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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. (GFH276X1203)

22. september 2026 oppdatert av: Genfleet Therapeutics (Shanghai) Inc.

A Phase Ib/II, Multicenter, Open-Label Study To Evaluate Safety, Efficacy And Pharmacokinetics Of GFH276 In Combination With Tislelizumab, Pemetrexed And Platinum (Carboplatin Or Cisplatin) As First-Line Therapy In Participants With Locally Advanced Or Metastatic Non-Squamous Non-Small-Cell Lung Cancer Harboring RAS Mutation

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

84

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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 least 1 measurable lesion outside the central nervous system (CNS) per RECIST v1.1
  5. ECOG performance status 0 or 1
  6. Life expectancy>3 months
  7. Willing to provide written informed consent
  8. Fertile participants must use effective contraception
  9. Adequate organ function

Exclusion Criteria:

  1. Other active malignancy within 3 years
  2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor
  3. History of active clinically significant cardiovascular dysfunction
  4. Known to harbor other targetable driver gene alterations
  5. Presence of active infection (HIV, HBV, HCV,)
  6. Prior anti-tumor therapy within 28 days or 5 half-lives
  7. Diagnosis of unstable thrombotic events requiring therapeutic intervention within 3 months prior to the first dose of study treatment.
  8. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.
  9. History of central nervous system (CNS)disease
  10. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.
  11. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
  12. Active autoimmune disease requiring systemic treatment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: GFH276 ±Tislelizumab + AP

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

Oral GFH276, administered at specified dose on schedule.

Legemiddel: with or without Tislelizumab

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

Legemiddel: Pemetrexed

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

Legemiddel: Cisplatin

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

Legemiddel: Carboplatin

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

Hva måler studien?

Primære resultatmål

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

The incidence of DLT events
First 21 days
Phase II:Objective Response Rate (ORR)
Tidsramme: 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
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)
Tidsramme: 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
From the first dose until 30 days after the last dose, assessed up to 36 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
DCR
Tidsramme: 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

Disease Control Rate (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
Tidsramme: 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

Duration of Response assessed by investigators
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
Tidsramme: 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

Time To Response assessed by investigators
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
Tidsramme: 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

Progression-Free Survival (PFS) per Response Evaluation Criteria according to RECIST 1.1, as Determined by investigators
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
Tidsramme: From the first dose until date of death from any cause, assessed up to 36 months

Overall Survival
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
Tidsramme: From the first dose until 30 days after the last dose, assessed up to 36 months

Incidence and Severity of AE and SAE，Assessed according to CTCAE 6.0
From the first dose until 30 days after the last dose, assessed up to 36 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Genfleet Therapeutics (Shanghai) Inc.

Etterforskere

  • Hovedetterforsker: Ziming Li, MD, Shanghai Chest Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

22. september 2026

Først innsendt som oppfylte QC-kriteriene

22. september 2026

Først lagt ut (Faktiske)

29. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GFH276X1203

Plan for individuelle deltakerdata (IPD)

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Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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