Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002830-35 | EudraCT Number | ||
| RG6292 | Other Identifier | Hoffmann-La Roche |
Not provided
Not provided
Not provided
Halted in order to focus on the ongoing combination of RO7296682 with Atezolizumab, evaluated in study BP42595, as a higher likelihood for efficacy is expected in combination with Atezolizumab as compared to the monotherapy setting.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was planned to evaluate the safety and tolerability of RO7296682 in participants with advanced solid tumors.
A Phase 1, open-label, dose-escalation study designed to evaluate the safety and tolerability of RO7296682 in participants with advanced and/or metastatic solid tumors. RO7296682 was administered by IV infusion Q3W. This entry-into-human study is divided into a dose-escalation stage (Part A) and a dose expansion stage (Part B).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Cohort 1 RO7296682 0.3 mg Q3W | Experimental | Participants with non-small cell lung cancer (NSCLC), melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), ovarian cancer (OvC), triple-negative breast cancer (TNBC), and esophageal carcinoma (EsC) received RO7296682 0.3 milligram (mg) intravenous (IV) infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, every 3 weeks (Q3W). Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| Part A: Cohort 2 RO7296682 1 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| Part A: Cohort 3 RO7296682 2 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| Part A: Cohort 4 RO7296682 6 mg Q3W | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7296682 | Drug | RO7296682 will be administered by the schedules specified in the respective arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) Determined According to The National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. | From signing of informed consent form (ICF) until last follow-up visit (Up to approximately 2 years 7 months) |
| Number of Participants With Dose Limiting Toxicities (DLTs) | A DLT was defined as occurrence of a clinically significant adverse event (AE) from first administration of RO7296682 up to 7 days after second administration of RO7296682. DLTs were defined as following: 1) Hematologic toxicities - Grade 4 neutropenia lasting >=7 days, Grade >=3 febrile neutropenia, Grade 4 thrombocytopenia lasting >=48 hours, Grade 3 thrombocytopenia associated with bleeding episode and Grade 4 anemia 2) Nonhematologic toxicities - Grade 3 nausea, vomiting or diarrhea, Grade >=3 fatigue, Grade 3 arthralgia, fever >40 degree Celsius occurs within 48 hours, Grade >+ laboratory abnormalities, Grade 3 autoimmune thyroiditis or other endocrine abnormalities, Grade 3 tumor flare, Grade 3 transient increase of bilirubin in participants with liver lesions, transaminases (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) and/or gamma-glutamyl transferase (GGT) and any other RO7296682-related toxicity significant enough to be qualified as DLT. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigators' assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters in the absence of CR. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Centre; Medical Oncology | Melbourne | Victoria | 3000 | Australia | ||
| Cliniques Universitaires St-Luc |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Not provided
Not provided
Not provided
Not provided
A total of 76 participants with non-small cell lung cancer (NSCLC), melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), ovarian cancer (OvC), triple-negative breast cancer (TNBC), and esophageal carcinoma (EsC) were enrolled in Part A. No Participants were enrolled in Part B.
