At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study
In Brief
A Phase 2 clinical trial evaluating GFH276 for Cancer and 3 related conditions. Not yet recruiting, targeting 450 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.