Trials / Recruiting
RecruitingNCT06111274
A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
A Multicenter, Open-Label Phase II Study To Evaluate The Efficacy And Safety Of ABSK021 In Combination With Chemotherapy With Or Without Toripalimab In Patients With Advanced Pancreatic Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- Sponsor
- Abbisko Therapeutics Co, Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a phase II, open-label study to evaluate safety, tolerability, pharmacokinetics (PK), and clinical benefit of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab in patients with advanced pancreatic cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-10-17
- Primary completion
- 2025-12-30
- Completion
- 2026-12-29
- First posted
- 2023-11-01
- Last updated
- 2024-04-11
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06111274. Inclusion in this directory is not an endorsement.