A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
Recruiting
Phase 1
Phase 2
Interventional Study
Advanced Solid Tumors Cancer
PDAC
CRC (Colorectal Cancer)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 126 (estimated)
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc. · Industry
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About This Trial
This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the e…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Voluntarily participate in the study and sign the informed consent form.
2. Participants receiving Regimen A must be ≥ 18 years old when signing the informed consent form, and participants receiving Arm B must be 18 - 75 years old.
3. Histologically or cytologically confirmed…
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