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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

ConditionsAdvanced Solid Tumors CancerPancreatic Ductal AdenocarcinomaRAS Mutation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenfleet Therapeutics (Shanghai) Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification

At least one measurable lesion according to RECIST v1.1

ECOG performance status 0 or 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

For participants with known concomitant second oncodriver for PDAC or for solid tumors.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GFH276

    Drug

    Oral GFH276 administered once daily in combination with other study drugs.

  • Cetuximab

    Drug

    Intravenous cetuximab at a dose of 500 mg/m²

  • Nab paclitaxel

    Drug

    Intravenous nab-paclitaxel at a dose of 125 mg/m².

  • Gemcitabine

    Drug

    Intravenous Gemcitabine at a dose of 1000 mg/m².

  • Fluorouracil

    Drug

    Intravenous Fluorouracil at a dose of 2400 mg/m² via 46-hour infusion.Dosing may follow the above regimen or local institutional standards.

  • Leucovorin

    Drug

    Intravenous leucovorin at a dose of 400 mg/m².Dosing may follow the above regimen or local institutional standards.

  • Irinotecan

    Drug

    Intravenous irinotecan at a dose of 150 mg/m².Dosing may follow the above regimen or local institutional standards.

  • Oxaliplatin

    Drug

    Intravenous oxaliplatin at a dose of 85 mg/m².Dosing may follow the above regimen or local institutional standards.

Treatment groups

222 Participants
are divided into 3 treatment groups
Group A: Arm A: GFH276 + CetuximabExperimental treatment 2 interventions
Group B: Arm B: GFH276 + AGExperimental treatment 3 interventions
Group C: Arm C: GFH276 + mFOLFIRINOXExperimental 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 28 days (21 days for AG （3-week cycle）)
2

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 24 months
3

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 24 months
4

Phase Ib: Number of participants with abnormality in hematology laboratory parameters

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

Time frame
up to 24 months

Secondary outcomes

1

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 24 months
2

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 24 months
3

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 24 months
4

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 24 months

Other outcomes

Sponsors and contacts

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

Genfleet Therapeutics (Shanghai) Inc.

Lead sponsor

Source ClinicalTrials.gov
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