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A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

9. juli 2026 opdateret af: Genfleet Therapeutics (Shanghai) Inc.

A Multi-center, Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is an open-label, multicenter Phase Ib/II clinical trial to evaluate the safety, tolerability, and preliminary anti-tumor efficacy of oral GFH276 in combination with cetuximab or standard chemotherapy in adult patients with locally advanced or metastatic RAS-mutated solid tumors and pancreatic ductal adenocarcinoma (PDAC).

Participants will be enrolled into three treatment arms with different combination regimens.

In the Phase Ib stage, dose escalation of GFH276 will be performed in each combination arm to identify the optimal recommended Phase 2 dose (RP2D) based on dose-limiting toxicity (DLT) and the overall safety profile. After RP2D determination, Phase II expansion cohorts will enroll eligible patients 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

222

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Australien
    • New South Wales
      • Concord, New South Wales, Australien, 2139
        • Concord Cancer Centre, Concord Repatriation General Hospital, Sydney Local Health District
        • Kontakt:
          • Kim Tam B Bui, MBBS
      • North Ryde, New South Wales, Australien, 2109
        • Macquarie University / Clinical Trials Unit
        • Kontakt:
          • PhD
        • Kontakt:
          • Andrew Parsonson, PhD
    • South Australia
      • Woodville South, South Australia, Australien, 5011
        • The Queen Elizabeth Hospital
        • Kontakt:
          • Timothy Price, MBBS
    • Victoria
      • Clayton, Victoria, Australien, 3168
        • Monash Health (Monash Medical Centre)
      • Epping, Victoria, Australien, 3076
        • Northern Health
        • Kontakt:
          • Belinda Lee, MBBS
      • Frankston, Victoria, Australien, 3199
        • PASO Medical
        • Kontakt:
          • Vinod Ganju, MBBS
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100730
        • Peking Union Medical College Hospital
        • Kontakt:
          • Chunmei Bai, MD
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
        • Kontakt:
          • Zhihua Li, MD
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150081
        • The Third Affiliated Hospital (Cancer Hospital) of Harbin Medical University
        • Kontakt:
          • Guangyu Wang, MD
    • Henan
      • Zhengzhou, Henan, Kina, 450052
        • The First Affiliated Hospital of Zhengzhou University
        • Kontakt:
          • Hong Zong, MD
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:
          • Heshui Wu, MD
    • Liaoning
      • Shenyang, Liaoning, Kina, 110001
        • The First Affiliated Hospital of China Medical University
        • Kontakt:
          • Xiujuan Qu, MD
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710061
        • The First Affiliated Hospital of XI'an JiaoTong University
        • Kontakt:
          • Yinying Wu, MD
    • Shandong
      • Jinan, Shandong, Kina, 250117
        • Shandong First Medical University Affiliated Tumor Hospital
        • Kontakt:
          • Shuqin Ni, MD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Fudan University Shanghai Cancer Center
        • Kontakt:
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital of Sichuan University
        • Kontakt:
          • Xuelei Ma, MD
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Kontakt:
          • Da Li, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification
  3. At least one measurable lesion according to RECIST v1.1
  4. ECOG performance status 0 or 1
  5. Life expectancy > 3 months
  6. Adequate organ function
  7. Willing to provide written informed consent
  8. Fertile participants must use effective contraception

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. For participants with known concomitant second oncodriver for PDAC or for solid tumors.
  5. With active infection (HIV, HBV, HCV, syphilis)
  6. The presence of clinical or radiological evidence of intestinal obstruction.
  7. Prior anticancer therapy within 28 days or 5 half-lives
  8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months
  9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.
  10. History of central nervous system (CNS)disease
  11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.
  12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A: GFH276 + Cetuximab
GFH276 once daily; cetuximab 500 mg/m² intravenous infusion every 2 weeks.
Medicin: GFH276
Oral GFH276 administered once daily in combination with other study drugs.
Medicin: Cetuximab
Intravenous cetuximab at a dose of 500 mg/m²
Eksperimentel: Arm B: GFH276 + AG
GFH276 once daily; nab-paclitaxel 125 mg/m² + gemcitabine 1000 mg/m² (AG regimen); 4-week cycle (D1, D8, D15) or 3-week cycle (D1, D8) in China
Medicin: GFH276
Oral GFH276 administered once daily in combination with other study drugs.
Medicin: Nab paclitaxel
Intravenous nab-paclitaxel at a dose of 125 mg/m².
Medicin: Gemcitabine
Intravenous Gemcitabine at a dose of 1000 mg/m².
Eksperimentel: Arm C: GFH276 + mFOLFIRINOX

GFH276 once daily; mFOLFIRINOX :Fluorouracil 2400 mg/m²(46 h), Leucovorin 400 mg/m², Irinotecan 150 mg/m², Oxaliplatin 85 mg/m², IV D1, every 2 weeks .

