A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Metastatic Solid Tumors Clinical Trial

Official title:

A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031441
• Other study ID #: GO44431
• Secondary ID: 2023-509266-38-0
• Status: Recruiting
• Phase: Phase 1
• Start date: November 27, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: GO44431 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

• Life expectancy >=3 months, in the investigator's judgment

• Adequate hematologic and end-organ function

• Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care

• Measurable disease per RECIST v1.1

• Tumor specimen availability, for certain cohorts

Exclusion Criteria:

• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions

• Active hepatitis B or C

• Active tuberculosis

• Positive test for HIV infection

• Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

• Active or history of autoimmune disease

• Prior allogeneic stem cell or organ transplantation

• Uncontrolled tumor-related pain

• Significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Locally Advanced Solid Tumors
• Metastatic Solid Tumors
• Neoplasms
• Recurrent Solid Tumors

Intervention

Drug:
• RO7566802
RO7566802 solution for infusion will be administered as specified in each treatment arm.
• Atezolizumab
Atezolizumab solution for infusion will be administered as specified in each treatment arm.

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Peter Maccallum Cancer Centre	Melbourne	Victoria
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with DLTs		Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days)
Primary	Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)		Up to approximately 39 months
Secondary	Area Under the Serum Concentration Time Curve (AUC) of RO7566802		Up to approximately 39 months
Secondary	Maximum Serum Concentration (Cmax) of RO7566802		Up to approximately 39 months
Secondary	Minimum Serum Concentration (Cmin) of RO7566802		Up to approximately 39 months
Secondary	Total Clearance (CL) of RO7566802		Up to approximately 39 months
Secondary	Volume of Distribution at Steady State (Vss) of RO7566802		Up to approximately 39 months
Secondary	Serum Concentration of Atezolizumab		Up to approximately 39 months
Secondary	Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)		Up to approximately 39 months
Secondary	Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802		From Baseline up to approximately 39 months