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

Part of paid clinical trials in Houston, Texas.

Sponsor
Hoffmann-La Roche
Study ID
NCT04642365
Phase
PHASE1
Status
Terminated

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7296682 — DRUG
    RO7296682 will be administered as per the schedules specified in the respective arms.
  • Atezolizumab — DRUG
    Atezolizumab will be administered as per the schedules specified in the respective arms.

Study Details

This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.

Key Dates

Start date
Jan 4, 2021
Status verified
May 2025
Primary completion
Jan 4, 2024
Completion
Jan 4, 2024

Study Design

Enrollment
49 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part I
    Dose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682 with a fixed dose of Atezolizumab, every three weeks (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined.
  • Experimental: Part II
    Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I. Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab.
  • Experimental: Part III (Exploratory)
    Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I and if clinical activity is seen in this trial or in the single agent study (WP41188). Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab at the dosing regimen established in Part I.

Primary Outcome Measure

Part 1: Number of Participants With Adverse Events (AEs) [ Time Frame: From Day 1 up to the end of safety follow-up (up to 28.5 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

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By research site
MD Anderson Cancer Center· Houston, TX

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