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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Si Shi, PHD
shisi@fudanpci.org
+86-021-64179375
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2027-06
Participants
Target number of participants: 160
Treatments
Experimental: Arm A
SHR-A2102 monotherapy or combination therapy with HRS-4642 for treatment of advanced or metastatic PDAC.
Experimental: Arm B
SHR-A1904 monotherapy or combination therapy with HRS-4642 for treatment of advanced or metastatic PDAC.
Experimental: Arm C
SHR-A1811 monotherapy or combination therapy with HRS-4642 for treatment of advanced or metastatic PDAC.
Experimental: Arm D
SHR-A2102 combination with HRS-4642 and immunotherapy for treatment of advanced or metastatic PDAC.
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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