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GFH276

Phase 2

RAS Mutation | Small molecule | Oncology |Intensity Therapeutics, Inc.|Last Updated: Sep 29, 2026

Development status

Highest phase Phase 2 run by Genfleet Therapeutics (Shanghai) Inc. (NCT07784374)
Phase scored for INTSPhase 1
Registered trials 2 across 1 sponsor since Aug 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

GFH276 · 1 trial · 2 indications

Phase 1 1
NCT07846358This is a Multicenter, Open-label, Phase I/II Study to Explore the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of GFH276 in Patients With Advanced NSCLC Harboring a RAS Mutation.RAS Mutation
NOT YET_RECRUITING84 Analytics
PHASE1NOT YET_RECRUITING
This is a Multicenter, Open-label, Phase I/II Study to Explore the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of GFH276 in Patients With Advanced NSCLC Harboring a RAS Mutation.
RAS Mutation
NCT0784635884
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Study Endpoints

Primary Endpoints

Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events
First 21 days

The incidence of DLT events

Phase II:Objective Response Rate (ORR)
From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Assessed by investigators according to RECIST 1.1

Phase Ib:Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)
From the first dose until 30 days after the last dose, assessed up to 36 months

The incidence and severity of AEs and SAEs，according to NCI CTCAE，v6.0

Secondary Endpoints

DCR
From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
DoR
From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
TTR
From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GFH276 ±Tislelizumab + APEXPERIMENTALGFH276 once daily; Tislelizumab 200 mg, IV; AP: Pemetrexed 500 mg/m², IV; Cisplatin/Carboplatin 75 mg/m²/AUC=5, IV, every 3 weeks

Interventions

NameTypeDescription
GFH276DRUGOral GFH276, administered at specified dose on schedule.
with or without TislelizumabDRUGTislelizumab 200 mg, intravenous infusion, once every 3 weeks.or without Tislelizumab
PemetrexedDRUGPemetrexed 500 mg/m², intravenous infusion, once every 3 weeks.
CisplatinDRUGCisplatin 75 mg/m², intravenous infusion, once every 3 weeks.
CarboplatinDRUGCarboplatin at AUC=5, intravenous infusion, once every 3 weeks.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Histologically/cytologically confirmed locally advanced or metastatic non squamous NSCLC (AJCC 8th edition Stage IIIB-IV). 2. Confirmed RAS mutation or KRAS amplification；tumor cell PD L1 test report available 3. No prior systemic anti-tumor therapy for advanced disease 4. At...

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Competitive Landscape -Genetic Mutations 6 trials (matched to "RAS Mutation")

Top 3 of 4 competitors

CompanyTickerTrialsLead PhaseDrugs
Tango Therapeutics, Inc.TNGX1PHASE1TNG462
Pasithea Therapeutics Corp.KTTA1PHASE1PAS-004
Adlai Nortye Ltd. Sponsored ADRANL1PHASE1AN9025
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Recent Changes (Last 90 Days)

LOWSep 29, 2026NCT07846358NEW_TRIAL: changed
LOWSep 29, 2026NCT07846358NEW_TRIAL: changed

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