Pancreatic CancerPhase 2NCT07784374
A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
A Phase 2 study testing GFH375, GFH276 and GFS202A in people with Pancreatic Cancer, run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.
Trial summary
This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- GFH375, GFH276 and GFS202A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 31 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent prior to any study-related procedures.
- Male or female subjects aged between 18 and 80 years (inclusive) at the time of informed consent.
- Histologically or cytologically confirmed pancreatic adenocarcinoma.
- Estimated life expectancy ≥ 3 months as judged by the investigator.
- Has received at least 1 prior line of systemic anti-tumor therapy.
- Has at least one measurable lesion per RECIST version 1.1.
- Adequate organ function.
Who cannot join
- Other malignancy that has progressed or required treatment within 3 years prior to study entry.
- Active central nervous system (CNS) metastases.
- Prior treatment with KRAS G12D-specific or pan-RAS/KRAS targeted agents.
- Clinically significant severe cardiovascular disease.
- Stroke or other severe cerebrovascular events within 6 months prior to randomization.
- Significant acute or chronic infectious disease.
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- Severe psychiatric disorder, history of drug abuse, or significant alcohol abuse.
- Pregnant or lactating female subjects.
- Other conditions that, in the investigator's opinion, make the subject unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Baiyong Shen, Ph D, +86-021-64370045, shenby@shsum.edu.cn
About this study
Official title: A Phase II, Multicenter, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of GFH375 in Combination With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy. The purpose of this study is to evaluate the anti-tumor efficacy of GFH375 plus GFH276 versus GFH375 monotherapy, and to assess the impact of GFH375 plus GFS202A versus GFH375 monotherapy on patient body weight.
- Conditions
- Pancreatic Cancer
- Being tested
- GFH375, GFH276, GFS202A
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH375Drug
administered per protocol-specified schedule
GFH276Drug
administered per protocol-specified schedule
GFS202ADrug
administered per protocol-specified schedule
| Study group | Role | What they receive |
|---|---|---|
| GFH375+GFH276 | Experimental | Not described Receives: Drug: GFH375; Drug: GFH276 |
| GFH375+GFS202A | Experimental | Not described Receives: Drug: GFH375; Drug: GFS202A |
| GFH375 | Experimental | Not described Receives: Drug: GFH375 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1
Measured: Up to approximately 2 years
Weight
Percentage Change in Body Weight From Baseline at Week 12
Measured: Baseline, From first study treatment to Week 12
Secondary outcomes (10)
OS
Overall Survival (OS)
Measured: Up to approximately 3 years
PFS
Progression-Free Survival (PFS) Assessed by Investigator per RECIST Version 1.1
Measured: Up to approximately 2 years
ORR
Objective Response Rate (ORR), Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1
Measured: Up to approximately 2 years
DCR
Disease Control Rate (DCR)Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1
Measured: Up to approximately 2 years
DoR
Duration of Response (DoR)Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1
Measured: Up to approximately 2 years
TTR
Time-to-Response (TTR) Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1
Measured: Up to approximately 2 years
The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Measured: Up to approximately 2 years
Plasma concentration of GFH375
Trough concentration of GFH375
Measured: Up to approximately 2 years
Plasma concentration of GFH276
Trough concentration of GFH276
Measured: Up to approximately 2 years
Plasma concentration of GFS202A
Trough concentration of GFS202A
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Aug 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Genfleet Therapeutics (Shanghai) Inc.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT07784374
- Sponsor's protocol ID
- GFH375X1203
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of GFH375 in Combination With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
- ClinicalTrials.gov ID
- NCT07784374
- Acronym / sponsor ID
- GFH375X1203
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy. The purpose of this study is to evaluate the anti-tumor efficacy of GFH375 plus GFH276 versus GFH375 monotherapy, and to assess the impact of GFH375 plus GFS202A versus GFH375 monotherapy on patient body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GFH375+GFH276 | Experimental | Drug: GFH375, Drug: GFH276 |
| GFH375+GFS202A | Experimental | Drug: GFH375, Drug: GFS202A |
| GFH375 | Experimental | Drug: GFH375 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide written informed consent prior to any study-related procedures.
- Male or female subjects aged between 18 and 80 years (inclusive) at the time of informed consent.
- Histologically or cytologically confirmed pancreatic adenocarcinoma.
- Estimated life expectancy ≥ 3 months as judged by the investigator.
- Has received at least 1 prior line of systemic anti-tumor therapy.
Key exclusion criteria (9 listed)
- Other malignancy that has progressed or required treatment within 3 years prior to study entry.
- Active central nervous system (CNS) metastases.
- Prior treatment with KRAS G12D-specific or pan-RAS/KRAS targeted agents.
- Clinically significant severe cardiovascular disease.
- Stroke or other severe cerebrovascular events within 6 months prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFH375administered per protocol-specified schedule | Drug | GFH375, GFH375+GFH276, GFH375+GFS202A |
| GFH276administered per protocol-specified schedule | Drug | GFH375+GFH276 |
| GFS202Aadministered per protocol-specified schedule | Drug | GFH375+GFS202A |
Primary outcome
PFS
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1
Weight
Time frame: Baseline, From first study treatment to Week 12
Percentage Change in Body Weight From Baseline at Week 12
10 secondary outcomes
OS
Time frame: Up to approximately 3 years
PFS
Time frame: Up to approximately 2 years
ORR
Time frame: Up to approximately 2 years
DCR
Time frame: Up to approximately 2 years
DoR
Time frame: Up to approximately 2 years
TTR
Time frame: Up to approximately 2 years
The incidence and severity of AEs and SAEs
Time frame: Up to approximately 2 years
Plasma concentration of GFH375
Time frame: Up to approximately 2 years
Plasma concentration of GFH276
Time frame: Up to approximately 2 years
Plasma concentration of GFS202A
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GFH375, GFH276 and GFS202A in people with Pancreatic Cancer, run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lizhi Yi +86 21 6882 1388 (+86 21 6882 1388, lzyi@genfleet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.