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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

410 Participants
are divided into 2 treatment groups
Group A: Phase I Arm AExperimental treatment 1 intervention
Group B: Phase I Arm BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale

Time frame
4 Years
2

Percentage of Participants with Dose Limiting Toxicity

Time frame
4 Years

Secondary outcomes

1

Plasma Concentrations of GDC-7035 at Specified Timepoints

Time frame
4 Years
2

Blood Concentrations of GDC-7035 at Specified Timepoints

Time frame
4 Years
3

Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal

Time frame
4 Years
4

Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal

Time frame
4 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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