Participants took part in Part A of the study at 11 centers in Australia, Belgium, Canada, Denmark and Spain from 09 December 2019 to 21 July 2022. The study was terminated before Part B was initiated.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Cohort 1 RO7296682 0.3 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| FG001 | Part A: Cohort 2 RO7296682 1 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| FG002 | Part A: Cohort 3 RO7296682 2 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| FG003 | Part A: Cohort 4 RO7296682 6 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| FG004 | Part A: Cohort 5 RO7296682 18 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| FG005 | Part A: Cohort 6 RO7296682 35 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| FG006 | Part A: Cohort 7 RO7296682 70 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| FG007 | Part A: Cohort 8 RO7296682 100 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| FG008 | Part A: Cohort 9 RO7296682 165 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| FG009 | Part A: Cohort 10 RO7296682 20 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Cohort 1 RO7296682 0.3 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| 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 With Adverse Events (AE) Determined According to The National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. | Posted | Count of Participants | Participants | From signing of informed consent form (ICF) until last follow-up visit (Up to approximately 2 years 7 months) |
|
Up to approximately 2 years 7 months
Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
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 | Part A: Cohort 1 RO7296682 0.3 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-La-Roche | 800 821-8590 | genentech@druginfo.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2021 | Jul 19, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| Part A: Cohort 5 RO7296682 18 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| Part A: Cohort 6 RO7296682 35 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| Part A: Cohort 7 RO7296682 70 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| Part A: Cohort 8 RO7296682 100 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| Part A: Cohort 9 RO7296682 165 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| Part A: Cohort 10 RO7296682 20 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
| From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months ) |
| Disease Control Rate (DCR) | DCR defined as the percentage of participants with an overall response of either CR, PR, or stable disease (SD), based on Investigators' assessment using RECIST Version 1.1. CR is defined as disappearance of all target lesions. any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PD is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). | From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months) |
| Duration of Response (DOR) | DOR is defined as the time from first occurrence of a documented objective response to disease progression as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. Objective response is defined as the percentage of participants having a CR or PR as determined by investigators' assessment of radiographic disease per RECIST v1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters in the absence of CR. | From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months) |
| On-Treatment Progression Free Survival (PFS) | The PFS on treatment was defined as the time from study treatment initiation (Cycle 1 Day 1, (1 cycle=21 days) ) to the first occurrence of documented disease progression based on RECIST Version 1.1 Investigator's assessment, or death from any cause, whichever occurred first. For participants who did not have documented progressive disease or death (within 30 days from last study treatment) during the study, PFS was censored at the day of the last tumor assessment. Participants without any post baseline assessments or with all post-baseline assessments having unknown result/response but known to be alive at the clinical cut off for the analysis would be censored at the date of study treatment initiation plus one day. | From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months) |
| Area Under the Serum Concentration Time Curve (AUC) of RO7296682 | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
| Minimum Serum Concentration (Cmin) of RO7296682 | Cycles 3 or 4 (Cycle length = 21 days) |
| Maximum Serum Concentration (Cmax) of RO7296682 | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
| Total Clearance (CL) of RO7296682 | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
| Volume of Distribution at Steady State (Vss) of RO7296682 | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
| Terminal Half-Life (T1/2) of RO7296682 | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
| Time of Maximum Concentration (Tmax) of RO7296682 | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
| Number of Participants With Anti-Drug Antibodies (ADA) During the Study Relative to the Prevalence of ADA at Baseline | Predose on Day 1 of each 21-day and subsequent cycles up to end of study (Up to approximately 2 years 7 months) |
| Treatment-induced Changes in Treg Levels in Blood and/or Tumor as Compared to Baseline | Baseline and at Cycle 1 Day 4 (Cycle length = 21 days) |
| Treatment-induced Changes in Treg/Teff (T-regulatory Cell; T-effector Cell) Ratio in Blood and/or Tumor as Compared to Baseline | Baseline and at Cycle 1 Day 4 (Cycle length = 21 days) |
| Brussels |
| 1200 |
| Belgium |
| BC Cancer Agency - Vancouver | Vancouver | British Columbia | V5Z 4E6 | Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K2H 6C2 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 1Z5 | Canada |
