first documentation of iCPD (up to end of treatment or end of study [up to 2 years]) |
| Phase 2 Expansion: PFS Based on iRECIST | PFS was defined as the time from the first dose date to the date of iCPD or date of death (whichever occurred first) based on iRECIST as per investigator assessment. iCPD was defined as immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | From first dose of study drug until confirmed iCPD or death (up to end of treatment or end of study [up to 2 years]) |
| Phase 1b and Phase 2: Number of Participants With Positive Anti-Modakafusp Alfa Antibodies (ADA) Status | ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive. | Baseline up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2) |
| Phase 1b and Phase 2: Titer of Anti-Modakafusp Alfa Antibodies (ADA) | ADA titers were assessed by confirmatory assay. | Baseline up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2) |
| La Jolla |
| California |
| 92093 |
| United States |
| The Angeles Clinic and Research Institute - West Los Angeles Office | Los Angeles | California | 90025 | United States |
| University of Colorado Health Memorial Hospital Central | Colorado Springs | Colorado | 80909 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | United States |
| Norris Cotton Cancer Center Lebanon | Lebanon | New Hampshire | 03756 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| West Virginia University Health Sciences Campus | Morgantown | West Virginia | 26506 | United States |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Ballarat Regional Integrated Cancer Center | Ballarat | Victoria | 3350 | Australia |
Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| FG002 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| FG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| FG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| FG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| FG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| FG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| FG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| FG009 | Phase 2, Expansion, Cohort III: Modakafusp Alfa + Pembrolizumab | Participants with unresectable/metastatic cutaneous melanoma naïve to prior line of anti-PD1 containing treatments in the metastatic setting were planned to receive modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.1 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| BG001 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| BG002 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| BG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| BG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| BG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| BG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| BG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| BG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
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| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Count of Participants | Participants | From signing of the informed consent form (ICF) through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) |
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| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs | TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Count of Participants | Participants | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) |
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| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Dose Limiting Toxicities (DLTs) | A DLT was defined as any of the following AEs that occurred in the escalation phase or in the combination safety lead-in phase during Cycle 1 unless they were considered by the investigator to be clearly unrelated to therapy with modakafusp alfa according to NCI CTCAE version 5.0. Any Grade 5 TEAE. Febrile neutropenia: Grade >=3 or 4 neutropenia. Grade 4 thrombocytopenia. Grade >=3 thrombocytopenia. Any Grade 3 immune-related AEs such as pericarditis, pneumonitis, cardiotoxicity, hepatitis, or neurotoxicity. Delay in the initiation of Cycle 2 by more than 14 days from the calculated start date due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities. Any Grade >=3 nonhematologic toxicity with some exception. Any Grade 2 nonhematologic toxicity that was considered by the investigator to be related to study drug and dose-limiting. | DLT evaluable analysis set included participants who received all Cycle 1 doses of modakafusp alfa or experience a DLT in Cycle 1 in the dose-escalation portion of the study; or participants who received all Cycle 1 doses of modakafusp alfa in combination with pembrolizumab or experience a DLT in Cycle 1 in the safety lead-in portion of the study. | Posted | Count of Participants | Participants | Cycle 1 (Cycle length is equal to [=] 21 days) |
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| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Serious Adverse Event (SAEs) | SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Count of Participants | Participants | From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) |
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| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Count of Participants | Participants | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) |
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| Primary | Phase 2 Expansion: Overall Response Rate (ORR) Based on RECIST v1.1 | ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study drug up to end of treatment or end of study (up to 2 years) |
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| Secondary | Phase 1b: Maximum Tolerated Dose (MTD) of Modakafusp Alfa | The MTD was selected as the highest dose which has maximum probability of being in targeted toxicity interval. | DLT evaluable analysis set included participants who received all Cycle 1 doses of modakafusp alfa or experience a DLT in Cycle 1 in the dose-escalation portion of the study. | Posted | Number | milligrams per kilograms (mg/kg) | Cycle 1 (Cycle length = 21 days) |
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| Secondary | Phase 1b and Phase 2 Safety Lead-in: Recommended Phase 2 Dose (RP2D) for Single Agent (SA) Modakafusp Alfa in Phase 1b and in Combination With Pembrolizumab in Phase 2 Safety Lead-in | The RP2D of modakafusp alfa as a single agent or in combination with pembrolizumab was determined based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v5.0. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Number | mg/kg | Cycle 1 (Cycle length = 21 days) |
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| Secondary | Phase 2 Expansion: Number of Participants Reporting One or More TEAEs | AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Count of Participants | Participants | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) |
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| Secondary | Phase 2 Expansion: Number of Participants With Grade 3 or Higher TEAEs | TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Count of Participants | Participants | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) |
