A Phase 1 Study of RO7623066 Alone and in Combination in Patients With Advanced Solid Tumors

Part of paid clinical trials in Orange, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05240898
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7623066 — DRUG
    Administered orally in capsule
  • Olaparib — DRUG
    Administered orally. Dose levels and schedules will be selected based on integration of preclinical data as well as clinical PK, safety, efficacy, and PD/biomarker data (as appropriate) from the dose escalation cohorts.
  • Carboplatin — DRUG
    Administered intravenously.

Study Details

This is a Phase 1 study to assess the safety and clinical activity of RO7623066 alone and in combination in patients with advanced solid tumors.

Key Dates

Start date
Aug 26, 2021
Status verified
Dec 2025
Primary completion
Nov 26, 2025
Completion
Nov 26, 2025

Study Design

Enrollment
116 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: RO7623066 Monotherapy (Dose Escalation)
    RO7623066 will be administered orally once daily (QD) continuously as monotherapy. Once the maximum tolerated dose (MTD) for RO7623066 monotherapy has been reached this concludes the Dose Escalation phase.
  • Experimental: RO7623066 + Olaparib (Dose Escalation and Expansion)
    RO7623066 will be tested in combination with olaparib. Escalating dose levels will be tested until the maximum tolerated dose (MTD), or lower, of RO7623066 is reached or MTD, or lower, of the combination is reached (whichever occurs first). Combination arms can enroll concurrently. Olaparib will be dosed per standard of care (SoC).
  • Experimental: RO7623066 + Carboplatin (Dose Escalation and Expansion)
    RO7623066 will be tested in combination with carboplatin. Escalating dose levels will be tested until the maximum tolerated dose (MTD), or lower, of RO7623066 is reached or MTD, or lower, of the combination is reached (whichever occurs first). Combination arms can enroll concurrently. Carboplatin will be dosed per standard of care (SoC).
  • Other: RO7623066 + Olaparib Backfill Cohort
    Once safety data has been obtained in the RO7623066 + Olaparib arm during the dose escalation phase, Backfill cohorts will be used to determine the Recommended Dose for Expansion of RO7623066 + Olaparib.
  • Other: RO7623066 Food Effect Cohort
    The effect of food intake on the PK of RO7623066 will be explored at a dose close to the Maximum Tolerated Dose (MTD) and/or at Recommended Phase II Dose (RP2D) or at a relevant dose level for a minimum of 12 participants that have at least one tumor mutation of interest.

Primary Outcome Measure

The Maximum Tolerated Dose (MTD) Measured by the Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Approximately 4 years 10 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
University of California Irvine Medical CenterOrangeCalifornia92868-
Yale School of MedicineNew HavenConnecticut06510-3206-
Barbara Ann Karmanos Cancer InstituteDetroitMaine48201-2013-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
South Texas Accelerated Research Therapeutics (START) - Midwest LocationGrand RapidsMichigan49546-
Hackensack University Medical CenterHackensackNew Jersey07601-
Cleveland Clinic,ClevelandOhio44195-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Oregon Health & Science UniversityPortlandOregon97239-
Rhode Island HospitalProvidenceRhode Island02906-
Mary Crowley Medical Research CenterDallasTexas75230-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-
South Texas Accelerated Research Therapeutics (START)San AntonioTexas98229-
University of Virginia Health SystemCharlottesvilleVirginia22908-

Find similar trials in Orange, CA

By research site
University of California Irvine Medical Center· Orange, CAYale School of Medicine· New Haven, CTBarbara Ann Karmanos Cancer Institute· Detroit, MEDana-Farber Cancer Institute· Boston, MASouth Texas Accelerated Research Therapeutics (START) - Midwest Location· Grand Rapids, MIHackensack University Medical Center· Hackensack, NJ

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