Recurrent Cancer, Refractory Cancer, Solid Tumor, Adult
Conditions
Brief summary
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.
Interventions
DRUGRO7617991
RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
DRUGTocilizumab
Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Body weight ≥40 kilograms * Life expectancy of at least 12 weeks * Confirmed eligible HLA-A\*02 genotype and tumor with confirmed MAGE-A4 expression * Histologically confirmed locally advanced or metastatic solid tumor malignancy that has relapsed or is refractory to established therapies * Measurable disease, according to RECIST v1.1 * Adequate hematologic and end-organ function * Resolution to Grade ≤2 of all acute, clinically significant treatment-related toxicity from prior therapy * An archival tumor tissue specimen or fresh baseline biopsy (when archival is not available) is required
Exclusion criteria
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of RO7617991 or tocilizumab * Clinically significant cardiopulmonary dysfunction * Clinically significant liver disease * Poorly controlled Type 2 diabetes mellitus * Active hepatitis B or C infection * Positive test for human immunodeficiency virus (HIV) * History of allergic reactions to red meat or tick bites or known galactose-alpha-1,3-galactose (alpha-gal) hypersensitivity * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Symptomatic pleural effusion, pericardial effusion, or ascites or any prior procedural intervention for pleural effusion, pericardial effusion, or ascites within 6 weeks prior to enrollment * Active or history of autoimmune disease or immune deficiency * Treatment with systemic immunosuppressive medications * Prior allogeneic stem cell or solid organ transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years) | The targeted vital signs include pulse rate, respiratory rate, systolic and diastolic blood pressure, pulse oximetry, and body temperature. |
| 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) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| 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) | — |
| Overall Survival (OS) | From enrollment to death from any cause (up to approximately 3 years) | — |
| Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1 | From Baseline until until radiographic disease progression or loss of clinical benefit (up to approximately 3 years) | RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1 |
| 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) | — |
Outcome results
None listed