A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT06884618
Phase
PHASE1
Status
Recruiting
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Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • RO7673396 — DRUG
    RO7673396 will be administered as per the schedule specified in the protocol.

Study Details

This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s). This study consists of two stages: Stage 1 (Dose Escalation) and Stage 2 (Dose Expansion). Stage 1 will define the recommended dose(s) for expansion (RDEs) of RO7673396. Stage 2 will evaluate preliminary anti-tumor activity of the RDE(s) defined in Stage 1 and of other doses of interest for future development in selected solid tumor indications.

Key Dates

Start date
Apr 30, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
May 25, 2029

Study Design

Enrollment
405 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage I
    Participants with advanced solid tumors harboring RAS mutations will receive multiple ascending doses of RO7673396, as per a pre-defined dosing regimen until unacceptable toxicity or disease progression (PD) and/or loss of clinical benefit as determined by the investigator.
  • Experimental: Stage II
    Participants with advanced solid tumors harboring RAS mutations will receive RO7673396 at the dose determined in Stage 1, until unacceptable toxicity or PD and/or loss of clinical benefit as determined by the investigator.

Primary Outcome Measure

Stage I: Number of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 40 months ]

Central Contacts

  • Reference Study ID Number: YO45758 https://forpatients.roche.com/
    888-662-6728 (U.S.)
    [email protected]

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
University of Colorado - Anschutz Medical Campus - PPDSAuroraColorado80045-
Smilow Cancer Hospital at Yale New HavenNew HavenConnecticut06519-1110-
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)SarasotaFlorida34232-
MD Anderson Cancer CenterHoustonTexas77030-3721-
South Texas Accelerated Research Therapeutics (START)San AntonioTexas78229-4427-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity of Colorado - Anschutz Medical Campus - PPDS· Aurora, COSmilow Cancer Hospital at Yale New Haven· New Haven, CTFlorida Cancer Specialists - Sarasota (North Catttlemen Rd)· Sarasota, FLMD Anderson Cancer Center· Houston, TXSouth Texas Accelerated Research Therapeutics (START)· San Antonio, TX

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