NCT07198321Not yet recruitingPhase 1/2
A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors
A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study
Source: ClinicalTrials.gov · Last updated 30 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is an investigation to evaluate the safety/tolerability, pharmacokinetics (PK), and efficacy of GFH276 as a single agent in patients with advanced solid tumors harboring RAS mutations. The primary objectives of the Phase I study are to assess the safety/tolerability, PK, and preliminary efficacy of GFH276 in patients with advanced solid tumors harboring RAS mutations, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of GFH276. The primary objective of the Phase II study is to evaluate the efficacy of GFH276 in patients with RAS-mutant advanced pancreatic ductal adenocarcinoma (PDAC), advanced non-small cell lung cancer (NSCLC), advanced colorectal cancer (CRC), and other advanced solid tumors.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 22 Sept 2025
- Primary completion date
- 22 Sept 2027
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT07198321
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 450
- From 22 Sept 2025 to the primary completion date, 22 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with a PAN-RAS inhibitor.
- Palliative radiotherapy was completed within 14 days before the first dose.
Other illness
- Have poorly controlled or severe cardiovascular disease.
- Subjects with active hepatitis B or active hepatitis C.
- Known allergy to the study drug or its components.
Other
- Active brain metastases.
- Pregnant or lactating women.
Who the study is looking for
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- Male or female ≥ 18 years old and ≤75 years old.
- ECOG performance status of 0-1.
- With a life expectancy of ≥3 moths
- Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
- Adequate laboratory parameters during the screening period.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.