Pancreatic CancerPhase 1/2NCT07736612
A Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer
A Phase 1/2 study testing HRS-2329 Tablet, Nimotuzumab and HS-20093 in people with Pancreatic Cancer and RAS Mutations or Amplifications, run by Zhejiang University at 1 site in China.
Trial summary
This study aims to evaluate the safety, tolerability, and efficacy of HRS-2329 in combination with other anti-tumor therapies in participants with advanced pancreatic cancer harboring RAS mutations or amplifications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, RAS Mutations or Amplifications
- What is being tested?
- HRS-2329 Tablet, Nimotuzumab and HS-20093
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 30 Dec 2029
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Histopathologically confirmed locally advanced or metastatic pancreatic adenocarcinoma (originating from pancreatic ductal epithelium) that is not amenable to curative therapy.
- RAS mutation or amplification detected in tumor tissue or blood (by RAS testing).
- Prior anti-tumor therapy:
- For cohort HRS-2329-A: at least one line of standard systemic therapy in the advanced setting;
- For cohorts HRS-2329-B and HRS-2329-C: at most one line of standard systemic therapy in the advanced setting.
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- At least one measurable lesion according to RECIST version 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Life expectancy ≥ 3 months.
- Adequate function of vital organs.
- Use of appropriate contraceptive methods during the study period, and so forth.
- Voluntary participation in this study with signed informed consent, good compliance, and willingness to cooperate with follow-up assessments.
Who cannot join
- Prior treatment with drugs similar to the investigational product.
- Known presence of central nervous system (CNS) metastases.
- Acute or chronic pancreatitis requiring clinical intervention.
- Gastrointestinal disorders that may affect drug administration/absorption, including but not limited to dysphagia, malabsorption syndrome, refractory nausea, vomiting, or diarrhea, Crohn's disease, and ulcerative colitis.
- Gastrointestinal obstruction, or signs/symptoms of gastrointestinal obstruction; however, patients who have undergone surgical intervention with complete resolution of the obstruction may be considered for screening.
- Concurrent biliary obstruction with risk of biliary tract infection (patients with treatable biliary obstruction may be enrolled if adequate biliary drainage is achieved and the risk of biliary infection is resolved after treatment).
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- Third-space fluid collections (e.g., massive pleural effusion, ascites) that cannot be stabilised (i.e., no intervention required after drainage removal) within 2 weeks prior to enrolment; patients with only a small amount of fluid detected by imaging and without clinical symptoms may be enrolled.
- Severe infection within 4 weeks prior to enrolment, such as severe pneumonia, bacteraemia, or infectious complications requiring hospitalisation; unexplained fever >38.5°C within 2 weeks prior to enrolment ; signs/symptoms of infection requiring intravenous antibiotic therapy within 2 weeks prior to enrolment.
- Severe cardiovascular or cerebrovascular diseases.
- Known or suspected interstitial lung disease (isolated imaging findings of interstitial changes are not excluded).
- History of definite neurological or psychiatric disorders, including epilepsy and dementia.
- Non-healing wounds (severe, non-healing, or dehiscent), or unhealed fractures.
- Adverse events from prior therapy not recovered to NCI-CTCAE Grade ≤1 at enrolment .
- History of malignancies other than the primary tumour within 5 years prior to enrolment, with the exception of malignancies with low risk of metastasis and death, such as adequately treated carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin.
- Active hepatitis B infection.
- For Cohort C, conditions that are unsuitable for immunotherapy.
- Known allergy to any component of any of the study drugs to be administered.
- Any other condition that, in the investigator's judgement, may affect the study results or result in premature termination of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yiwen Chen, MD. contact
China1 site
the First Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang
About this study
Official title: A Phase Ib/II Study of the Safety, Tolerability, and Efficacy of a Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer
This study aims to evaluate the safety, tolerability, and efficacy of HRS-2329 in combination with other anti-tumor therapies in participants with advanced pancreatic cancer harboring RAS mutations or amplifications.
- Conditions
- Pancreatic Cancer, RAS Mutations or Amplifications
- Being tested
- HRS-2329 Tablet, Nimotuzumab, HS-20093, Adebrelimab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2329 TabletDrug
HRS-2329 is a novel, potent, oral pan-RAS inhibitor. HRS-2329 is given orally (to be swallowed whole, not chewed). It should be taken orally within 30 minutes after breakfast each morning.
NimotuzumabDrug
Nimotuzumab is a marketed drug, a recombinant humanized monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Nimotuzumab is administered at 400 mg by intravenous infusion over at least 60 minutes on Days 1 and 8 of each 3-week cycle.
HS-20093Drug
HS-20093 is a B7-H3 antibody-drug conjugate (ADC).
