Clinical Trials /

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

NCT04642365

Description:

This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: BP42595
  • SECONDARY ID: 2020-003164-82
  • NCT ID: NCT04642365

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
RO7296682Part I
AtezolizumabPart I

Purpose

This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
Part IExperimentalDose-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.
  • RO7296682
  • Atezolizumab
Part IIExperimentalDose-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.
  • RO7296682
  • Atezolizumab
Part III (Exploratory)ExperimentalDose-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.
  • RO7296682
  • Atezolizumab

Eligibility 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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants with Adverse Events (AEs)
Time Frame:Up to 31 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR) (Part I only)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Duration of Response (DoR)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Area under the Curve (AUC) of RO7296682
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Minimum Concentration (Cmin) of RO7296682
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Maximum Concentration (Cmax) of RO7296682
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Time of maximum concentration (Tmax) of RO7296682
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Volume of distribution at steady-state conditions (Vss) of RO7296682
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Half-life (t~1/2) of RO7296682
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Treatment-induced changes in Treg levels in blood and/or tumor as compared to baseline
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hoffmann-La Roche

Trial Keywords

  • RG6292

Last Updated

August 9, 2021