NCT07198321

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_1 cancer

Timeline
20mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

September 15, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 15, 2025

Last Update Submit

September 25, 2025

Conditions

CancerPDACCRC (Colorectal Cancer)NSCLC

Keywords

cancerRAS

Outcome Measures

Primary Outcomes (5)

  • Phase Ia:The incidence and severity of AEs and SAEs

    The incidence and severity of AEs and SAEs

    48 months

  • Phase Ia:The incidence of DLT events

    The incidence of DLT events

    21 days

  • Phase Ib:The incidence and severity of AEs and SAEs

    The incidence and severity of AEs and SAEs

    48 months

  • Phase II:Overall response rate (ORR)

    Aassessed by investigators according to RECIST 1.1

    about 48 months

  • Efficacy endpoints

    Duration of response (DoR)

    about 48 months

Secondary Outcomes (2)

  • Peak Plasma Concentration(Cmax)

    about 48 months

  • DCR

    about 48 months

Study Arms (1)

GFH276

EXPERIMENTAL

GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

Drug: GFH276

Interventions

GFH276DRUG

GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

GFH276

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun-Yat sen university cancer center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • li zhang, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

peng, PM

CONTACT

021-50781198ytpeng@genfleet.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 30, 2025

Study Start

September 22, 2025

Primary Completion (Estimated)

September 22, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)