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Trial record 1 of 1 for:    NCT04642365
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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 : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: RO7296682 Drug: Atezolizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 31 months ]
  2. Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 31 months ]
  3. Objective Response Rate (ORR) (Part II and III only) [ Time Frame: Up to 31 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) (Part I only) [ Time Frame: Up to 31 months ]
  2. Disease Control Rate (DCR) [ Time Frame: Up to 31 months ]
  3. Duration of Response (DoR) [ Time Frame: Up to 31 months ]
  4. Progression-Free Survival (PFS) [ Time Frame: Up to 31 months ]
  5. Overall Survival (OS) [ Time Frame: Up to 31 months ]
  6. Area under the Curve (AUC) of RO7296682 [ Time Frame: Up to 31 months ]
  7. Minimum Concentration (Cmin) of RO7296682 [ Time Frame: Up to 31 months ]
  8. Maximum Concentration (Cmax) of RO7296682 [ Time Frame: Up to 31 months ]
  9. Time of maximum concentration (Tmax) of RO7296682 [ Time Frame: Up to 31 months ]
  10. Volume of distribution at steady-state conditions (Vss) of RO7296682 [ Time Frame: Up to 31 months ]
  11. Half-life (t~1/2) of RO7296682 [ Time Frame: Up to 31 months ]
  12. Treatment-induced changes in Treg levels in blood and/or tumor as compared to baseline [ Time Frame: Up to 31 months ]
  13. Treatment-induced changes in Teff/Treg (T-effector cell; T-regulatory cell) ratio in blood and/or tumor as compared to baseline [ Time Frame: Up to 31 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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:

- 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).
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): NCT04642365


Contacts
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Contact: Reference Study ID Number: BP42595 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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United States, California
City of Hope Cancer Center Withdrawn
Duarte, California, United States, 91010
United States, Texas
MD Anderson Cancer Center Terminated
Houston, Texas, United States, 77030
Australia, Victoria
Peter Maccallum Cancer Institute; Clinical Trial Unit Active, not recruiting
Melbourne, Victoria, Australia, 3000
Belgium
Cliniques Universitaires St-Luc Active, not recruiting
Bruxelles, Belgium, 1200
Canada, British Columbia
BC Cancer Agency - Vancouver Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
The Ottawa Hospital Cancer Centre Completed
Ottawa, Ontario, Canada, K2H 6C2
Princess Margaret Cancer Centre Active, not recruiting
Toronto, Ontario, Canada, M5G 1Z5
Denmark
Rigshospitalet; Onkologisk Klinik Recruiting
København Ø, Denmark, 2100
Spain
Clinica Universitaria de Navarra Active, not recruiting
Pamplona, Navarra, Spain, 31008
Vall d?Hebron Institute of Oncology (VHIO), Barcelona Completed
Barcelona, Spain, 08035
Fundacion Jimenez Diaz; Servicio de Oncologia Active, not recruiting
Madrid, Spain, 28040
Centro Integral Oncologico Clara Campal; Servicio de Oncología Active, not recruiting
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia Completed
Valencia, Spain, 46010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04642365    
Other Study ID Numbers: BP42595
2020-003164-82 ( EudraCT Number )
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
RG6292
Additional relevant MeSH terms:
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Neoplasms
Atezolizumab
Immune Checkpoint Inhibitors
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents