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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol.
Incidence and Severity of Adverse Events
Time frame: 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.
Time frame: 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
Time frame: From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
Serum Concentration of RO7617991 at Specific Timepoints
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the first occurrence of disease progression or relapse or death, whichever occurs first (up to approximately 3 years)
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Overall Survival (OS)
Time frame: 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
Time frame: Baseline (predose) and from first dose until 90 days after the final dose of study treatment (up to approximately 3 years)