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.
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
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.
Single group
GFH276
DrugGFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Phase Ia:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Phase Ia:The incidence of DLT events
The incidence of DLT events
Phase Ib:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Phase II:Overall response rate (ORR)
Aassessed by investigators according to RECIST 1.1
Peak Plasma Concentration(Cmax)
DCR
he percentage of patients who achieved CR, PR and SD
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
