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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 Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: GO43860
  • Secondary ID: 2021-006708-34
  • NTC 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 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.

  • Overall Status
    Recruiting
  • Start Date
    October 31, 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
  • 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 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

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: N/A

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

Email: global-roche-genentech-trials@gene.com

LOCATION

Facility Status Contact
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: SCRI Tennessee Oncology Nashville
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A