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Sponsor decision
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This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity of FPT155 as monotherapy in patients with advanced solid tumors.
This Phase 1 study is comprised of dose escalation and cohort expansions for FPT155 monotherapy and for FPT155 in combination with pembrolizumab. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; combination dose escalation uses a standard 3+3 design. Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FPT155 monotherapy | Experimental | The study consists of dose escalation and cohort expansions |
|
| FPT155 in combination with pembrolizumab | Experimental | The study consists of dose escalation and cohort expansions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FPT155 | Biological | A soluble CD80 fusion protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAE was defined as an adverse event (AE) that was not present prior to the start date of study drug or was worsened during treatment and 100 days after last dose of treatment. An AE that was present at treatment initiation but resolved and then reappeared and the event severity increase while the participant was on treatment is also a TEAE. A severe AE (SAE) is defined as any untoward medical occurrence that at any dose: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, and is a congenital anomaly/birth defect. AEs were graded 1 (mild)-5 (fatal AE) according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03. | Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination |
| Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | DLTs ware defined as any of the events that occurred during the first 28 days of treatment and were assessed by the Clinical Research Coordinator (CRC) as related to FPT155. | Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days |
| Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs | Represents the number of participants who had discontinuation of FPT155 dosing due to AEs. | Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks. |
| Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs | Represents the number of participants who had a modification in the dosing schedules of FPT155 due to AEs. | Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 | |
| Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia | ||
| St Vincent's Hospital Sydney |
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Participants received escalating doses of FTP155 until the recommended dose (RD) was established in Phase 1a monotherapy. Phase 1b monotherapy involved dividing participants into 4 tumor-specific cohorts, treated at the RD. In Phase 1a combination therapy, participants with non-small cell lung cancer were split into 3 cohorts and given FTP155 below the RD with Pembrolizumab. Both Phase 1b monotherapy and Phase 1a combination were initiated but not completed due to the study's closure.
Participants with advanced solid tumours were recruited across 15 centers in Australia and South Korea from October 2018 to August 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1a Monotherapy: FPT155 Dose A | Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified. |
| FG001 | Phase 1a Monotherapy: FPT155 Dose B | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG002 | Phase 1a Monotherapy: FPT155 Dose C | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG003 | Phase 1a Monotherapy: FPT155 Dose D | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG004 | Phase 1a Monotherapy: FPT155 Dose E | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG005 | Phase 1a Monotherapy: FPT155 Dose F | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG006 | Phase 1a Monotherapy: FPT155 Dose G | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG007 | Phase 1a Monotherapy: FPT155 Dose H | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG008 | Phase 1a Monotherapy: FPT155 Dose I | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG009 | Phase 1a Monotherapy: FPT155 Dose J | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG010 | Phase 1a Monotherapy: FPT155 Dose K | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG011 | Phase 1a Monotherapy: FPT155 Dose L | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| FG012 | Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). |
| FG013 | Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). |
| FG014 | Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). |
| FG015 | Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K). |
| FG016 | Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab. |
| FG017 | Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab. |
| FG018 | Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: All participants who received any portion of a least one dose of FPT155.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1a Monotherapy: FPT155 Dose A | Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified. |
| BG001 | Phase 1a Monotherapy: FPT155 Dose B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAE was defined as an adverse event (AE) that was not present prior to the start date of study drug or was worsened during treatment and 100 days after last dose of treatment. An AE that was present at treatment initiation but resolved and then reappeared and the event severity increase while the participant was on treatment is also a TEAE. A severe AE (SAE) is defined as any untoward medical occurrence that at any dose: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, and is a congenital anomaly/birth defect. AEs were graded 1 (mild)-5 (fatal AE) according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03. | Safety population: All participants who received any portion of a least one dose of FPT155. | Posted | Count of Participants | Participants | Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination |
Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1a Monotherapy: FPT155 Dose A | Participants with advanced solid tumours received FPT155 IV Q3W in escalating doses (A-L) until the RD was identified. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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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 | Sep 14, 2020 | Oct 3, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2022 | Oct 3, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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Two arm trial with multiple cohorts