AdebrelimabDrug
Adebrelimab is a recombinant humanized anti-PD-L1 monoclonal antibody injection. It specifically blocks the binding of PD-1 to PD-L1, thereby terminating the immunosuppressive signals transmitted through PD-1 to T cells. This enables T cells to re-recognize tumor cells and exert cytotoxic effects, ultimately inhibiting tumor growth. Adebrelimab injection is administered at 1200 mg by intravenous infusion on Day 1 of each 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | This arm evaluates HRS-2329 in combination with nimotuzumab in participants with advanced pancreatic cancer harboring RAS mutations or amplifications who have received at least one prior line of therapy. Approximately 6 to 10 participants are planned to be enrolled initially to assess safety and preliminary efficacy, at the prespecified dose of HRS-2329 plus nimotuzumab 400 mg (D1,D8,Q3W). If the safety at this dose level is acceptable, enrollment may be expanded to 15-20 participants. During this period, the Safety Monitoring Committee (SMC) may review the cumulative safety and efficacy data and, after discussion, decide whether to adjust the dose, add other dose groups or dosing frequency arms for further exploration, or discontinue this combination regimen. Receives: Drug: HRS-2329 Tablet; Drug: Nimotuzumab |
| Arm B | Experimental | This arm evaluates HRS-2329 and HS-20093 with or without nimotuzumab in participants with advanced pancreatic cancer harboring RAS mutations or amplifications who are treatment-naïve or have received up to one prior line of standard systemic therapy. Approximately 30 participants are planned to be enrolled. The prespecified doses are HRS-2329 plus HS-20093, with or without nimotuzumab 400 mg on Day 1 and Day 8 of each 3-week cycle. The Safety Monitoring Committee (SMC) may review the cumulative safety and efficacy data and, after discussion, decide whether to adjust the dose, add other dose groups or dosing frequency arms for further exploration, or discontinue this combination regimen. Receives: Drug: HRS-2329 Tablet; Drug: Nimotuzumab; Drug: HS-20093 |
| Arm C | Experimental | Alternative arm: This arm evaluates HRS-2329 and HS-20093 in combination with adebrelimab in participants with advanced pancreatic cancer harboring RAS mutations or amplifications who are treatment-naïve or have received up to one prior line of standard systemic therapy. Approximately 30 participants are planned to be enrolled. The prespecified doses are HRS-2329 plus HS-20093 plus adebrelimab 1200 mg Q3W. The Safety Monitoring Committee (SMC) may review the cumulative safety and efficacy data and, after discussion, decide whether to adjust the dose, add other dose groups or dosing frequency arms for further exploration, or discontinue this combination regimen. Receives: Drug: HRS-2329 Tablet; Drug: HS-20093; Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of patients whose tumor size shrinks as complete response or partial response, as assessed by RECIST1.1.
Measured: From enrollment to upto 2 years
Secondary outcomes (5)
Disease Control Rate (DCR)
defined as the proportion of patients with advanced or metastatic cancer who have achieved a complete response (CR), partial response (PR), or stable disease (SD) as the best overall response, relative to the total number of evaluable patients.
Measured: From enrollment to upto 2 years
Duration of Response
defined as the time from the first documented objective response (Complete Response [CR] or Partial Response [PR]) to the first documented disease progression (per RECIST 1.1 criteria) or death due to any cause, whichever occurs first.
Measured: From enrollment to upto 2 years
Progression-Free Survival
defined as the time from initiation of treatment until the first documented disease progression per RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
Measured: From enrollment to upto 2 years
Overall Survival
defined as the time from initiation of treatment until death from any cause.
