A Phase 1/2 interventional study of GFH276 in Cancer, PDAC and CRC (Colorectal Cancer), sponsored by Genfleet Therapeutics (Shanghai) Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
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 101st 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 410 of the 602 other live ones, and was the 961st 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 to 75 Years · 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 450 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 study is an investigation to evaluate the safety/tolerability, pharmacokinetics (PK), and efficacy of GFH276 as a single agent in patients with advanced solid tumors harboring RAS mutations.
The primary objectives of the Phase I study are to assess the safety/tolerability, PK, and preliminary efficacy of GFH276 in patients with advanced solid tumors harboring RAS mutations, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of GFH276.
The primary objective of the Phase II study is to evaluate the efficacy of GFH276 in patients with RAS-mutant advanced pancreatic ductal adenocarcinoma (PDAC), advanced non-small cell lung cancer (NSCLC), advanced colorectal cancer (CRC), and other advanced solid tumors.
6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.
This study's planned enrollment of 450 is above the median of 76 across 4,802 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Genfleet Therapeutics (Shanghai) Inc. is the lead sponsor of 18 studies on the registry; 14 are open to participants now.
Compared within Colorectal Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Drug: GFH276
GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Phase Ia:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Time frame: 48 months
Phase Ia:The incidence of DLT events
The incidence of DLT events
Time frame: 21 days
Phase Ib:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Time frame: 48 months
Phase II:Overall response rate (ORR)
Aassessed by investigators according to RECIST 1.1
Time frame: about 48 months
Efficacy endpoints
Duration of response (DoR)
Time frame: about 48 months
Peak Plasma Concentration(Cmax)
Time frame: about 48 months
DCR
he percentage of patients who achieved CR, PR and SD
Time frame: about 48 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Sep 2027, 24 months later.
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 24 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.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GFH276
Genfleet Therapeutics (Shanghai) Inc. →