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| pembrolizumab | Biological | An anti-PD1 antibody |
|
| Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs | Represents the number of participants who had an interruption in the dosing schedules of FPT155 due to AEs. | Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks. |
| Phase 1a Combination: Number of Participants Who Experienced DLTs | DLTs ware defined as any of the events that occur during the first 28 days of treatment and are assessed by the CRC as related to FPT155. | Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days |
| Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1a Monotherapy: Clearance (CL) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment. | Cycle 1 (21-day cycles) Day 1 |
| Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1 | ORR was defined as the total number of participants with confirmed responses of either complete response (CR) (CR: The disappearance of all target lesions, any pathological lymph nodes [whether target or non-target] must have a reduction in short axis to <10 mm) or partial response (PR) (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1. | Up to approximately 30 months |
| Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1 | DOR was defined as the time from first response (CR [The disappearance of all target lesions, any pathological lymph nodes {whether target or non-target} or PR [At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters] determined by the investigator per RECIST v1.1) that was subsequently confirmed until the onset of progressive disease (DP) (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study [this includes the baseline sum if that is the smallest on study]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) or death from any cause, whichever occurred first.](streamdown:incomplete-link) | Up to approximately 30 months |
| Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1 | PFS was defined as time from the first dose of study treatment until the first documentation by the investigator of DP (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study [this includes the baseline sum if that is the smallest on study]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) per RECIST v1.1 or death from any cause, whichever occurred first. The median was estimated by using the Kaplan-Meier method and corresponding 2-sided 90% CI using Brookmeyer and Crowley methodology. | Up to approximately 30 months |
| Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1 | DCR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes [whether target or non-target] must have a reduction in short axis to <10 mm), PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), or stable disease (SD) (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. In numerical terms, it means a reduction in tumor size that is less than 30% [which is required for PR] and an increase in size that is less than 20% [which is required for PD]) as determined by the investigator per RECIST v1.1. | Up to approximately 30 months |
| Phase 1b Monotherapy: AUC0-tau of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1b Monotherapy: Cmax of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1b Monotherapy: Ctrough of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1b Monotherapy: CL of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1b Monotherapy: t1/2 of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1b Monotherapy: Vss of FPT155 | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
| Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment. | Cycle 1 (21-day cycles) Day 1 |
| Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | ORR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes [whether target or non-target] must have a reduction in short axis to <10 mm) or PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1. | Up to approximately 30 months |
| Darlinghurst |
| New South Wales |
| 2010 |
| Australia |
| Scientia Clinical Research | Randwick | New South Wales | 2031 | Australia |
| ICON | Auchenflower | Queensland | 4066 | Australia |
| Olivia Newton-John Cancer Center | Heidelberg | Victoria | 3084 | Australia |
| Cabrini Hospital | Malvern | Victoria | 3144 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| St Vincent Hospital of the Catholic University of Korea | Suwon | Gyeonggi-do | 16247 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Death |
|
| Lost to Follow-up |
|
| Other |
|
| Missing end of study status |
|
Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG002 | Phase 1a Monotherapy: FPT155 Dose C | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG003 | Phase 1a Monotherapy: FPT155 Dose D | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG004 | Phase 1a Monotherapy: FPT155 Dose E | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG005 | Phase 1a Monotherapy: FPT155 Dose F | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG006 | Phase 1a Monotherapy: FPT155 Dose G | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG007 | Phase 1a Monotherapy: FPT155 Dose H | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG008 | Phase 1a Monotherapy: FPT155 Dose I | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG009 | Phase 1a Monotherapy: FPT155 Dose J | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG010 | Phase 1a Monotherapy: FPT155 Dose K | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG011 | Phase 1a Monotherapy: FPT155 Dose L | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| BG012 | Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). |
| BG013 | Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). |
| BG014 | Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). |
| BG015 | Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K). |
| BG016 | Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab. |
| BG017 | Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab. |
| BG018 | Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab. |
