NCT06488716
Terminated
Phase 1
A Phase Ia/Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
ConditionsSolid Tumour
Overview
- Phase
- Phase 1
- Intervention
- RO7759065
- Conditions
- Solid Tumour
- Sponsor
- Genentech, Inc.
- Enrollment
- 12
- Locations
- 11
- Primary Endpoint
- Number of Participants iwth Dose Limiting Toxicity (DLTs)
- Status
- Terminated
- Last Updated
- 4 months ago
Overview
Brief Summary
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Life expectancy at least 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hematologic and end-organ function
- •Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
- •Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
- •Availability of representative tumor specimens required for patients in select cohorts.
Exclusion Criteria
- •Women who are pregnant or breastfeeding
- •Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
- •Active hepatitis B or C or tuberculosis
- •Positive test for human immunodeficiency virus (HIV) infection
- •Acute or chronic active Epstein-Barr virus (EBV) infection at screening
- •Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7759065 infusion
- •Primary, untreated, or active central nervous system (CNS) metastases
- •Active or history of autoimmune disease or immune deficiency
- •Prior allogeneic stem cell or organ transplantation
- •Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent
Arms & Interventions
Phase Ia: Dose Escalation
Intervention: RO7759065
Phase Ia: Expansion
Intervention: RO7759065
Phase Ib: Dose Escalation
Intervention: RO7759065
Phase Ib: Dose Escalation
Intervention: Atezolizumab
Phase Ib: Expansion
Intervention: RO7759065
Phase Ib: Expansion
Intervention: Atezolizumab
Outcomes
Primary Outcomes
Number of Participants iwth Dose Limiting Toxicity (DLTs)
Time Frame: Up to approximately 5 years
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 5 years
Secondary Outcomes
- Objective Response Rate (ORR)(Up to Approximately 5 Years)
- Duration of Response (DOR)(Up to approximately 5 years)
- Maximum Serum Concentration (Cmax) of RO7759065(Up to approximately 5 years)
- Progression Free Survival (PFS)(Up to approximately 5 years)
- Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065(Up to approximately 5 years)
Study Sites (11)
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