A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Pimicotinib (ABSK021): The ABSK021 will be taken orally, once daily; The Gemcitabine and nab-Pacilitaxel will be administrated with intravenous infusion on day 1 and 8 of each cycle; The Toripalimab will be administrated with intravenous infusion on day 1 of each cycle.
Study summary
The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab in patients with advanced pancreatic cancer. The main questions it aims to answer are:
* Whether the Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab is safe in patients with advanced pancreatic cancer.
* Whether the Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab is effective in patients with advanced pancreatic cancer.
Participants will be asked to complete the study procedures:
* Receive the administration of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab about 24 weeks in study Part A or Part B.
* Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2.
* Complete the study procedures specified in the protocol, which is guided by researchers.
Eligibility
Primary outcome measure(s)
- Safety Event Occurance — From the day signed informed consent form to day 90 after the end of cycle 8 (each cycle is 21 days)
The Number of Participants With Adverse Event (AE), a Serious Adverse Event (SAE) and Dose Limiting Toxicities (DLT) Event. - Objective Response Rate (ORR) — From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
The Percentage of Participants with confirmed Complete Response and Partial Response, in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | Recruiting |
| West China Hospital of Sichuan University | Chengdu | China | Recruiting |
| Harbin Medical University Cancer Hospital | Ha’erbin | China | Recruiting |
| Shanghai East Hospital Tongji University | Shanghai | China | Recruiting |
| Union Hospital Tongji Medical College Huazhong University of science and technolog | Wuhan | China | Recruiting |
More Abbisko Therapeutics Co, Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06111274 on ClinicalTrials.gov ↗ ← All trials in China