Evaluating Pimicotinib with Chemotherapy for 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
This study is testing if a new drug called Pimicotinib, used with chemotherapy, can help people with advanced pancreatic cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Abbisko Therapeutics Co, Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, Toripalimab, Pimicotinib |
| Locations | 5 sites (Shanghai, Shanghai Municipality and 4 other locations) |
| Trial ID | NCT06111274 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of Pimicotinib (ABSK021) in combination with chemotherapy, with or without Toripalimab, in patients suffering from advanced pancreatic cancer. Participants will receive treatment over a period of approximately 24 weeks and will undergo various study procedures as outlined by the researchers. The study is designed to evaluate not only the clinical benefits but also the pharmacokinetics and tolerability of the treatment regimen.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with non-resectable local advanced or metastatic pancreatic cancer who have not received prior systemic treatment.
Not a fit: Patients with known allergies to the investigational drug components or those with specific genetic mutations such as BRCA1/2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced pancreatic cancer.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating combination therapies for advanced cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female aged 18-75 years old. The subjects must have informed consent to the study, and signed the written informed consent voluntarily. * Diagnosis as non resectable local advanced or metastatic pancreatic cancer by histology or cytology. * Measurable disease as defined by RECIST 1.1. * Without systemic treatment for pancreatic cancer. * ECOG physical strength score 0-2 * Estimated survival time \>=3 months. * The adequate bone marrow fuction and coagulation function Exclusion Criteria: * Known allergy or hypersensitivity to any components of the investigational drug product. * Previous treatment with highly selective inhibitors targeting Colony Stimulating Factor 1 (CSF-1)/Colony Stimulating Factor 1 Receptor (CSF-1R). * With Breast Cancer Gene 1/2 (BRCA1/2) gene mutation. * With a history of other malignancies within 5 years. * During the trial, other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except for local symptomatic radiotherapy) or traditional Chinese medicine must be used for anti-tumor treatment. * With conditions that significantly affected the absorption of oral drug. * Surgical treatment is required within 4 weeks before the first administration, or unhealed, infected, or dehiscence of previous surgical wounds. * During the 2 weeks prior to the first administration of this study, the patient was receiving chronic systemic steroid treatment or any other form of immunosuppressive treatment. * Concomitant use of strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4) within 14 days prior to randomization. * Previous peripheral neuropathy \> grade 1 (Common Terminology Criteria for Adverse Events, version 5.0). * Diagnosed with immune deficiency or interstitial lung disease. * The patients were vaccinated within 4 weeks before the first treatment. * Participated in any drug clinical trial within 4 weeks before the first treatment. * Active central nervous system (CNS) metastases. * Impaired cardiac function or clinically significant cardiac disease. * Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study. * Known active infections from certain viruses, bacteria or parasites. * Patients with refractory/uncontrolled ascites or pleural effusion. * Pregnant or lactating women. * Any other clinically significant comorbidities, which in the judgment of the Investigator, should not be included.
Where this trial is running
Shanghai, Shanghai Municipality and 4 other locations
- Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (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)
Study contacts
- Study coordinator: Yuan Lu
- Email: clinical@abbisko.cn
- Phone: +86-21-68910052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.