KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line SettingPhase 3NCT07232875
HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer
A Phase 3 study testing HRS-4642 + AG in people with KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting
- What is being tested?
- HRS-4642 + AG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 588 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2025to Apr 2029
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Age 18-75 years old (inclusive) at the time of signing the informed consent form
- Male or female
- ECOG score of 0 or 1
- Expected survival ≥ 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
Who cannot join
- Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study
- Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures
- Known hypersensitivity to any component of HRS-4642; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination
- Received other major surgery other than diagnosis or biopsy within 28 days before the first dose; Minor traumatic surgery (biopsy, laparoscopy, and drainage) within 7 days prior to the first dose; Presence of non-healing wounds (severe, non-healing, or dehiscence), untreated fractures
- Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or who have 5 half-lives of this investigational drug, whichever is shorter
- Use of a live attenuated vaccine within 28 days prior to the first dose of study medication, or anticipated need for a live attenuated vaccine during study treatment
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- Have a history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
- Those who have active pulmonary tuberculosis infection within 1 year before enrollment, or those who have a history of active pulmonary tuberculosis infection more than 1 year ago but have not been formally treated
- Active hepatitis B
- Presence of clinically significant acute or chronic pancreatitis
- Poorly controlled or severe cardiovascular and cerebrovascular diseases, arterior/venous thrombotic events within 6 months prior to study entry
- Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the start of study treatment, but screening can be performed if surgical treatment has been performed and the obstruction has been completely resolved
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
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Liwei Wang
About this study
Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Study of HRS-4642 Combined With Chemotherapy Versus Chemotherapy Alone as First-line Treatment for Advanced or Metastatic Pancreatic Adenocarcinoma Harboring KRAS G12D Mutation
This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.
- Being tested
- HRS-4642 + AG, HRS-4642 placebo + AG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4642 + AGDrug
HRS-4642 + AG
HRS-4642 placebo + AGDrug
HRS-4642 placebo + AG
| Study group | Role | What they receive |
|---|---|---|
| HRS-4642 + AG | Experimental | Not described Receives: Drug: HRS-4642 + AG |
| HRS-4642 placebo + AG | Active comparator | Not described Receives: Drug: HRS-4642 placebo + AG |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS as assessed by BICR per RECIST 1.1
Measured: up to 2 years
OS
Measured: up to 3 years
Secondary outcomes (8)
ORR,as assessed by BICR per RECIST v1.1
Measured: up to 2 years
DCR as assessed by BICR per RECIST v1.1
Measured: up to 2 years
DoR as assessed by BICR per RECIST v1.1
Measured: up to 2 years
PFS as assessed by the investigator per RECIST v1.1.
Measured: up to 2 years
ORRas assessed by the investigator per RECIST v1.1.
Measured: up to 2 years
DCR as assessed by the investigator per RECIST v1.1.
Measured: up to 2 years
DoR as assessed by the investigator per RECIST v1.1.
Measured: up to 2 years
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v5.0.
Measured: Twice a month，up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start21 Nov 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line SettingStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232875
- Sponsor's protocol ID
- HRS-4642-302
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Multicenter Phase III Study of HRS-4642 Combined With Chemotherapy Versus Chemotherapy Alone as First-line Treatment for Advanced or Metastatic Pancreatic Adenocarcinoma Harboring KRAS G12D Mutation
- ClinicalTrials.gov ID
- NCT07232875
- Acronym / sponsor ID
- HRS-4642-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 18 Nov 2025 (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 study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-4642 + AG | Experimental | Drug: HRS-4642 + AG |
| HRS-4642 placebo + AG | Active comparator | Drug: HRS-4642 placebo + AG |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able and willing to provide a written informed consent
- Age 18-75 years old (inclusive) at the time of signing the informed consent form
- Male or female
- ECOG score of 0 or 1
- Expected survival ≥ 12 weeks
Key exclusion criteria (12 listed)
- Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study
- Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures
- Known hypersensitivity to any component of HRS-4642; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination
- Received other major surgery other than diagnosis or biopsy within 28 days before the first dose; Minor traumatic surgery (biopsy, laparoscopy, and drainage) within 7 days prior to the first dose; Presence of non-healing wounds (severe, non-healing, or dehiscence), untreated fractures
- Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or who have 5 half-lives of this investigational drug, whichever is shorter
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 |
|---|---|---|
| HRS-4642 + AGHRS-4642 + AG | Drug | HRS-4642 + AG |
| HRS-4642 placebo + AGHRS-4642 placebo + AG | Drug | HRS-4642 placebo + AG |
Primary outcome
PFS as assessed by BICR per RECIST 1.1
Time frame: up to 2 years
OS
Time frame: up to 3 years
8 secondary outcomes
ORR,as assessed by BICR per RECIST v1.1
Time frame: up to 2 years
DCR as assessed by BICR per RECIST v1.1
Time frame: up to 2 years
DoR as assessed by BICR per RECIST v1.1
Time frame: up to 2 years
PFS as assessed by the investigator per RECIST v1.1.
Time frame: up to 2 years
ORRas assessed by the investigator per RECIST v1.1.
Time frame: up to 2 years
DCR as assessed by the investigator per RECIST v1.1.
Time frame: up to 2 years
DoR as assessed by the investigator per RECIST v1.1.
Time frame: up to 2 years
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v5.0.
Time frame: Twice a month，up to 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 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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 3 study testing HRS-4642 + AG in people with KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting, run by Jiangsu HengRui Medicine Co., Ltd. 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 6 inclusion and 12 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 26 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hongxia Han (+0518-81220121, hongxia.han@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS as assessed by BICR per RECIST 1.1 (time frame: up to 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 26 Oct 2026.