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Pancreatic CancerPhase 2NCT06547736

Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer

A Phase 2 study testing SHR-A2102 or/and HRS-4642, SHR-A1904 or/and HRS-4642 and SHR-A1811 or/and HRS-4642 in people with Pancreatic Cancer, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study is being conducted to evaluate the safety, tolerability and efficacy of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy in subjects with locally advanced or metastatic pancreatic cancer. 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?
SHR-A2102 or/and HRS-4642, SHR-A1904 or/and HRS-4642 and SHR-A1811 or/and HRS-4642
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
14 Oct 2024to Jun 2027
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 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 cancer; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  • Life expectancy ≥ 12 weeks;
  • Adequate marrow and organ function;
  • 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 6 months after the last study administration;

Who cannot join

  • Known to be allergic to the investigational drug or any of its components;
  • 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;
  • Have other active malignancies within 5 years;
  • Accompanied by untreated or active central nervous system (CNS) metastases;
  • Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria;
  • 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);
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  • With gastrointestinal obstruction or symptoms and signs of gastrointestinal obstruction within 6 months before the start of treatment, but if surgical treatment has been performed and the obstruction is completely relieved, screening can be conducted;
  • Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism;
  • With congenital or acquired immune deficiency, such as people infected with HIV, active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] in screening period is positive and HBV-DNA detection value ≥ 10000 copies/ml [2000 IU/ml] or active hepatitis C (defined as hepatitis C virus antibody [HCV Ab] in screening period is positive and HCV RNA is positive);
  • With active pulmonary tuberculosis infection within one year prior to enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;
  • Participated in other clinical studies or whose first medication is less than 4 weeks after the end of the previous clinical study (last medication), or whose study drug has a half-life of 5, whichever is shorter;
  • High risk of pancreatitis, serum amylase and/or lipase concentrations ≥ 3 times ULN, will be evaluated by the researchers;
  • Uncontrollable mental illnesses and other known factors that affect the completion of research procedures, such as alcohol, drug or substance abuse, criminal detention, etc;
  • Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration; Experiencing traumatic minor surgery (biopsy, endoscopic examination, and drainage surgery) within 7 days prior to the first administration;
  • 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.

Si Shi, PHD contact

+86-021-64179375

shisi@fudanpci.org

China1 site, 1 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.

    Recruiting

Other trials in China

About this study

Official title: A Single-center, Open-label, Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer

The study is being conducted to evaluate the safety, tolerability and efficacy of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy in subjects with locally advanced or metastatic pancreatic cancer.

Read the detailed description

This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy in the treatment of patients with unresectable locally advanced or metastatic pancreatic cancer.

This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. During the dose exploration phase, RP2D was determined based on the safety, tolerability, and preliminary efficacy data of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy, and then entered the efficacy exploration phase.

Being tested
SHR-A2102 or/and HRS-4642, SHR-A1904 or/and HRS-4642, SHR-A1811 or/and HRS-4642, SHR-A2102, HRS4642 and 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.

  • SHR-A2102 or/and HRS-4642Drug

    Drug: SHR-A2102 SHR-A2102 will be administrated per dose level in which the patients are assigned.

    Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.

  • SHR-A1904 or/and HRS-4642Drug

    Drug: SHR-A1904 SHR-A1904 will be administrated per dose level in which the patients are assigned.

    Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.

  • SHR-A1811 or/and HRS-4642Drug

    Drug: SHR-A1811 SHR-A1811 will be administrated per dose level in which the patients are assigned.

    Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.

  • SHR-A2102, HRS4642 and AdebrelimabDrug

    Drug: SHR-A2102 SHR-A2102 will be administrated per dose level in which the patients are assigned.

    Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.

    Drug: Adebrelimab Adebrelimab will be administrated per dose level in which the patients are assigned.

Study groups in NCT06547736
Study groupRoleWhat they receive
Arm AExperimentalSHR-A2102 monotherapy or combination therapy with HRS-4642 for treatment of advanced or metastatic PDAC.
Receives: Drug: SHR-A2102 or/and HRS-4642
Arm BExperimentalSHR-A1904 monotherapy or combination therapy with HRS-4642 for treatment of advanced or metastatic PDAC.
Receives: Drug: SHR-A1904 or/and HRS-4642
Arm CExperimentalSHR-A1811 monotherapy or combination therapy with HRS-4642 for treatment of advanced or metastatic PDAC.
Receives: Drug: SHR-A1811 or/and HRS-4642
Arm DExperimentalSHR-A2102 combination with HRS-4642 and immunotherapy for treatment of advanced or metastatic PDAC.
Receives: Drug: SHR-A2102, HRS4642 and Adebrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Objective Response Rate (ORR)

    Evaluated by RECIST v1.1.

    Measured: Up to approximately 12 months]

Secondary outcomes (5)

  1. Disease Control Rate (DCR)

    Evaluated by RECIST v1.1.

    Measured: Up to approximately 12 months

  2. Duration of Response (DOR)

    Evaluated by RECIST v1.1.

    Measured: Up to approximately 12 months

  3. 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

  4. 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

  5. Adverse events (AEs)

    AEs are assessed by NCI-CTCAE v5.0

    Measured: From the first drug administration to within 90 days for the last ADC durgs dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start14 Oct 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06547736
Sponsor's protocol ID
PANC-IIT-PLATFORM
Status last verified
Oct 2025
First submitted
7 Aug 2024
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-A2102 or/and HRS-4642, SHR-A1904 or/and HRS-4642 and SHR-A1811 or/and HRS-4642 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 7 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 5 Jan 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 Si Shi, PHD (+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?

Recommended phase II dose (RP2D) (time frame: Approximately 12 months). 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?

On the ClinicalTrials.gov record for NCT06547736.

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 5 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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