Health Trials

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

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Malabsorption or other condition that would interfere with enteral absorption

Active brain metastases

Clinically significant cardiovascular dysfunction or liver disease

Trial design

Treatments tested in this trial

  • Phase I Arm A
  • Phase I Arm B

Treatment groups

410 Participants
are divided into 2 treatment groups

Locations

41
Australia
St Vincent's Hospital Sydney2010, DarlinghurstNew South Wales, Australia
Slade Health Inward goods2080, Mount Kuring-GaiNew South Wales, Australia
Peter Maccallum Cancer Centre3052, ParkvilleVictoria, Australia
Canada
British Columbia Cancer AgencyV5Z 4E6, VancouverBritish Columbia, Canada

Sponsors and collaborators

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov