A 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

Conditions

• Solid Tumour

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RO7759065 — DRUG
  Specified dose on specified days
• Atezolizumab — DRUG
  Specified dose on specified days

Study Details

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.

Key Dates

Start date

Dec 16, 2024

Status verified

Dec 2025

Primary completion

Nov 5, 2025

Completion

Nov 5, 2025

Study Design

Enrollment

12 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase Ia: Dose Escalation
• Experimental: Phase Ia: Expansion
• Experimental: Phase Ib: Dose Escalation
• Experimental: Phase Ib: Expansion

Primary Outcome Measure

Number of Participants iwth Dose Limiting Toxicity (DLTs) [ Time Frame: Up to approximately 5 years ]

Locations (4)

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