Evaluating Pimicotinib with Chemotherapy for Advanced Pancreatic Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.