Pancreatic Ductal Adenocarcinoma Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).

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 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;

• 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;

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
Shisi@fudanpci.org
+86-021-64179375
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2028-03
Participants
Target number of participants: 130
Treatments
Experimental: dose escalation
HRS-4642+Adebrelimab
Experimental: efficacy exploration-Arm1
HRS-4642+Adebrelimab
Experimental: efficacy exploration-Arm2
HRS-4642
Experimental: efficacy exploration-Arm3
HRS-4642 + Adebrelimab + SHR-8068
Experimental: efficacy exploration-Arm4
HRS-4642+Adebrelimab+Faminitib/Bevacizumab
Sponsors
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Leads: Fudan University

This content was sourced from clinicaltrials.gov