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

April 19, 2024 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

395

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • Kinghorn Cancer Centre; St Vincents Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health Monash Medical Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Linear Clinical Research Ltd
  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • UZ Antwerpen
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège
      • Wilrijk, Belgium, 2610
        • Recruiting
        • GasthuisZusters Antwerpen
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • British Columbia Cancer Agency
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8M2
        • Recruiting
        • Ottawa Hospital Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Sir Mortimer B Davis Jewish General Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center - PPDS
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center - PPDS
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Universitair Medisch Centrum Groningen
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28040
        • Recruiting
        • START MADRID_Hospital Universiario Fundacion Jimenez Diaz
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
    • Barcelona
      • L?Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • ICO l?Hospitalet ? Hospital Duran i Reynals
  • United States
    • California
      • San Francisco, California, United States, 94305
        • Recruiting
        • Stanford University'
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists - Sarasota
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Medical Center, Division of Oncology
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic - Memphis (Union Ave)
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • San Antonio, Texas, United States, 98229
        • Recruiting
        • South Texas Accelerated Research Therapeutics (START)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase Ia: Dose Escalation
Participants in successive cohorts will receive escalating doses of RO7502175, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Drug: RO7502175
RO7502175 will be administered as per the schedules specified in the respective arms.
Experimental: Phase Ia: Expansion
Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Drug: RO7502175
RO7502175 will be administered as per the schedules specified in the respective arms.
Experimental: Phase Ib: Dose Escalation
Participants in successive cohorts will receive escalating doses of RO7502175, 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: RO7502175
RO7502175 will be administered as per the schedules specified in the respective arms.
Drug: Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Experimental: Phase Ib: Expansion
Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ib 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: RO7502175
RO7502175 will be administered as per the schedules specified in the respective arms.
Drug: Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
Phase Ib: Number of Participants with DLTs
Time Frame: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
Phase Ia: Number of Participants with Treatment Emergent Adverse Events
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Phase Ib: Number of Participants with Treatment Emergent Adverse Events
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175
Time Frame: From Cycle 1 (each cycle is 21 days) Day1 and at multiple timepoints up to each follow-up visits (up to approximately 5 years)
From Cycle 1 (each cycle is 21 days) Day1 and at multiple timepoints up to each follow-up visits (up to approximately 5 years)
Phase Ia and Phase Ib: Objective Response Rate (ORR)
Time Frame: From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
Phase Ia and Phase Ib: Duration of Response (DOR)
Time Frame: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
Phase Ia and Phase Ib: Progression Free Survival (PFS)
Time Frame: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175
Time Frame: From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to treatment discontinuation (up to approximately 5 years)
From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to treatment discontinuation (up to approximately 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2022

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO43860
  • 2021-006708-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe