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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

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ClinicalTrials.gov Identifier: NCT05581004
Recruitment Status : Recruiting
First Posted : October 14, 2022
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Solid Tumors NSCLC HNSCC Melanoma TNBC Esophageal Cancer Gastric Cancer Cervical Cancer Urothelial Carcinoma Clear Cell RCC HCC Drug: RO7502175 Drug: Atezolizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 395 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 20, 2022
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : October 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Phase Ia: Number of Participants with Treatment Emergent Adverse Events [ Time Frame: Up to approximately 5 years ]
  4. Phase Ib: Number of Participants with Treatment Emergent Adverse Events [ Time Frame: Up to approximately 5 years ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05581004


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

Locations
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Sponsors and Collaborators
Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT05581004    
Other Study ID Numbers: GO43860
2021-006708-34 ( EudraCT Number )
First Posted: October 14, 2022    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents