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A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.

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ClinicalTrials.gov Identifier: NCT04642365
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE November 24, 2020
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE January 4, 2021
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 31 months ]
  • Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 31 months ]
  • Objective Response Rate (ORR) (Part II and III only) [ Time Frame: Up to 31 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • Objective Response Rate (ORR) (Part I only) [ Time Frame: Up to 31 months ]
  • Disease Control Rate (DCR) [ Time Frame: Up to 31 months ]
  • Duration of Response (DoR) [ Time Frame: Up to 31 months ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to 31 months ]
  • Overall Survival (OS) [ Time Frame: Up to 31 months ]
  • Area under the Curve (AUC) of RO7296682 [ Time Frame: Up to 31 months ]
  • Minimum Concentration (Cmin) of RO7296682 [ Time Frame: Up to 31 months ]
  • Maximum Concentration (Cmax) of RO7296682 [ Time Frame: Up to 31 months ]
  • Time of maximum concentration (Tmax) of RO7296682 [ Time Frame: Up to 31 months ]
  • Volume of distribution at steady-state conditions (Vss) of RO7296682 [ Time Frame: Up to 31 months ]
  • Half-life (t~1/2) of RO7296682 [ Time Frame: Up to 31 months ]
  • Treatment-induced changes in Treg levels in blood and/or tumor as compared to baseline [ Time Frame: Up to 31 months ]
  • Treatment-induced changes in Treg/Teff (T-regulatory cell; T-effector cell) ratio in blood and/or tumor as compared to baseline [ Time Frame: Up to 31 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
Official Title  ICMJE An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7296682 in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
Brief Summary This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • Drug: RO7296682
    RO7296682 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  ICMJE
  • Experimental: Part I
    Dose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682 with a fixed dose of Atezolizumab, every three weeks (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined.
    Interventions:
    • Drug: RO7296682
    • Drug: Atezolizumab
  • Experimental: Part II
    Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I. Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab.
    Interventions:
    • Drug: RO7296682
    • Drug: Atezolizumab
  • Experimental: Part III (Exploratory)
    Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I and if clinical activity is seen in this trial or in the single agent study (WP41188). Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab at the dosing regimen established in Part I.
    Interventions:
    • Drug: RO7296682
    • Drug: Atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Diagnosis of advanced and/or metastatic solid tumors who have progressed on a standard therapy, are intolerant to standard of care (SoC), and/or and non-amenable to SoC.

Participants whose tumors have known sensitizing mutations must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.

  • Measurable disease according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Able to provide the most recent archival tumor tissue samples.
  • Adequate cardiovascular, haematological, liver and renal function.
  • Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen.
  • Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
  • Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.

Exclusion Criteria:

  • Pregnancy, lactation, or breastfeeding.
  • Known hypersensitivity to any of the components of RO7296682 and atezolizumab, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
  • History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
  • Participants with another invasive malignancy in the last two years.
  • Participants with known active or uncontrolled infection.
  • Positive HIV test at screening.
  • Positive for Hepatitis B and C.
  • Vaccination with live vaccines within 28 days prior to C1D1.
  • Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 and atezolizumab infusion.
  • Participants with wound healing complications.
  • Dementia or altered mental status that would prohibit informed consent.
  • History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms).
  • Active or history of autoimmune disease or immune deficiency.
  • Prior treatment with CPIs (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved.
  • Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1.
  • Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: BP42595 http://www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Denmark,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04642365
Other Study ID Numbers  ICMJE BP42595
2020-003164-82 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
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  ICMJE
Plan to Share IPD: No
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).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP