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Recruiting NCT06619587

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

Phase I Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phase I Arm A, Phase I Arm B.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, France, Israel +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation

Overview

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.

Interventions

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

Primary outcome measures

  • Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale [Time frame: 4 Years]
  • Percentage of Participants with Dose Limiting Toxicity [Time frame: 4 Years]
Secondary outcome measures (7)
  • Plasma Concentrations of GDC-7035 at Specified Timepoints [Time frame: 4 Years]
  • Blood Concentrations of GDC-7035 at Specified Timepoints [Time frame: 4 Years]
  • Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal [Time frame: 4 Years]
  • Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal [Time frame: 4 Years]
  • Objective Response Rate Among Participants [Time frame: 4 Years]
  • Duration of Response Among Participants [Time frame: 4 Years]
  • Median Progression Free Survival Time Among Participants [Time frame: 4 Years]

Eligibility criteria

Inclusion criteria

  • Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
  • Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

Exclusion criteria

  • Malabsorption or other condition that would interfere with enteral absorption
  • Active brain metastases
  • Clinically significant cardiovascular dysfunction or liver disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • UC San Diego Moores Cancer Center — La Jolla
  • Sarah Cannon Research Institute at HealthONE — Denver
  • Yale Cancer Center — New Haven
  • Florida Cancer Specialist-Lake Mary — Lake Mary
  • University of Illinois — Chicago
  • Dana Farber Cancer Institute — Boston
  • START - Midwest - EDOS — Grand Rapids
  • Montefiore Einstein Cancer Center — The Bronx
  • … and 4 more centers
Spain · 6 centers
  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona
  • Hospital Universitario 12 de Octubre — Madrid
  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC — Madrid
  • Hospital Universitario Virgen de la Victoria — Málaga
  • Hospital Universitario Virgen del Rocio - PPDS — Seville
  • Hospital Clinico Universitario de Valencia — Valencia
Israel · 4 centers
  • Rambam Health Care Campus — Haifa
  • Hadassah University Hospital - Ein Kerem — Jerusalem
  • The Chaim Sheba Medical Center — Ramat Gan
  • Tel Aviv Sourasky Medical Center PPDS — Tel Aviv
South Korea · 4 centers
  • Seoul National University Bundang Hospital — Seongnam
  • Asan Medical Center. — Seoul
  • Seoul National University Hospital — Seoul
  • Severance Hospital, Yonsei University Health System — Seoul
United Kingdom · 4 centers
  • Western General Hospital;Edinburgh Cancer Center — Edinburgh
  • NIHR UCLH Clinical Research Facility — London
  • The Christie — Manchester
  • Royal Marsden Hospital - Surrey — Sutton
Australia · 3 centers
  • St Vincent's Hospital Sydney — Darlinghurst
  • Slade Health Inward goods — Mount Kuring-Gai
  • Peter Maccallum Cancer Centre — Parkville
Canada · 3 centers
  • British Columbia Cancer Agency — Vancouver
  • Princess Margaret Cancer Centre — Toronto
  • Sir Mortimer B Davis Jewish General Hospital — Montreal
France · 3 centers
  • Gustave Roussy — Villejuif
  • Institut Bergonie — Bordeaux
  • Centre Georges Francois Leclerc — Dijon
Singapore · 2 centers
  • National University Hospital — Singapore
  • National Cancer Centre — Singapore

Identifiers

NCT: NCT06619587 · GO45416

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