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| Secondary | Phase 2 Expansion: Number of Participants Reporting One or More SAEs | SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Count of Participants | Participants | From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 2 years 1 month) |
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| Secondary | Phase 2 Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Count of Participants | Participants | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) |
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| Secondary | Phase 1b and Phase 2 Safety Lead-in: Maximum Observed Serum Concentration (Cmax) for Modakafusp Alfa | Cmax for modakafusp alfa was reported. | Pharmacokinetic (PK) analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "number analyzed" signified participants who were evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
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| Secondary | Phase 1b and Phase 2 Safety Lead-in: Time to Reach the Cmax (Tmax) for Modakafusp Alfa | Tmax for modakafusp alfa was reported. | PK analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable at specified timepoints. | Posted | Median | Full Range | hour | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
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| Secondary | Phase 1b and Phase 2 Safety Lead-in: Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) for Modakafusp Alfa | AUClast for modakafusp alfa was reported. | PK analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "number analyzed" signified participants who were evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
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| Secondary | Phase 1b and Phase 2 Safety Lead-in: Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Modakafusp Alfa | AUCinf of modakafusp alfa was reported. | PK analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
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| Secondary | Phase 1b and Phase 2 Safety Lead-in: Terminal Disposition Phase Half-life (t1/2z) for Modakafusp Alfa | T1/2z of modakafusp alfa was reported. | PK analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
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| Secondary | Phase 1b and Phase 2 Safety Lead-in: Total Clearance (CL) After Intravenous Administration for Modakafusp Alfa | CL was total clearance of the drug from the serum. CL of modakafusp alfa was reported. | PK analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per hour per kilograms (L/h/kg) | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
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| Secondary | Phase 1b and Phase 2 Safety Lead-in: Volume of Distribution at Steady State (Vss) for Modakafusp Alfa | Vss of modakafusp alfa was reported. | PK analysis set included participants who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. As planned, PK data at Cycles 1 and 2 Day 1 for Phase 1b, and Cycles 1 and 3 Day 1 for Phase 2 (Safety lead-in) was reported. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable at specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per kilograms (L/kg) | Phase 1b, Cycles 1 and 2 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion; Phase 2, Safety lead-in, Cycles 1 and 3 Day 1: Pre-infusion and at multiple timepoints (up to 72 hours) post-infusion (each cycle length=21 days) |
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| Secondary | Phase 1b and Phase 2 Safety Lead-in: ORR Based on RECIST v1.1 | ORR was defined as the percentage of participants who achieved CR or PR as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study drug up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2) |
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| Secondary | Phase 1b and Phase 2: Disease Control Rate (DCR) Based on RECIST v1.1 | DCR was defined as the percentage of participants who achieved CR, PR, or stable disease (SD) (determined by the investigator) as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD), taking as reference the smallest sum diameters while on study. | The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study drug up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2) |
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| Secondary | Phase 1b and Phase 2: Duration of Response (DOR) Based on RECIST v1.1 | DOR was defined as the time from the first documentation of a response (CR or PR) until PD or death, whichever occurred first as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Here, "overall number of participants analyzed" signified participants who had CR or PR. | Posted | Median | 95% Confidence Interval | months | From the date of first documentation of a CR or PR until PD or death, whichever occurred first (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2]) |
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| Secondary | Phase 1b and Phase 2: Time to Progression (TTP) Based on RECIST v1.1 | TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD according to RECIST v1.1. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Median | 95% Confidence Interval | months | From the date of the first dose of study drug to the date of the first documentation of PD (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2]) |
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| Secondary | Phase 1b and Phase 2: Progression Free Survival (PFS) Based on RECIST v1.1 | PFS was defined as the time from the date of the first dose of study drug to the date of first documentation of PD according to RECIST v.1.1, or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Median | 95% Confidence Interval | months | From the date of the first dose of study drug to the date of first documentation of PD or death, whichever occurred first (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2]) |
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| Secondary | Phase 1b and Phase 2: Overall Survival (OS) Based on RECIST v1.1 | OS was defined as the time from the date of first dose of study drug to the date of death due to any cause. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Median | 95% Confidence Interval | months | From the date of first dose of study drug to the date of death due to any cause (up to end of treatment or end of study [1 year for Phase 1b and 2 years for Phase 2]) |
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| Secondary | Phase 2 Expansion: ORR Based on Based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST) | ORR was defined as the percentage of participants whose BOR was immune CR (iCR) or immune PR (iPR), according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions immune confirmed progressive disease (iCPD). (iCPD): immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. iSD: immune stable disease in the absence of iCR or immune PD (iPD). iUPD: immune unconfirmed progressive disease (iUPD) when iCPD is unconfirmed NE: not evaluable. | The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of first dose of study drug until confirmed iCR or iPR (up to end of treatment or end of study [up to 2 years]) |