| Rigshospitalet; Onkologisk Klinik | København Ø | 2100 | Denmark |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Vall d?Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| START Madrid-FJD, Hospital Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| START Madrid. Centro Integral Oncologico Clara Campal; CIOCC | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| Study Terminated by Sponsor |
|
| Progressive Disease |
|
| Lost to Follow-up |
|
| Due To Patient Status |
|
| Death |
|
| Clinical Progression Disease |
|
| Clinical Progression |
|
| Clinical Deterioration |
|
| BG001 | Part A: Cohort 2 RO7296682 1 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| BG002 | Part A: Cohort 3 RO7296682 2 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| BG003 | Part A: Cohort 4 RO7296682 6 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| BG004 | Part A: Cohort 5 RO7296682 18 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| BG005 | Part A: Cohort 6 RO7296682 35 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| BG006 | Part A: Cohort 7 RO7296682 70 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| BG007 | Part A: Cohort 8 RO7296682 100 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| BG008 | Part A: Cohort 9 RO7296682 165 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| BG009 | Part A: Cohort 10 RO7296682 20 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| BG010 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Part A: Cohort 1 RO7296682 0.3 mg Q3W |
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| OG001 | Part A: Cohort 2 RO7296682 1 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| OG002 | Part A: Cohort 3 RO7296682 2 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| OG003 | Part A: Cohort 4 RO7296682 6 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| OG004 | Part A: Cohort 5 RO7296682 18 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| OG005 | Part A: Cohort 6 RO7296682 35 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| OG006 | Part A: Cohort 7 RO7296682 70 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| OG007 | Part A: Cohort 8 RO7296682 100 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| OG008 | Part A: Cohort 9 RO7296682 165 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| OG009 | Part A: Cohort 10 RO7296682 20 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
|
|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | A DLT was defined as occurrence of a clinically significant adverse event (AE) from first administration of RO7296682 up to 7 days after second administration of RO7296682. DLTs were defined as following: 1) Hematologic toxicities - Grade 4 neutropenia lasting >=7 days, Grade >=3 febrile neutropenia, Grade 4 thrombocytopenia lasting >=48 hours, Grade 3 thrombocytopenia associated with bleeding episode and Grade 4 anemia 2) Nonhematologic toxicities - Grade 3 nausea, vomiting or diarrhea, Grade >=3 fatigue, Grade 3 arthralgia, fever >40 degree Celsius occurs within 48 hours, Grade >+ laboratory abnormalities, Grade 3 autoimmune thyroiditis or other endocrine abnormalities, Grade 3 tumor flare, Grade 3 transient increase of bilirubin in participants with liver lesions, transaminases (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) and/or gamma-glutamyl transferase (GGT) and any other RO7296682-related toxicity significant enough to be qualified as DLT. | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
| Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigators' assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters in the absence of CR. | Intent-to Treat (ITT) population included all participants who received at least one dose of RO7296682, and who had at least one baseline and one on-study tumor assessment. Participants who received at least one dose of study drug and discontinued the study because of progression before the first on-study tumor assessment were considered as response-evaluable were included in the efficacy analyses. Participants with missing or no response assessments were classified as not evaluable. | Posted | Number | 95% Confidence Interval | percentage of participants | From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months ) |
|
|
|
| Secondary | Disease Control Rate (DCR) | DCR defined as the percentage of participants with an overall response of either CR, PR, or stable disease (SD), based on Investigators' assessment using RECIST Version 1.1. CR is defined as disappearance of all target lesions. any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PD is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). | ITT population included all participants who received at least one dose of RO7296682, and who had at least one baseline and one on-study tumor assessment. Participants who received at least one dose of study drug and discontinued the study because of progression before the first on-study tumor assessment were considered as response-evaluable were included in the efficacy analyses. Participants with missing or no response assessments were classified as not evaluable. | Posted | Number | 95% Confidence Interval | percentage of participants | From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months) |
|
|
|
| Secondary | Duration of Response (DOR) | DOR is defined as the time from first occurrence of a documented objective response to disease progression as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. Objective response is defined as the percentage of participants having a CR or PR as determined by investigators' assessment of radiographic disease per RECIST v1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters in the absence of CR. | Participants who received at least one dose of study drug and discontinued the study because of progression before the first on-study tumor assessment were considered as response-evaluable were included in the efficacy analyses. No participants had an objective response, Hence DOR could not be measured. | Posted | From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months) |
