Advanced Solid Tumors CancerPhase 1/2NCT07678593
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
A Phase 1/2 study testing GFH276, Cetuximab and Nab paclitaxel in people with Advanced Solid Tumors Cancer and Pancreatic Ductal Adenocarcinoma, run by Genfleet Therapeutics (Shanghai) Inc. at 17 sites in 2 countries.
Trial summary
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors Cancer, Pancreatic Ductal Adenocarcinoma, RAS Mutation
- What is being tested?
- GFH276, Cetuximab and Nab paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Sep 2026to Sep 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Life expectancy > 3 months
- Adequate organ function
- Willing to provide written informed consent
- Fertile participants must use effective contraception
Who cannot join
- 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.
- With active infection (HIV, HBV, HCV, syphilis)
- The presence of clinical or radiological evidence of intestinal obstruction.
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- Prior anticancer therapy within 28 days or 5 half-lives
- Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months
- Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.
- History of central nervous system (CNS)disease
- Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.
- With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
China11 sites, 11 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Chunmei Bai, MD
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Xuelei Ma, MD
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Zhihua Li, MD
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Da Li, MD
- Not yet recruiting
The Third Affiliated Hospital (Cancer Hospital) of Harbin Medical University
Harbin, Heilongjiang, 150081
Guangyu Wang, MD
- Recruiting
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, 250117
Shuqin Ni, MD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, MD, 13801669875, yuxianjun@fudanpci.org
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Xiujuan Qu, MD
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Heshui Wu, MD
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yinying Wu, MD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Hong Zong, MD
Australia6 sites, 6 recruiting
- Recruiting
Monash Health (Monash Medical Centre)
Clayton, Victoria, 3168
David Lau, PhD, 0385722392, David.Lau@monashhealth.org
- Not yet recruiting
Concord Cancer Centre, Concord Repatriation General Hospital, Sydney Local Health District
Concord, New South Wales, 2139
Kim Tam B Bui, MBBS, 0297674425, Tam.Bui@health.nsw.gov.au
- Not yet recruiting
Northern Health
Epping, Victoria, 3076
Belinda Lee, MBBS, 0384058000, Belinda.Lee@nh.org.au
- Recruiting
PASO Medical
Frankston, Victoria, 3199
Vinod Ganju, MBBS, 0397815244, vg@paso.com.au
- Recruiting
Macquarie University / Clinical Trials Unit
North Ryde, New South Wales, 2109
Andrew Parsonson, PhD, 0298122956, andrew.parsonson@mqhealth.org.au
PhD
- Not yet recruiting
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Timothy Price, MBBS, 0882227096, timothy.price@sa.gov.au
About this study
Official title: 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
Read the detailed description
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.
- Being tested
- GFH276, Cetuximab, Nab paclitaxel, Gemcitabine, Fluorouracil
- Keywords
- GFH276, PDAC, RAS Mutation, solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH276Drug
Oral GFH276 administered once daily in combination with other study drugs.
CetuximabDrug
Intravenous cetuximab at a dose of 500 mg/m²
Nab paclitaxelDrug
Intravenous nab-paclitaxel at a dose of 125 mg/m².
GemcitabineDrug
Intravenous Gemcitabine at a dose of 1000 mg/m².
FluorouracilDrug
Intravenous Fluorouracil at a dose of 2400 mg/m² via 46-hour infusion.Dosing may follow the above regimen or local institutional standards.
LeucovorinDrug
Intravenous leucovorin at a dose of 400 mg/m².Dosing may follow the above regimen or local institutional standards.
IrinotecanDrug
Intravenous irinotecan at a dose of 150 mg/m².Dosing may follow the above regimen or local institutional standards.
OxaliplatinDrug
Intravenous oxaliplatin at a dose of 85 mg/m².Dosing may follow the above regimen or local institutional standards.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: GFH276 + Cetuximab | Experimental | GFH276 once daily; cetuximab 500 mg/m² intravenous infusion every 2 weeks. Receives: Drug: GFH276; Drug: Cetuximab |
| Arm B: GFH276 + AG | Experimental | 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 Receives: Drug: GFH276; Drug: Nab paclitaxel; Drug: Gemcitabine |
| Arm C: GFH276 + mFOLFIRINOX | Experimental | 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. Receives: Drug: GFH276; Drug: Fluorouracil; Drug: Leucovorin; Drug: Irinotecan; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events
The incidence of DLT events
Measured: First 28 days (21 days for AG （3-week cycle）)
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
Measured: From the first dose until 30 days after the last dose, assessed up to 24 months
Phase II:Objective Response Rate (ORR)
Assessed by investigators according to RECIST 1.1
Measured: 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
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
Measured: up to 24 months
Phase Ib: Number of participants with abnormality in clinical chemistry laboratory assessments
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.
Measured: up to 24 months
Phase Ib: Number of participants with abnormality in body temperature
Number of participants with abnormality in body temperature(°C), throughout the study.
Measured: up to 24 months
Phase Ib: Number of participants with abnormality in blood pressure
Number of participants with abnormality in blood pressure, including systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Measured: up to 24 months
Phase Ib: Number of participants with abnormality in Physical Examination Findings
Number of participants with abnormality in Physical Examination Findings
Measured: up to 24 months
Phase Ib: Number of participants with abnormality in PR interval
Number of participants with abnormality in electrocardiogram (ECG) parameters, including PR interval
Measured: up to 24 months
Phase Ib: Number of participants with abnormality in corrected QT interval using Frederica's formula (QTcF)
Number of participants with abnormality incorrected QT interval using Frederica's formula (QTcF)
Measured: up to 24 months
Secondary outcomes (9)
Phase II: Incidence and Severity of AE and SAE
Incidence and Severity of AE and SAE，Assessed according to CTCAE 6.0
Measured: From the first dose until 30 days after the last dose, assessed up to 24 months
DCR
Disease Control Rate (DCR)
Measured: 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
Duration of Response assessed by investigators
Measured: 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
Time To Response assessed by investigators
Measured: 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
Progression-Free Survival (PFS) per Response Evaluation Criteria according to RECIST 1.1, as Determined by investigators
Measured: 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
OS
Overall Survival
Measured: From the first dose until date of death from any cause, assessed up to 24 months
Time to peak plasma concentration（Tmax） of GFH276
Plasma concentrations of GFH276 and relevant pharmacokinetic parameters including Tmax were evaluated.
Measured: up to 6 months
Maximum plasma concentration of GFH276
Plasma concentrations of GFH276 and relevant pharmacokinetic parameters including Cmax were evaluated.
Measured: up to 6 months
Area Under the Curve from time zero to 24 hours of GFH276
Plasma concentrations of GFH276 and relevant pharmacokinetic parameters including AUC0-24 were evaluated.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678593
- Sponsor's protocol ID
- GFH276X0201
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No