| BG019 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Phase 1a Monotherapy: FPT155 Dose A | Participants with advanced solid tumours received FPT155 intravenously (IV) once every 3 weeks (Q3W) in escalating doses (A-L) until the recommended dose (RD) was identified. |
| OG001 | Phase 1a Monotherapy: FPT155 Dose B | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG002 | Phase 1a Monotherapy: FPT155 Dose C | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG003 | Phase 1a Monotherapy: FPT155 Dose D | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG004 | Phase 1a Monotherapy: FPT155 Dose E | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG005 | Phase 1a Monotherapy: FPT155 Dose F | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG006 | Phase 1a Monotherapy: FPT155 Dose G | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG007 | Phase 1a Monotherapy: FPT155 Dose H | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG008 | Phase 1a Monotherapy: FPT155 Dose I | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG009 | Phase 1a Monotherapy: FPT155 Dose J | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG010 | Phase 1a Monotherapy: FPT155 Dose K | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG011 | Phase 1a Monotherapy: FPT155 Dose L | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. |
| OG012 | Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). |
| OG013 | Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). |
| OG014 | Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). |
| OG015 | Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K). |
| OG016 | Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab. |
| OG017 | Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab. |
| OG018 | Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab. |
|
|
| Primary | Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | DLTs ware defined as any of the events that occurred during the first 28 days of treatment and were assessed by the Clinical Research Coordinator (CRC) as related to FPT155. | DLT-evaluable population: All participants enrolled into Phase 1a dose escalation portion of the study who received at least 1 dose of all assigned study drug(s) and remain on study for the 21-day DLT evaluation period, or who experienced a DLT before clearing the 21-day DLT evaluation interval. Study used a 3 + 3 design in the Phase 1a Monotherapy cohorts, from cohort "Phase 1a Monotherapy: FPT155 Dose E". | Posted | Count of Participants | Participants | Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days |
|
|
|
| Primary | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs | Represents the number of participants who had discontinuation of FPT155 dosing due to AEs. | Safety population: All participants who received any portion of a least one dose of FPT155. | Posted | Count of Participants | Participants | Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks. |
|
|
|
| Primary | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs | Represents the number of participants who had a modification in the dosing schedules of FPT155 due to AEs. | Safety population: All participants who received any portion of a least one dose of FPT155. | Posted | Count of Participants | Participants | Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks. |
|
|
|
| Primary | Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs | Represents the number of participants who had an interruption in the dosing schedules of FPT155 due to AEs. | Safety population: All participants who received any portion of a least one dose of FPT155. | Posted | Count of Participants | Participants | Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks. |
|
|
|
| Primary | Phase 1a Combination: Number of Participants Who Experienced DLTs | DLTs ware defined as any of the events that occur during the first 28 days of treatment and are assessed by the CRC as related to FPT155. | DLT-evaluable population: All participants enrolled into Phase 1a dose escalation portion of the study who received at least 1 dose of all assigned study drug(s) and remain on study for the 21-day DLT evaluation period, or who experienced a DLT before clearing the 21-day DLT evaluation interval. | Posted | Count of Participants | Participants | Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days |
|
|
|
| Secondary | Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | day*ug/mL | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | ug/mL | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | ug/mL | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1a Monotherapy: Clearance (CL) of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | mL/day | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | hours | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | mL | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment. | Safety population: All participants who received any portion of a least one dose of FPT155. | Posted | Count of Participants | Participants | Cycle 1 (21-day cycles) Day 1 |
|
|
|
| Secondary | Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1 | ORR was defined as the total number of participants with confirmed responses of either complete response (CR) (CR: The disappearance of all target lesions, any pathological lymph nodes [whether target or non-target] must have a reduction in short axis to <10 mm) or partial response (PR) (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1. | Efficacy Population: All participants who received any portion of at least one dose of FPT155. | Posted | Count of Participants | Participants | Up to approximately 30 months |
|
|
|
| Secondary | Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1 | DOR was defined as the time from first response (CR [The disappearance of all target lesions, any pathological lymph nodes {whether target or non-target} or PR [At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters] determined by the investigator per RECIST v1.1) that was subsequently confirmed until the onset of progressive disease (DP) (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study [this includes the baseline sum if that is the smallest on study]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) or death from any cause, whichever occurred first.](streamdown:incomplete-link) | Efficacy population inclusive of participants with CR or PR. | Posted | Up to approximately 30 months |
