Pancreatic CancerPhase 1/2NCT06427239
Exploratory Clinical Study of HRS-4642 Combined With Adebrelimab in the Treatment of Advanced Pancreatic Ductal Adenocarcinoma
A Phase 1/2 study testing HRS-4642, Adebrelimab and SHR-8068 in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebrelimab, or with adebrelimab and other antitumor agents in patients with advanced pancreatic ductal adenocarcinoma (PDAC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- HRS-4642, Adebrelimab and SHR-8068
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2024to Mar 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients volunteered to participate in this study and signed informed consent;
- Age: ≥18 and ≤75 years old, male or female;
- Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
- With failure or absence of standard treatment, and progress within 6 months of adjuvant therapy can also be included in the study;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 12 weeks;
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- Adequate marrow and organ function;
- AE caused by previous anti-tumor therapy must be restored to ≤ level 1 (CTCAE v5.0) or a stable state evaluated by the researcher, except for hair loss (any level) and peripheral neuropathy of level 2;
- Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 3 months after the last study administration;
Who cannot join
- Known to be allergic to the investigational drug or any of its components;
- Have other active malignancies within 5 years;
- Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the first dose;
- Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation;
- Accompanied by untreated or active central nervous system (CNS) metastases;
- Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism;
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- Hypertension with poor drug control (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg);
- Late stage patients with symptoms that have spread to the internal organs and are at risk of life-threatening complications in the short term;
- With interstitial lung disease, non-infectious pneumonia, severe and uncontrolled internal medicine diseases, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
- Participated in clinical trials of any drug or medical device within 4 weeks prior to the first administration;
- With congenital or acquired immune deficiency, such as people infected with HIV, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection;
- With any active autoimmune diseases or a history of autoimmune diseases;
- Received systemic treatment with corticosteroids or other immunosuppressants within 2 weeks prior to the first medication;
- High risk of pancreatitis, serum amylase and/or lipase concentrations ≥ 3 times ULN; who have a simple increase in lipase, will be considered for inclusion by the researchers;
- Other situations that researchers believe should not be included.
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
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
XianJun Yu, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org
Xianjun Yu, M.D., Ph.D.
About this study
Official title: A Single-center, Open-label, Exploratory Study of HRS-4642 Combined With Adebrelimab, or With Adebrelimab and Other Antitumor Agents in the Treatment of Advanced Pancreatic Ductal Adenocarcinoma
The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebrelimab, or with adebrelimab and other antitumor agents in patients with advanced pancreatic ductal adenocarcinoma (PDAC).
Read the detailed description
This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of HRS-4642 combined with adebrelimab, or with adebrelimab and other antitumor agents in the treatment of patients with advanced PDAC.
This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. Additional arms may be added based on emerging data.
- Conditions
- Pancreatic Cancer
- Being tested
- HRS-4642, Adebrelimab, SHR-8068, Faminitib or bevacizumab
- 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-4642Drug
Specified dose on specified days
AdebrelimabDrug
Specified dose on specified days
SHR-8068Drug
Specified dose on specified days
Faminitib or bevacizumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| dose escalation | Experimental | HRS-4642+Adebrelimab Receives: Drug: HRS-4642; Drug: Adebrelimab |
| efficacy exploration-Arm1 | Experimental | HRS-4642+Adebrelimab Receives: Drug: HRS-4642; Drug: Adebrelimab |
| efficacy exploration-Arm2 | Experimental | HRS-4642 Receives: Drug: HRS-4642 |
| efficacy exploration-Arm3 | Experimental | HRS-4642 + Adebrelimab + SHR-8068 Receives: Drug: HRS-4642; Drug: Adebrelimab; Drug: SHR-8068 |
| efficacy exploration-Arm4 | Experimental | HRS-4642+Adebrelimab+Faminitib/Bevacizumab Receives: Drug: HRS-4642; Drug: Adebrelimab; Drug: Faminitib or bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity (DLT)
A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness
Measured: Day 1 to Day 21 after the first combination therapy was administrated
Recommended phase II dose (RP2D)
RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.
Measured: Approximately 12 months
Objective Response Rate (ORR)
Evaluated by RECIST v1.1.
Measured: Up to approximately 12 months
Secondary outcomes (5)
Disease Control Rate (DCR)
Evaluated by RECIST v1.1.
