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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.

ConditionsRAS MutationNon-small Cell Lung Cancer (NSCLC)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGenfleet Therapeutics (Shanghai) Inc.

About this trial

This is an open-label, multicenter Phase Ib/II clinical study evaluating GFH276 in combination with tislelizumab plus pemetrexed/platinum based regimen as first-line therapy in participants with locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) harboring RAS mutation or KRAS amplification.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically/cytologically confirmed locally advanced or metastatic non squamous NSCLC (AJCC 8th edition Stage IIIB-IV).

Confirmed RAS mutation or KRAS amplification；tumor cell PD L1 test report available

No prior systemic anti-tumor therapy for advanced disease

At least 1 measurable lesion outside the central nervous system (CNS) per RECIST v1.1

Disqualifiers

Other active malignancy within 3 years

Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor

History of active clinically significant cardiovascular dysfunction

Known to harbor other targetable driver gene alterations

Trial design

Design model

Single group

Treatments tested in this trial

  • GFH276

    Drug

    Oral GFH276, administered at specified dose on schedule.

  • with or without Tislelizumab

    Drug

    Tislelizumab 200 mg, intravenous infusion, once every 3 weeks.or without Tislelizumab

  • Pemetrexed

    Drug

    Pemetrexed 500 mg/m², intravenous infusion, once every 3 weeks.

  • Cisplatin

    Drug

    Cisplatin 75 mg/m², intravenous infusion, once every 3 weeks.

  • Carboplatin

    Drug

    Carboplatin at AUC=5, intravenous infusion, once every 3 weeks.

Treatment groups

84 Participants
are divided into 1 treatment group
Group A: GFH276 ±Tislelizumab + APExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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

The incidence of DLT events

Time frame
First 21 days
2

Phase II:Objective Response Rate (ORR)

Assessed by investigators according to RECIST 1.1

Time frame
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
3

Phase Ib:Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)

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

Time frame
From the first dose until 30 days after the last dose, assessed up to 36 months

Secondary outcomes

1

DCR

Disease Control Rate (DCR)

Time frame
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
2

DoR

Duration of Response assessed by investigators

Time frame
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
3

TTR

Time To Response assessed by investigators

Time frame
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
4

PFS

Progression-Free Survival (PFS) per Response Evaluation Criteria according to RECIST 1.1, as Determined by investigators

Time frame
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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genfleet Therapeutics (Shanghai) Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: