NCT05240898

A Phase 1 Study of RO7623066 Alone and in Combination in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study to assess the safety and clinical activity of RO7623066 alone and in combination in patients with advanced solid tumors.

Detailed description

This is a Phase 1 study consisting of 2 parts: Dose Escalation and Expansion to evaluate the safety, tolerability, clinical activity, and pharmacokinetics (PK) Study of RO7623066 as a Monotherapy or in Combination in Patients with Advanced Solid Tumors, and a Food Effect Cohort.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	RO7623066	Administered orally in capsule
DRUG	Olaparib	Administered orally. Dose levels and schedules will be selected based on integration of preclinical data as well as clinical PK, safety, efficacy, and PD/biomarker data (as appropriate) from the dose escalation cohorts.
DRUG	Carboplatin	Administered intravenously.

Timeline

• Start date: 2021-08-26
• Primary completion: 2025-11-26
• Completion: 2025-11-26
• First posted: 2022-02-15
• Last updated: 2025-12-18

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study