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Monoclonal Antibodies

A Study to Evaluate the Safety and Tolerability of RO7296682 in Participants With Advanced Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment initiation until last follow-up visit (up to approximately 2 years 7 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, RO7296682, for safety in patients with advanced or spreading solid tumors. The drug is given through an IV periodically to check for tolerability.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment initiation until last follow-up visit (up to approximately 2 years 7 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment initiation until last follow-up visit (up to approximately 2 years 7 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Adverse Events (AE) Determined According to The National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0)
Number of Participants With Dose Limiting Toxicities (DLTs)
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DOR)
Objective Response Rate (ORR)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups
Experimental Treatment
Group I: Part A: Cohort 9 RO7296682 165 mg Q3WExperimental Treatment1 Intervention
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Group II: Part A: Cohort 8 RO7296682 100 mg Q3WExperimental Treatment1 Intervention
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Group III: Part A: Cohort 7 RO7296682 70 mg Q3WExperimental Treatment1 Intervention
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Group IV: Part A: Cohort 6 RO7296682 35 mg Q3WExperimental Treatment1 Intervention
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Group V: Part A: Cohort 5 RO7296682 18 mg Q3WExperimental Treatment1 Intervention
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Group VI: Part A: Cohort 4 RO7296682 6 mg Q3WExperimental Treatment1 Intervention
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Group VII: Part A: Cohort 3 RO7296682 2 mg Q3WExperimental Treatment1 Intervention
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Group VIII: Part A: Cohort 2 RO7296682 1 mg Q3WExperimental Treatment1 Intervention
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Group IX: Part A: Cohort 10 RO7296682 20 mg Q3WExperimental Treatment1 Intervention
Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Group X: Part A: Cohort 1 RO7296682 0.3 mg Q3WExperimental Treatment1 Intervention
Participants with non-small cell lung cancer (NSCLC), melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), ovarian cancer (OvC), triple-negative breast cancer (TNBC), and esophageal carcinoma (EsC) received RO7296682 0.3 milligram (mg) intravenous (IV) infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, every 3 weeks (Q3W). Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7296682
2021
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,459 Previous Clinical Trials
1,096,968 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
895,914 Total Patients Enrolled
~13 spots leftby Dec 2025
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