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Trial Title:
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
NCT ID:
NCT06619587
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Phase I Arm A
Description:
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
Arm group label:
Phase I Arm A
Intervention type:
Drug
Intervention name:
Phase I Arm B
Description:
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in
combination with other anti-cancer therapies
Arm group label:
Phase I Arm B
Summary:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 22, 2024
Completion date:
November 30, 2028
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06619587
