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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06031441

Collaborator

(none)

250

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Solid Tumors Recurrent Solid Tumors Metastatic Solid Tumors	Drug: RO7566802 Drug: Atezolizumab	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 2, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation Cohort Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.	Drug: RO7566802 RO7566802 solution for infusion will be administered as specified in each treatment arm. Drug: Atezolizumab Atezolizumab solution for infusion will be administered as specified in each treatment arm. Other Names: Tecentriq®
Experimental: Dose Expansion Cohort Participants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.	Drug: RO7566802 RO7566802 solution for infusion will be administered as specified in each treatment arm. Drug: Atezolizumab Atezolizumab solution for infusion will be administered as specified in each treatment arm. Other Names: Tecentriq®

Arm

Intervention/Treatment

Experimental: Dose Escalation Cohort

Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Drug: RO7566802

RO7566802 solution for infusion will be administered as specified in each treatment arm.

Drug: Atezolizumab

Atezolizumab solution for infusion will be administered as specified in each treatment arm.

Other Names:

Tecentriq®

Experimental: Dose Expansion Cohort

Participants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Drug: RO7566802

RO7566802 solution for infusion will be administered as specified in each treatment arm.

Drug: Atezolizumab

Atezolizumab solution for infusion will be administered as specified in each treatment arm.

Other Names:

Tecentriq®

Outcome Measures

Primary Outcome Measures

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)]
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 Outcome Measures

Area Under the Serum Concentration Time Curve (AUC) of RO7566802 [Up to approximately 39 months]
Maximum Serum Concentration (Cmax) of RO7566802 [Up to approximately 39 months]
Minimum Serum Concentration (Cmin) of RO7566802 [Up to approximately 39 months]
Total Clearance (CL) of RO7566802 [Up to approximately 39 months]
Volume of Distribution at Steady State (Vss) of RO7566802 [Up to approximately 39 months]
Serum Concentration of Atezolizumab [Up to approximately 39 months]
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]
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802 [From Baseline up to approximately 39 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Measurable disease per RECIST v1.1
Disease that has progressed after at least one available standard therapy, and for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate, or for which a clinical trial of an investigational agent is a recognized standard of care
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Genentech, Inc.

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genentech, Inc.

ClinicalTrials.gov Identifier:

NCT06031441

Other Study ID Numbers:

GO44431

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Atezolizumab

Study Results

No Results Posted as of Sep 11, 2023