The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, immune response and preliminary anti-tumor activity of RO7515629 alone in participants with advanced or metastatic solid tumors expressing human leukocyte antigen G (HLA-G).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.
Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 15 months
Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: From start of study treatment (cycle 0 day -7 or cycle 0 day -14) until two weeks after second or third RO7515629 infusion (cycle 1 day 1) for a total DLT window of up to 28 days.
Part 1, 2, 3: Pharmacokinetic Analysis: Maximum Serum Concentration (Cmax) of RO7515629
Time frame: Up to 13 months
Part 1, 2, 3: Pharmacokinetic Analysis: Time of Maximum Serum Concentration (Tmax) of RO7515629
Time frame: Up to 13 months
Part 1, 2, 3: Pharmacokinetic Analysis: Minimum Serum Concentration (Cmin) of RO7515629
Time frame: Up to 13 months
Parts 1, 2, 3: Pharmacokinetic Analysis: Clearance (CL) of RO7515629
Time frame: Up to 13 months
Part 1, 2, 3: Pharmacokinetic Analysis: Volume of Distribution at Steady State (Vss) of RO7515629
Time frame: Up to 13 months
Part 1, 2, 3: Pharmacokinetic Analysis: Area Under The Curve (AUC) of RO7515629
Time frame: Up to 13 months
Part 1, 2, 3: Number of Participants With RO7515629 Anti-drug Antibodies (ADAs)
Time frame: Up to 13 months
Part 1, 2, 3: Objective Response Rate (ORR)
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Time frame: Up to approximately 18 months
Part 1, 2, 3: Disease Control Rate (DCR)
Time frame: Up to approximately 18 months
Part 1, 2, 3: Duration of Response (DoR)
Time frame: Up to approximately 18 months
Part 1, 2, 3: Progression Free Survival (PFS)
Time frame: Up to approximately 18 months
Part 1, 2, 3: Overall survival (OS)
Defined as the time from first dose of study treatment to time of death.
Time frame: Up to approximately 18 months