A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
NCT06111274 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2024-04-11
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.
Conditions
- Advanced Pancreatic Cancer
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
Abbisko Therapeutics Co, Ltd
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-17
- Primary Completion
- 2025-12-30
- Completion
- 2026-12-29
Countries
- China
Study Locations
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