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GO44669 study has been withdrawn due to an internal Sponsor decision. The decision was not due to any safety or efficacy concerns with the study drug.
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This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7617991 Dose Escalation and Expansion | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7617991 | Drug | RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events | From first dose until 90 days after the final dose of study treatment (up to approximately 3 years) | |
| Number of Participants with Abnormal Values in Targeted Vital Signs | The targeted vital signs include pulse rate, respiratory rate, systolic and diastolic blood pressure, pulse oximetry, and body temperature. | From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years) |
| Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters | From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of RO7617991 at Specific Timepoints | From first dose until 30 days after the final dose of study treatment (up to approximately 3 years) | |
| Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1 | RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Tocilizumab | Drug | Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol. |
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| From Baseline until until radiographic disease progression or loss of clinical benefit (up to approximately 3 years) |
| Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1 | From first occurrence of a confirmed objective response to disease progression or death, whichever occurs first (up to approximately 3 years) |
| Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 | From enrollment to the first occurrence of disease progression or relapse or death, whichever occurs first (up to approximately 3 years) |
| Overall Survival (OS) | From enrollment to death from any cause (up to approximately 3 years) |
| Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study | Baseline (predose) and from first dose until 90 days after the final dose of study treatment (up to approximately 3 years) |