Measured: From enrollment to upto 2 years
Adverse event
Safety evaluation was done continuously during treatment by using CTCAE 5.0
Measured: From enrollment to upto 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Dec 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 Zhejiang UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736612
- Sponsor's protocol ID
- CAPT08
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of the Safety, Tolerability, and Efficacy of a Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07736612
- Acronym / sponsor ID
- CAPT08
- Conditions
- Pancreatic Cancer, RAS Mutations or Amplifications
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 30 Jul 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 study aims to evaluate the safety, tolerability, and efficacy of HRS-2329 in combination with other anti-tumor therapies in participants with advanced pancreatic cancer harboring RAS mutations or amplifications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: HRS-2329 Tablet, Drug: NimotuzumabThis arm evaluates HRS-2329 in combination with nimotuzumab in participants with advanced pancreatic cancer harboring RAS mutations or amplifications who have received at least one prior line of therapy. Approximately 6 to 10 participants are planned to be enrolled initially to assess safety and preliminary efficacy, at the prespecified dose of HRS-2329 plus nimotuzumab 400 mg (D1,D8,Q3W). If the safety at this dose level is acceptable, enrollment may be expanded to 15-20 participants. During this period, the Safety Monitoring Committee (SMC) may review the cumulative safety and efficacy data and, after discussion, decide whether to adjust the dose, add other dose groups or dosing frequency arms for further exploration, or discontinue this combination regimen. |
| Arm B | Experimental | Drug: HRS-2329 Tablet, Drug: Nimotuzumab, Drug: HS-20093This arm evaluates HRS-2329 and HS-20093 with or without nimotuzumab in participants with advanced pancreatic cancer harboring RAS mutations or amplifications who are treatment-naïve or have received up to one prior line of standard systemic therapy. Approximately 30 participants are planned to be enrolled. The prespecified doses are HRS-2329 plus HS-20093, with or without nimotuzumab 400 mg on Day 1 and Day 8 of each 3-week cycle. The Safety Monitoring Committee (SMC) may review the cumulative safety and efficacy data and, after discussion, decide whether to adjust the dose, add other dose groups or dosing frequency arms for further exploration, or discontinue this combination regimen. |
| Arm C | Experimental | Drug: HRS-2329 Tablet, Drug: HS-20093, Drug: AdebrelimabAlternative arm: This arm evaluates HRS-2329 and HS-20093 in combination with adebrelimab in participants with advanced pancreatic cancer harboring RAS mutations or amplifications who are treatment-naïve or have received up to one prior line of standard systemic therapy. Approximately 30 participants are planned to be enrolled. The prespecified doses are HRS-2329 plus HS-20093 plus adebrelimab 1200 mg Q3W. The Safety Monitoring Committee (SMC) may review the cumulative safety and efficacy data and, after discussion, decide whether to adjust the dose, add other dose groups or dosing frequency arms for further exploration, or discontinue this combination regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years.
- Histopathologically confirmed locally advanced or metastatic pancreatic adenocarcinoma (originating from pancreatic ductal epithelium) that is not amenable to curative therapy.
- RAS mutation or amplification detected in tumor tissue or blood (by RAS testing).
- Prior anti-tumor therapy:
- At least one measurable lesion according to RECIST version 1.1 criteria.
Key exclusion criteria (18 listed)
- Prior treatment with drugs similar to the investigational product.
- Known presence of central nervous system (CNS) metastases.
- Acute or chronic pancreatitis requiring clinical intervention.
- Gastrointestinal disorders that may affect drug administration/absorption, including but not limited to dysphagia, malabsorption syndrome, refractory nausea, vomiting, or diarrhea, Crohn's disease, and ulcerative colitis.
- Gastrointestinal obstruction, or signs/symptoms of gastrointestinal obstruction; however, patients who have undergone surgical intervention with complete resolution of the obstruction may be considered for screening.
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-2329 TabletHRS-2329 is a novel, potent, oral pan-RAS inhibitor. HRS-2329 is given orally (to be swallowed whole, not chewed). It should be taken orally within 30 minutes after breakfast each morning. | Drug | Arm A, Arm B, Arm C |
| NimotuzumabNimotuzumab is a marketed drug, a recombinant humanized monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Nimotuzumab is administered at 400 mg by intravenous infusion over at least 60 minutes on Days 1 and 8 of each 3-week cycle. | Drug | Arm A, Arm B |
| HS-20093HS-20093 is a B7-H3 antibody-drug conjugate (ADC). | Drug | Arm B, Arm C |
| AdebrelimabAdebrelimab is a recombinant humanized anti-PD-L1 monoclonal antibody injection. It specifically blocks the binding of PD-1 to PD-L1, thereby terminating the immunosuppressive signals transmitted through PD-1 to T cells. This enables T cells to re-recognize tumor cells and exert cytotoxic effects, ultimately inhibiting tumor growth. Adebrelimab injection is administered at 1200 mg by intravenous infusion on Day 1 of each 3-week cycle. | Drug | Arm C |
Primary outcome
Objective Response Rate
Time frame: From enrollment to upto 2 years
The proportion of patients whose tumor size shrinks as complete response or partial response, as assessed by RECIST1.1.
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: From enrollment to upto 2 years
Duration of Response
Time frame: From enrollment to upto 2 years
Progression-Free Survival
Time frame: From enrollment to upto 2 years
Overall Survival
Time frame: From enrollment to upto 2 years
Adverse event
Time frame: From enrollment to upto 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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Yiwen Chen, MD. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRS-2329 Tablet, Nimotuzumab and HS-20093 in people with Pancreatic Cancer and RAS Mutations or Amplifications, run by Zhejiang University 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 12 inclusion and 18 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: opening soon, as of the sponsor's last update on 31 Aug 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Tingbo Liang, MD. (+86 19941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From enrollment to upto 2 years). 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 31 Aug 2026.