Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer

NCT06547736 | Recruiting Phase 2

• 1 other identifier: PANC-IIT-PLATFORM
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Recommended phase II dose (RP2D)

  RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.

  Approximately 12 months

• Objective Response Rate (ORR)

  Evaluated by RECIST v1.1.

  Up to approximately 12 months]

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  Up to approximately 12 months

• Duration of Response (DOR)

  Up to approximately 12 months

• Progression Free Survival (PFS)

  Up to approximately 12 months

• Overall survival (OS)

  Up to approximately 12 months

• Adverse events (AEs)

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

Study Arms (4)

Arm A

EXPERIMENTAL

SHR-A2102 monotherapy or combination therapy with HRS-4642 for treatment of advanced or metastatic PDAC.

Drug: SHR-A2102 or/and HRS-4642

Arm B

EXPERIMENTAL

SHR-A1904 monotherapy or combination therapy with HRS-4642 for treatment of advanced or metastatic PDAC.

Drug: SHR-A1904 or/and HRS-4642

Arm C

EXPERIMENTAL

SHR-A1811 monotherapy or combination therapy with HRS-4642 for treatment of advanced or metastatic PDAC.

Drug: SHR-A1811 or/and HRS-4642

Arm D

EXPERIMENTAL

SHR-A2102 combination with HRS-4642 and immunotherapy for treatment of advanced or metastatic PDAC.

Drug: SHR-A2102, HRS4642 and Adebrelimab

Interventions

SHR-A2102 or/and HRS-4642 DRUG

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.

Arm A

SHR-A1904 or/and HRS-4642 DRUG

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.

Arm B

SHR-A1811 or/and HRS-4642 DRUG

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.

Arm C

SHR-A2102, HRS4642 and Adebrelimab DRUG

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.

Arm D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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);
• 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.

Sponsors & Collaborators

• Fudan University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Si Shi, PHD

CONTACT

+86-021-64179375; shisi@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-10

Locations

CN (1)