A Phase 1/2 interventional study of GFH276 and with or without Tislelizumab in RAS Mutation and Non-small Cell Lung Cancer (NSCLC), sponsored by Genfleet Therapeutics (Shanghai) Inc.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Genfleet Therapeutics (Shanghai) Inc. · Phase 1/2, Interventional, and Treatment
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.
This open-label, multicenter Phase Ib/II study enrolls participants with locally advanced or metastatic non-squamous NSCLC with RAS mutation or KRAS amplification, who have not received prior systemic anti-cancer therapy for advanced disease.
In Phase Ib, dose escalation of GFH276 will be performed in assigned arm to identify the recommended Phase 2 dose (RP2D) based on dose-limiting toxicity (DLT) and the overall safety profile. After RP2D determination, participants will be enrolled in Phase II to further evaluate the anti-tumor efficacy and long-term safety of each combination regimen. Study-related assessments will include tumor imaging, laboratory tests, adverse event monitoring, and pharmacokinetic sampling throughout the treatment period.
Participants will continue their assigned study treatment until confirmed disease progression, intolerable toxicity, withdrawal of consent, or study closure.
Exclusion Criteria:
GFH276 once daily; Tislelizumab 200 mg, IV; AP: Pemetrexed 500 mg/m², IV; Cisplatin/Carboplatin 75 mg/m²/AUC=5, IV, every 3 weeks
Drug: GFH276 · Drug: with or without Tislelizumab · Drug: Pemetrexed · Drug: Cisplatin · Drug: Carboplatin
Oral GFH276, administered at specified dose on schedule.
Tislelizumab 200 mg, intravenous infusion, once every 3 weeks.or without Tislelizumab
Pemetrexed 500 mg/m², intravenous infusion, once every 3 weeks.
Cisplatin 75 mg/m², intravenous infusion, once every 3 weeks.
Carboplatin at AUC=5, intravenous infusion, once every 3 weeks.
Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events
The incidence of DLT events
Time frame: First 21 days
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
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
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
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
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
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
OS
Overall Survival
Time frame: From the first dose until date of death from any cause, assessed up to 36 months
Phase II: Incidence and Severity of AE and SAE
Incidence and Severity of AE and SAE，Assessed according to CTCAE 6.0
Time frame: From the first dose until 30 days after the last dose, assessed up to 36 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Genfleet Therapeutics (Shanghai) Inc.