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Brief Title: RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

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 Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: GO43860
  • Secondary ID: N/A
  • NCT ID: NCT05581004
  • Sponsor: Genentech, Inc.

BRIEF 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 or pembrolizumab 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, colorectal cancer (CRC), 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.

  • Overall Status
    Recruiting
  • Start Date
    October 20, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)

Primary Outcome 1 - Timeframe: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)

Primary Outcome 2 - Measure: Phase Ib: Number of Participants with DLTs

Primary Outcome 2 - Timeframe: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)

Primary Outcome 3 - Measure: Phase Ia: Number of Participants with Treatment Emergent Adverse Events

Primary Outcome 3 - Timeframe: Up to approximately 5 years

Primary Outcome 4 - Measure: Phase Ib: Number of Participants with Treatment Emergent Adverse Events

Primary Outcome 4 - Timeframe: Up to approximately 5 years

CONDITION

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

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 intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab

- * 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Reference Study ID Number: GO43860 https://forpatients.roche.com/

Phone: 888-662-6728 (U.S. Only)

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Stanford University'
San Francisco, California 94305
United States
Status: Recruiting Contact: N/A
Facility: University Of Colorado
Aurora, Colorado 80045
United States
Status: Recruiting Contact: N/A
Facility: Florida Cancer Specialists - Sarasota
Sarasota, Florida 34232
United States
Status: Recruiting Contact: N/A
Facility: Winship Cancer Institute
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: N/A
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: N/A
Facility: Henry Ford Hospital
Detroit, Michigan 48202
United States
Status: Recruiting Contact: N/A
Facility: Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
Status: Recruiting Contact: N/A
Facility: The West Clinic - Memphis (Union Ave)
Germantown, Tennessee 38138
United States
Status: Recruiting Contact: N/A
Facility: SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas 98229
United States
Status: Recruiting Contact: N/A