A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GFH276.
- Who it may be relevant to
- Registry conditions: Cancer, PDAC, CRC (Colorectal Cancer), NSCLC. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study
Overview
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.
Interventions
- Drug GFH276
GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Primary outcome measures
- Phase Ia:The incidence and severity of AEs and SAEs [Time frame: 48 months]
- Phase Ia:The incidence of DLT events [Time frame: 21 days]
- Phase Ib:The incidence and severity of AEs and SAEs [Time frame: 48 months]
- Phase II:Overall response rate (ORR) [Time frame: about 48 months]
- Efficacy endpoints [Time frame: about 48 months]
Secondary outcome measures (2)
- Peak Plasma Concentration(Cmax) [Time frame: about 48 months]
- DCR [Time frame: about 48 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Active brain metastases.
- Prior treatment with a PAN-RAS inhibitor.
- Palliative radiotherapy was completed within 14 days before the first dose.
- 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.
- Pregnant or lactating women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun-Yat sen university cancer center — Guangzhou
Identifiers
NCT: NCT07198321 · GFH276X1101