Measured: Up to approximately 12 months
Duration of Response (DOR)
Evaluated by RECIST v1.1.
Measured: Up to approximately 12 months
Progression Free Survival (PFS)
Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Measured: Up to approximately 12 months
Overall survival (OS)
Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Measured: Up to approximately 12 months
Adverse events (AEs)
AEs are assessed by NCI-CTCAE v5.0
Measured: From the first drug administration to within 90 days for the last adebrelimab dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start17 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionMar 2028 (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 Fudan 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427239
- Sponsor's protocol ID
- PANC-2nd-IIT-HRS4642-SHR1316
- Status last verified
- May 2026
- First submitted
- 19 May 2024
- Last updated
- 26 May 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Exploratory Study of HRS-4642 Combined With Adebrelimab, or With Adebrelimab and Other Antitumor Agents in the Treatment of Advanced Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06427239
- Acronym / sponsor ID
- PANC-2nd-IIT-HRS4642-SHR1316
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 May 2024 (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.
The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebrelimab, or with adebrelimab and other antitumor agents in patients with advanced pancreatic ductal adenocarcinoma (PDAC).
Detailed description
This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of HRS-4642 combined with adebrelimab, or with adebrelimab and other antitumor agents in the treatment of patients with advanced PDAC.
This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. Additional arms may be added based on emerging data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dose escalation | Experimental | Drug: HRS-4642, Drug: AdebrelimabHRS-4642+Adebrelimab |
| efficacy exploration-Arm1 | Experimental | Drug: HRS-4642, Drug: AdebrelimabHRS-4642+Adebrelimab |
| efficacy exploration-Arm2 | Experimental | Drug: HRS-4642HRS-4642 |
| efficacy exploration-Arm3 | Experimental | Drug: HRS-4642, Drug: Adebrelimab, Drug: SHR-8068HRS-4642 + Adebrelimab + SHR-8068 |
| efficacy exploration-Arm4 | Experimental | Drug: HRS-4642, Drug: Adebrelimab, Drug: Faminitib or bevacizumabHRS-4642+Adebrelimab+Faminitib/Bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients volunteered to participate in this study and signed informed consent;
- Age: ≥18 and ≤75 years old, male or female;
- Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
- With failure or absence of standard treatment, and progress within 6 months of adjuvant therapy can also be included in the study;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Key exclusion criteria (15 listed)
- Known to be allergic to the investigational drug or any of its components;
- Have other active malignancies within 5 years;
- Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the first dose;
- Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation;
- Accompanied by untreated or active central nervous system (CNS) metastases;
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-4642Specified dose on specified days | Drug | dose escalation, efficacy exploration-Arm1, efficacy exploration-Arm2, efficacy exploration-Arm3, efficacy exploration-Arm4 |
| AdebrelimabSpecified dose on specified days | Drug | dose escalation, efficacy exploration-Arm1, efficacy exploration-Arm3, efficacy exploration-Arm4 |
| SHR-8068Specified dose on specified days | Drug | efficacy exploration-Arm3 |
| Faminitib or bevacizumabSpecified dose on specified days | Drug | efficacy exploration-Arm4 |
Primary outcome
Dose Limited Toxicity (DLT)
Time frame: Day 1 to Day 21 after the first combination therapy was administrated
A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness
Recommended phase II dose (RP2D)
Time frame: Approximately 12 months
RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.
Objective Response Rate (ORR)
Time frame: Up to approximately 12 months
Evaluated by RECIST v1.1.
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to approximately 12 months
Duration of Response (DOR)
Time frame: Up to approximately 12 months
Progression Free Survival (PFS)
Time frame: Up to approximately 12 months
Overall survival (OS)
Time frame: Up to approximately 12 months
Adverse events (AEs)
Time frame: From the first drug administration to within 90 days for the last adebrelimab dose
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 May 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 1/2 study testing HRS-4642, Adebrelimab and SHR-8068 in people with Pancreatic Cancer, run by Fudan 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 9 inclusion and 15 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 May 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 Si Shi (+86-021-64179375, Shisi@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicity (DLT) (time frame: Day 1 to Day 21 after the first combination therapy was administrated). The study lists 3 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 May 2026.