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Trial record 1 of 1 for:    GO44431
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A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 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: NCT06031441
Recruitment Status : Recruiting
First Posted : September 11, 2023
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.

Condition or disease Intervention/treatment Phase
Locally Advanced Solid Tumors Recurrent Solid Tumors Metastatic Solid Tumors Drug: RO7566802 Drug: Atezolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : November 27, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation Cohort
Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 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: RO7566802
RO7566802 solution for infusion will be administered as specified in each treatment arm.

Drug: Atezolizumab
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Other Name: Tecentriq®

Experimental: Dose Expansion Cohort
Participants with select solid tumors will receive a recommended dose of RO7566802, determined in 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: RO7566802
RO7566802 solution for infusion will be administered as specified in each treatment arm.

Drug: Atezolizumab
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Other Name: Tecentriq®




Primary Outcome Measures :
  1. Number of Participants with DLTs [ Time Frame: Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days) ]
  2. Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) [ Time Frame: Up to approximately 39 months ]

Secondary Outcome Measures :
  1. Area Under the Serum Concentration Time Curve (AUC) of RO7566802 [ Time Frame: Up to approximately 39 months ]
  2. Maximum Serum Concentration (Cmax) of RO7566802 [ Time Frame: Up to approximately 39 months ]
  3. Minimum Serum Concentration (Cmin) of RO7566802 [ Time Frame: Up to approximately 39 months ]
  4. Total Clearance (CL) of RO7566802 [ Time Frame: Up to approximately 39 months ]
  5. Volume of Distribution at Steady State (Vss) of RO7566802 [ Time Frame: Up to approximately 39 months ]
  6. Serum Concentration of Atezolizumab [ Time Frame: Up to approximately 39 months ]
  7. Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: Up to approximately 39 months ]
  8. Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802 [ Time Frame: From Baseline up to approximately 39 months ]


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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:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Life expectancy >=3 months, in the investigator's judgment
  • Adequate hematologic and end-organ function
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
  • Measurable disease per RECIST v1.1
  • Disease that has progressed after at least one available standard therapy, and for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate, or for which a clinical trial of an investigational agent is a recognized standard of care
  • Tumor specimen availability, for certain cohorts

Exclusion Criteria:

  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions
  • Active hepatitis B or C
  • Active tuberculosis
  • Positive test for HIV infection
  • Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Active or history of autoimmune disease
  • Prior allogeneic stem cell or organ transplantation
  • Uncontrolled tumor-related pain
  • Significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria may apply.


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): NCT06031441


Contacts
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Contact: Reference Study ID Number: GO44431 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Australia, Victoria
Peter Maccallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT06031441    
Other Study ID Numbers: GO44431
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 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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Neoplasms
Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents