A Phase 1/2 interventional study of GFH375 and GFH375 in Advanced Solid Tumors Cancer, PDAC and CRC (Colorectal Cancer), sponsored by Genfleet Therapeutics (Shanghai) Inc.. Recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Genfleet Therapeutics (Shanghai) Inc. · Phase 1/2, Interventional, and Treatment
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Among 1,134 studies in Colorectal Neoplasms with a site in China — 526 open to participants now, 603 under way, 67 of them phase 3. Colorectal Neoplasms · China.
Among the 1,134 studies in Colorectal Neoplasms with a site in China, this one is the 320th largest by planned enrollment of the 889 interventional ones that give a count, is one of 125 that started in 2025, is one of 94 in phase 1/2, reaches primary completion later than 399 of the 602 other live ones, and was the 974th registered.
6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.
Browse Colorectal Neoplasms studies →526 of the 1,134 studies in Colorectal Neoplasms with a site in China are open now. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18–75
Fudan University · Sites in China
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
Shanghai EpimAb Biotherapeutics Co., Ltd. · Sites in China
Ages 18–74
Nanjing Leads Biolabs Co.,Ltd · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,134 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 224 · Phase 2 465 · Phase 3 147 · Phase 4 21
First in 1993; this study’s year is marked. 125 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 126 is above the median of 76 across 4,802 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 80 across the 889 interventional studies, 400 across the 243 observational. Of the 213 that completed or were terminated, 27 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
247 of 1,134 have an industry lead sponsor. The 10 most frequent:
Genfleet Therapeutics (Shanghai) Inc. is the lead sponsor of 18 studies on the registry; 14 are open to participants now.
Genfleet Therapeutics (Shanghai) Inc. has 3 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
142 of the studies in Colorectal Neoplasms with a site in China that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06008119Phase 3Shanghai Kechow Pharma, Inc.Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer | 2026-12-24 |
| NCT05171660Phase 3Second Affiliated Hospital, School of Medicine, Zhejiang UniversityCombination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer | 2026-12-30 |
| NCT03303495Phase 3Sun Yat-sen UniversityA Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC | 2026-12-31 |
| NCT06280495Phase 3Sun Yat-sen UniversityNeoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients | 2026-12-31 |
| NCT05086614Phase 3Fudan UniversityThymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer | 2027-03-31 |
Add all 142 to your calendar (.ics) → With an account.
Among the 1,134 studies in Colorectal Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety/tolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm A will enroll participants with locally advanced or metastatic solid tumors with KRAS G12D mutation.
Combination Product: GFH375
Arm B will enroll participants with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutation.
Combination Product: GFH375
GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.
Also known as: Cetuximab
GFH375 once daily (QD). Paclitaxel (albumin-bound) at 125 mg/m² and gemcitabine at 1000 mg/m² will be administered via intravenous infusion on Days 1, 8, and 15 of each 4-week cycle.
Also known as: Paclitaxel (albumin-bound), gemcitabine
Phase Ib: Incidence of Dose-Limiting Toxicity (DLT) Events
Time frame: up to 28 days
Phase Ib: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: From the first dose until 30 days after the last dose, assessed up to 24 months
Phase II: Objective Response Rate (ORR) Evaluated by 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
Plasma concentrations of GFH375
Plasma concentrations of GFH375
Time frame: up to 6 months
Phase II: Incidence and Severity of AE and SAE
Time frame: From the first dose until 30 days after the last dose, assessed up to 24 months
DCR
DCR 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
TTR
TTR 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
DOR
DoR 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
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors
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
OS
Overall Survival
Time frame: From the first dose until date of death from any cause, assessed up to 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jul 2027, 21 months after the start.
Of 158 industry-sponsored phase 1/2 interventional studies under Colorectal Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's planned 21 months is below that.
Counting every sponsor, half of 260 studies reached it within 59 months; a quarter within 36 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: KRAS G12D Inhibitor VS-7375
Genfleet Therapeutics (Shanghai) Inc. →