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

• ClinicalTrials.gov Identifier: NCT05581004
• Recruitment Status: Recruiting
• First Posted: October 14, 2022
• Last Update Posted: May 17, 2024
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: October 12, 2022
• First Posted Date: October 14, 2022
• Last Update Posted Date: May 17, 2024
• Actual Study Start Date: October 20, 2022
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 12, 2022)

• 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) ]
• 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) ]
• Phase Ia: Number of Participants with Treatment Emergent Adverse Events [ Time Frame: Up to approximately 5 years ]
• Phase Ib: Number of Participants with Treatment Emergent Adverse Events [ Time Frame: Up to approximately 5 years ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 12, 2022)

• 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) ]
• 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) ]
• 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) ]
• 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) ]
• 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) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• 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.

Study Arms

• 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.
  Intervention: Drug: RO7502175
• 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.
  Intervention: Drug: RO7502175
• 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.
  Interventions:

  • Drug: RO7502175
  • Drug: Atezolizumab
• 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.
  Interventions:

  • Drug: RO7502175
  • Drug: Atezolizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 19, 2024): 395
• Original Estimated Enrollment (submitted: October 12, 2022): 365
• Estimated Study Completion Date: October 31, 2025
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Reference Study ID Number: GO43860 https://forpatients.roche.com/; 888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

• Listed Location Countries: Australia, Belgium, Canada, Korea, Republic of, Netherlands, Spain, United States

Administrative Information

• NCT Number: NCT05581004
• Other Study ID Numbers: GO43860; 2021-006708-34 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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).

• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Genentech, Inc.
• Verification Date: May 2024