A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
Genentech, Inc.
Study ID
NCT06619587
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • Phase I Arm A — DRUG
    Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
  • Phase I Arm B — DRUG
    Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies

Study Details

This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.

Key Dates

Start date
Nov 14, 2024
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

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

Arms

  • Experimental: Phase I Arm A
    Dose escalation and expansion arm
  • Experimental: Phase I Arm B
    Dose escalation and expansion arm

Primary Outcome Measure

Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale [ Time Frame: 4 Years ]

Central Contacts

  • Reference Study ID Number: GO45416 https://forpatients.roche.com/
    888-662-6728 (U.S.)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (12)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-1503-
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Yale Cancer CenterNew HavenConnecticut06510-
Florida Cancer Specialist-Lake MaryLake MaryFlorida32746-
University of IllinoisChicagoIllinois60612-
Dana Farber Cancer InstituteBostonMassachusetts02215-
START - Midwest - EDOSGrand RapidsMichigan49546-7062-
Montefiore Einstein Cancer CenterThe BronxNew York10461-
Mary Crowley Medical Research CenterDallasPennsylvania75230-2571-
Abramson Cancer Center;Univ of PennsylvaniaPhiladelphiaPennsylvania19104-5127-
SCRI Oncology PartnersNashvilleTennessee37203-
O'Quinn Medical Tower at McNair CampusHoustonTexas77054-

Find similar trials in La Jolla, CA

By research site
UC San Diego Moores Cancer Center· La Jolla, CASarah Cannon Research Institute at HealthONE· Denver, COYale Cancer Center· New Haven, CTFlorida Cancer Specialist-Lake Mary· Lake Mary, FLUniversity of Illinois· Chicago, ILDana Farber Cancer Institute· Boston, MA

Related Studies