The mFOLFIRINOX regimen may be administered per the above dosage, or in accordance with national or institutional guidelines.
Medicin: GFH276
Oral GFH276 administered once daily in combination with other study drugs.
Medicin: Fluorouracil
Intravenous Fluorouracil at a dose of 2400 mg/m² via 46-hour infusion.Dosing may follow the above regimen or local institutional standards.
Medicin: Leucovorin
Intravenous leucovorin at a dose of 400 mg/m².Dosing may follow the above regimen or local institutional standards.
Medicin: Irinotecan
Intravenous irinotecan at a dose of 150 mg/m².Dosing may follow the above regimen or local institutional standards.
Medicin: Oxaliplatin
Intravenous oxaliplatin at a dose of 85 mg/m².Dosing may follow the above regimen or local institutional standards.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events
Tidsramme: First 28 days (21 days for AG （3-week cycle）)
The incidence of DLT events
First 28 days (21 days for AG （3-week cycle）)
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 24 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 24 months
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 24 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 24 months
Phase Ib: Number of participants with abnormality in hematology laboratory parameters
Tidsramme: up to 24 months
Number of participants with abnormality in hematology laboratory parameters，Hematology assessments will include hemoglobin, white blood cell count, differential white blood cell counts and platelet count
up to 24 months
Phase Ib: Number of participants with abnormality in clinical chemistry laboratory assessments
Tidsramme: up to 24 months
Number of participants with abnormality in clinical chemistry laboratory assessments， assessments will include serum chemistry (such as sodium, potassium, urea, creatinine) and liver function parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin.
up to 24 months
Phase Ib: Number of participants with abnormality in body temperature
Tidsramme: up to 24 months
Number of participants with abnormality in body temperature(°C), throughout the study.
up to 24 months
Phase Ib: Number of participants with abnormality in blood pressure
Tidsramme: up to 24 months
Number of participants with abnormality in blood pressure, including systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
up to 24 months
Phase Ib: Number of participants with abnormality in Physical Examination Findings
Tidsramme: up to 24 months
Number of participants with abnormality in Physical Examination Findings
up to 24 months
Phase Ib: Number of participants with abnormality in PR interval
Tidsramme: up to 24 months
Number of participants with abnormality in electrocardiogram (ECG) parameters, including PR interval
up to 24 months
Phase Ib: Number of participants with abnormality in corrected QT interval using Frederica's formula (QTcF)
Tidsramme: up to 24 months
Number of participants with abnormality incorrected QT interval using Frederica's formula (QTcF)
up to 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
OS
Tidsramme: Fra første dosis indtil dødsdato af enhver årsag, vurderet op til 24 måneder
Overlevelse i alt
Fra første dosis indtil dødsdato af enhver årsag, vurderet op til 24 måneder
Phase II: Incidence and Severity of AE and SAE
Tidsramme: From the first dose until 30 days after the last dose, assessed up to 24 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 24 months
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 24 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 24 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 24 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 24 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 24 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 24 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 24 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 24 months
Time to peak plasma concentration（Tmax） of GFH276
Tidsramme: up to 6 months
Plasma concentrations of GFH276 and relevant pharmacokinetic parameters including Tmax were evaluated.
up to 6 months
Maximum plasma concentration of GFH276
Tidsramme: up to 6 months
Plasma concentrations of GFH276 and relevant pharmacokinetic parameters including Cmax were evaluated.
up to 6 months
Area Under the Curve from time zero to 24 hours of GFH276
Tidsramme: up to 6 months
Plasma concentrations of GFH276 and relevant pharmacokinetic parameters including AUC0-24 were evaluated.
up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genfleet Therapeutics (Shanghai) Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GFH276X0201

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