|
|
| Secondary | On-Treatment Progression Free Survival (PFS) | The PFS on treatment was defined as the time from study treatment initiation (Cycle 1 Day 1, (1 cycle=21 days) ) to the first occurrence of documented disease progression based on RECIST Version 1.1 Investigator's assessment, or death from any cause, whichever occurred first. For participants who did not have documented progressive disease or death (within 30 days from last study treatment) during the study, PFS was censored at the day of the last tumor assessment. Participants without any post baseline assessments or with all post-baseline assessments having unknown result/response but known to be alive at the clinical cut off for the analysis would be censored at the date of study treatment initiation plus one day. | ITT population included all participants who received at least one dose of RO7296682, and who had at least one baseline and one on-study tumor assessment. Participants who received at least one dose of study drug and discontinued the study because of progression before the first on-study tumor assessment were considered as response-evaluable were included in the efficacy analyses. | Posted | Median | 95% Confidence Interval | days | From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months) |
|
|
|
| Secondary | Area Under the Serum Concentration Time Curve (AUC) of RO7296682 | Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*micrograms per milliliter(h*μg/mL) | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
|
|
|
| Secondary | Minimum Serum Concentration (Cmin) of RO7296682 | Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycles 3 or 4 (Cycle length = 21 days) |
|
|
|
| Secondary | Maximum Serum Concentration (Cmax) of RO7296682 | Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
|
|
|
| Secondary | Total Clearance (CL) of RO7296682 | Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliter per hour (mL/h) | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vss) of RO7296682 | Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliter (mL) | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
|
|
|
| Secondary | Terminal Half-Life (T1/2) of RO7296682 | Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis. | Posted | Median | Full Range | hours | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
|
|
|
| Secondary | Time of Maximum Concentration (Tmax) of RO7296682 | Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis. | Posted | Median | Full Range | hours | Cycles 1, and 3 or 4 (Cycle length = 21 days) |
|
|
|
| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) During the Study Relative to the Prevalence of ADA at Baseline | Immunogenicity analyses population included all participants with at least one ADA assessment, irrespective of whether or not the participant received any treatment. | Posted | Count of Participants | Participants | Predose on Day 1 of each 21-day and subsequent cycles up to end of study (Up to approximately 2 years 7 months) |
|
|
|
| Secondary | Treatment-induced Changes in Treg Levels in Blood and/or Tumor as Compared to Baseline | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Number analyzed is the number of participants with data available for analysis. | Posted | Mean | Standard Deviation | percent cells per microliter (cells/µL) | Baseline and at Cycle 1 Day 4 (Cycle length = 21 days) |
|
|
|
| Secondary | Treatment-induced Changes in Treg/Teff (T-regulatory Cell; T-effector Cell) Ratio in Blood and/or Tumor as Compared to Baseline | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Number analyzed is the number of participants with data available for analysis. | Posted | Mean | Standard Deviation | ratio | Baseline and at Cycle 1 Day 4 (Cycle length = 21 days) |
|
|
|
| 3 |
| 5 |
| 1 |
| 5 |
| 5 |
| 5 |
| EG001 | Part A: Cohort 2 RO7296682 1 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. | 4 | 5 | 2 | 5 | 5 | 5 |
| EG002 | Part A: Cohort 3 RO7296682 2 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. | 5 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Part A: Cohort 4 RO7296682 6 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. | 7 | 14 | 7 | 14 | 14 | 14 |
| EG004 | Part A: Cohort 5 RO7296682 18 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. | 5 | 8 | 3 | 8 | 8 | 8 |
| EG005 | Part A: Cohort 6 RO7296682 35 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. | 4 | 5 | 0 | 5 | 5 | 5 |
| EG006 | Part A: Cohort 7 RO7296682 70 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. | 10 | 15 | 5 | 15 | 14 | 15 |
| EG007 | Part A: Cohort 8 RO7296682 100 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. | 4 | 6 | 0 | 6 | 6 | 6 |
| EG008 | Part A: Cohort 9 RO7296682 165 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. | 1 | 6 | 1 | 6 | 6 | 6 |
| EG009 | Part A: Cohort 10 RO7296682 20 mg Q3W | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. | 2 | 6 | 1 | 6 | 6 | 6 |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Eyelid skin dryness | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Lip oedema | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Serum ferritin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Tumour inflammation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Cranial nerve disorder | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Sterile pyuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
|
| Cycle 3/4 |
|
|
|
| Cycle 3/4 |
|
|
|
| Cycle 3/4 |
|
|
|
| Cycle 3/4 |
|
|
|
| Cycle 3/4 |
|
|
|
| Cycle 3/4 |
|
|
|
| %CD4 Treg: Change from Baseline at Cycle 1 Day 4 |
|
|
|
| Treg/Teff Ratio: Change from Baseline at Cycle 1 Day 4 |
|
|