A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Gastric Cancer Clinical Trial

Official title:

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 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: NCT05581004
• Other study ID #: GO43860
• Secondary ID: 2021-006708-34
• Status: Recruiting
• Phase: Phase 1
• Start date: October 20, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: GO43860 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 study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 395
• Est. completion date: October 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Life expectancy at least 12 weeks

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1

• Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy

• Tumor Specimen availability

Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment

• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment

• Active hepatitis B or C or tuberculosis

• Positive test for human immunodeficiency virus (HIV) infection

• Acute or chronic active Epstein-Barr virus (EBV) infection at screening

• Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion

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

• Active or history of autoimmune disease

• Prior allogeneic stem cell or organ transplantation

Related Conditions & MeSH terms

• Cervical Cancer
• Clear Cell RCC
• Esophageal Cancer
• Gastric Cancer
• HCC
• HNSCC
• Locally Advanced or Metastatic Solid Tumors
• Melanoma
• NSCLC
• Urothelial Carcinoma

Intervention

Drug:
• RO7502175
RO7502175 will be administered as per the schedules specified in the respective arms.
• Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.

Locations

Country	Name	City	State
Australia	Monash Health Monash Medical Centre	Clayton	Victoria
Australia	Kinghorn Cancer Centre; St Vincents Hospital	Darlinghurst	New South Wales
Australia	Linear Clinical Research Ltd	Nedlands	Western Australia
Belgium	UZ Antwerpen	Edegem
Belgium	CHU de Liège	Liège
Belgium	GasthuisZusters Antwerpen	Wilrijk
Canada	Sir Mortimer B Davis Jewish General Hospital	Montreal	Quebec
Canada	Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Korea, Republic of	Asan Medical Center - PPDS	Seoul
Korea, Republic of	Samsung Medical Center - PPDS	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy	Seoul
Netherlands	Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Spain	Hospital Universitario Vall d'Hebron - PPDS	Barcelona
Spain	ICO l?Hospitalet ? Hospital Duran i Reynals	L?Hospitalet De Llobregat	Barcelona
Spain	Hospital Universitario 12 De Octubre	Madrid
Spain	START MADRID_Hospital Universiario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Spain	Hospital Clinico Universitario de Valencia	Valencia
United States	Winship Cancer Institute	Atlanta	Georgia
United States	University Of Colorado	Aurora	Colorado
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Henry Ford Hospital	Detroit	Michigan
United States	The West Clinic - Memphis (Union Ave)	Germantown	Tennessee
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Washington University Medical Center, Division of Oncology	Saint Louis	Missouri
United States	South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas
United States	Stanford University'	San Francisco	California
United States	Florida Cancer Specialists - Sarasota	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Korea, Republic of,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)		From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
Primary	Phase Ib: Number of Participants with DLTs		From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
Primary	Phase Ia: Number of Participants with Treatment Emergent Adverse Events		Up to approximately 5 years
Primary	Phase Ib: Number of Participants with Treatment Emergent Adverse Events		Up to approximately 5 years
Secondary	Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175		From Cycle 1 (each cycle is 21 days) Day1 and at multiple timepoints up to each follow-up visits (up to approximately 5 years)
Secondary	Phase Ia and Phase Ib: Objective Response Rate (ORR)		From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
Secondary	Phase Ia and Phase Ib: Duration of Response (DOR)		From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
Secondary	Phase Ia and Phase Ib: Progression Free Survival (PFS)		From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
Secondary	Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175		From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to treatment discontinuation (up to approximately 5 years)