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| Secondary | Phase 2 Expansion: DCR Based on iRECIST | DCR was defined as percentage of participants who have achieved the best response of iCR, iPR, iSD based on iRECIST as per investigator assessment. iCR: achieved with disappearance of all target lesions, iPR: achieved with disappearance of partial target lesions. iSD: in the absence of iCR or iCPD. iUPD: when iPD is unconfirmed NE: not evaluable. | The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of first dose of study drug until confirmed iCR or iPR (up to end of treatment or end of study [up to 2 years]) |
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| Secondary | Phase 2 Expansion: DOR Based on iRECIST | DOR was defined as time from date of first observation of response (iPR or iCR) to date of the first observation of progression (iCPD) based on iRECIST as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Here, "overall number of participants analyzed" signifies participants who had iCR or iPR. | Posted | Median | 95% Confidence Interval | months | From first documented confirmed iCR or iPR until first documentation of iCPD or death (up to end of treatment or end of study [up to 2 years]) |
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| Secondary | Phase 2 Expansion: TTP Based on iRECIST | TTP was defined as the time from the date of the first dose of study drug to the date of the first documentation of iCPD based on iRECIST as per investigator assessment. iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Median | 95% Confidence Interval | months | From the date of the first dose of study drug to the date of the first documentation of iCPD (up to end of treatment or end of study [up to 2 years]) |
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| Secondary | Phase 2 Expansion: PFS Based on iRECIST | PFS was defined as the time from the first dose date to the date of iCPD or date of death (whichever occurred first) based on iRECIST as per investigator assessment. iCPD was defined as immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until confirmed iCPD or death (up to end of treatment or end of study [up to 2 years]) |
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| Secondary | Phase 1b and Phase 2: Number of Participants With Positive Anti-Modakafusp Alfa Antibodies (ADA) Status | ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive. | Immunogenicity-evaluable analysis set included participants with a baseline and at least one post-baseline immunogenicity assessment. | Posted | Count of Participants | Participants | Baseline up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1b and Phase 2: Titer of Anti-Modakafusp Alfa Antibodies (ADA) | ADA titers were assessed by confirmatory assay. | Immunogenicity-evaluable analysis set included participants with a baseline and at least one post-baseline immunogenicity assessment. | Posted | Median | Full Range | titers | Baseline up to end of treatment or end of study (up to 1 year for Phase 1b and 2 years for Phase 2) |
|
From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occured first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | Participants received modakafusp alfa 0.1mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. | 1 | 3 | 3 | 3 | 3 | 3 |
| EG001 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. | 2 | 3 | 1 | 3 | 2 | 3 |
| EG002 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. | 2 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. | 3 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. | 3 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. | 4 | 6 | 4 | 6 | 6 | 6 |
| EG006 | Phase 2, Safety Lead-in: Modakafusp Alfa + Pembrolizumab | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. | 1 | 3 | 0 | 3 | 3 | 3 |
| EG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa + Pembrolizumab | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. | 2 | 9 | 2 | 9 | 8 | 9 |
| EG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa + Pembrolizumab | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. | 4 | 12 | 6 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bell's palsy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood pressure fluctuation | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Brain fog | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intensive care unit delirium | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
Study was terminated early due to futility.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Teva Branded Pharmaceutical Products R&D LLC | 1-888-483-8279 | USMedInfo@tevapharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2021 | Nov 4, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 |
| Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg |
Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
|
|
| OG001 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG002 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
|
|
Participants with advanced/metastatic tumors received modakafusp alfa 0.2 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.
| OG002 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
|
|
Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle.
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| Participants |
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| Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg |
Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg |
Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| OG002 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| OG002 |
| Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg |
Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| OG002 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| OG002 |
| Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg |
Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| OG002 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| OG002 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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Participants with advanced/metastatic tumors received modakafusp alfa 0.4 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg |
Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| OG003 | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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| Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg |
Participants with advanced/metastatic tumors received modakafusp alfa 0.75 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG004 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG005 | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | Participants with advanced/metastatic tumors received modakafusp alfa 1.5 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle. |
| OG006 | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | Participants with any of the 3-melanoma disease of expansion Cohort I, II or III received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG007 | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti- programmed cell death protein 1 (PD1) containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
| OG008 | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | Participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting received modakafusp alfa 1.0 mg/kg, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once, every 6 weeks. |
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