A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors

Sponsor
Hoffmann-La Roche
Study ID
NCT04857138
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • RO7300490 — DRUG
    Participants will receive RO7300490, as described in the Arm Descriptions.
  • Atezolizumab — DRUG
    Participants will receive Atezolizumab, as described in the Arm Descriptions.

Study Details

A study to evaluate the safety, pharmacokinetics and anti-tumor activity of RO7300490 as a single agent or in combination with atezolizumab. The study will consist of 3 parts: \[Part 1\] Dose-Escalation of RO7300490 as a single agent; \[Part 2\] Dose-Escalation of RO7300490 in combination with atezolizumab and \[Part 3\] Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types.

Key Dates

Start date
May 18, 2021
Status verified
Feb 2024
Primary completion
Jan 18, 2024
Completion
Jan 18, 2024

Study Design

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

Arms

  • Experimental: Part 1: Dose Escalation (RO7300490 Monotherapy)
    Participants will receive escalating doses of RO7300490 intravenously (IV) as a single agent for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent.
  • Experimental: Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy)
    Participants will receive escalating doses of RO7300490 in combination with a fixed dose of atezolizumab IV (as per label) for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent.
  • Experimental: Part 3: Dose Expansion (Disease-specific Expansion(s))
    Participants with selected types of advanced and/or metastatic tumors will receive the maximum tolerated dose (MTD) or recommended dose for expansion (RDE) (determined from Parts 1 and 2) of RO7300490 in combination with a fixed dose of atezolizumab IV (as per label). Treatment will be administered for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2) [ Time Frame: Up to 36 months ]

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