|
|
| Secondary | Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1 | PFS was defined as time from the first dose of study treatment until the first documentation by the investigator of DP (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study [this includes the baseline sum if that is the smallest on study]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) per RECIST v1.1 or death from any cause, whichever occurred first. The median was estimated by using the Kaplan-Meier method and corresponding 2-sided 90% CI using Brookmeyer and Crowley methodology. | Efficacy Population: All participants who received any portion of at least one dose of FPT155. | Posted | Median | 90% Confidence Interval | months | Up to approximately 30 months |
|
|
|
| Secondary | Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1 | DCR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes [whether target or non-target] must have a reduction in short axis to <10 mm), PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), or stable disease (SD) (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. In numerical terms, it means a reduction in tumor size that is less than 30% [which is required for PR] and an increase in size that is less than 20% [which is required for PD]) as determined by the investigator per RECIST v1.1. | Efficacy Population: All participants who received any portion of at least one dose of FPT155. | Posted | Count of Participants | Participants | Up to approximately 30 months |
|
|
|
| Secondary | Phase 1b Monotherapy: AUC0-tau of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | day*ug/mL | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1b Monotherapy: Cmax of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | ug/mL | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1b Monotherapy: Ctrough of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | ug/mL | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1b Monotherapy: CL of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | mL/day | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1b Monotherapy: t1/2 of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | day | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1b Monotherapy: Vss of FPT155 | PK-Evaluable Population: All participants who received at least one dose of study drug, and had sufficient PK sample for the calculation of at least one PK parameter on at least one Study Day, and had evaluable data. | Posted | Mean | Standard Deviation | mL | Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15 |
|
|
|
| Secondary | Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response | Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment. | Safety population: All participants who received any portion of a least one dose of FPT155. | Posted | Count of Participants | Participants | Cycle 1 (21-day cycles) Day 1 |
|
|
|
| Secondary | Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | ORR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes [whether target or non-target] must have a reduction in short axis to <10 mm) or PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1. | Efficacy Population: All participants who received any portion of at least one dose of FPT155. | Posted | Count of Participants | Participants | Up to approximately 30 months |
|
|
|
| 1 |
| 1 |
| 1 |
| 1 |
| 0 |
| 1 |
| EG001 | Phase 1a Monotherapy: FPT155 Dose B | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Phase 1a Monotherapy: FPT155 Dose C | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 1 | 2 | 1 | 2 | 2 | 2 |
| EG003 | Phase 1a Monotherapy: FPT155 Dose D | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 1 | 1 | 0 | 1 | 1 | 1 |
| EG004 | Phase 1a Monotherapy: FPT155 Dose E | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 2 | 4 | 1 | 4 | 3 | 4 |
| EG005 | Phase 1a Monotherapy: FPT155 Dose F | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 0 | 3 | 1 | 3 | 2 | 3 |
| EG006 | Phase 1a Monotherapy: FPT155 Dose G | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 1 | 3 | 3 | 3 | 3 | 3 |
| EG007 | Phase 1a Monotherapy: FPT155 Dose H | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG008 | Phase 1a Monotherapy: FPT155 Dose I | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 3 | 7 | 2 | 7 | 6 | 7 |
| EG009 | Phase 1a Monotherapy: FPT155 Dose J | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 2 | 10 | 3 | 10 | 10 | 10 |
| EG010 | Phase 1a Monotherapy: FPT155 Dose K | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 4 | 20 | 10 | 20 | 18 | 20 |
| EG011 | Phase 1a Monotherapy: FPT155 Dose L | Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. | 1 | 6 | 2 | 6 | 5 | 6 |
| EG012 | Phase 1b Monotherapy: 1bM1 FPT155 Dose K | Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). | 0 | 1 | 1 | 1 | 1 | 1 |
| EG013 | Phase 1b Monotherapy: 1bM2 FPT155 Dose K | Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). | 2 | 5 | 0 | 5 | 5 | 5 |
| EG014 | Phase 1b Monotherapy: 1bM3 FPT155 Dose K | Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). | 1 | 3 | 2 | 3 | 3 | 3 |
| EG015 | Phase 1b Monotherapy: 1bM4 FPT155 Dose K | Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K). | 0 | 1 | 0 | 1 | 1 | 1 |
| EG016 | Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG017 | Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab. | 0 | 3 | 3 | 3 | 3 | 3 |
| EG018 | Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg | Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab. | 1 | 3 | 2 | 3 | 2 | 3 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Biliary obstruction | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Central nervous system lesion | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Giant cell arteritis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Infusion site reaction | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Lumbosacral radiculopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Venous occlusion | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Cytokine release syndrome |
|
| Infusion related reaction |
|
| Title | Measurements |
|---|---|
|
| Aspartate aminotransferase increased |
|
| Anti-FPT155 Negative |
|
| Not Evaluable |
|
| Anti-FPT155 Negative |
|
| Not Evaluable |
|