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.
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
Interventions
Drug | Synonyms | Arms |
---|
RO7296682 | | Part I |
Atezolizumab | | Part 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
Name | Type | Description | Interventions |
---|
Part I | Experimental | 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. | |
Part II | Experimental | 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. | |
Part III (Exploratory) | Experimental | 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. | |
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
Last Updated
August 9, 2021