A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer

NCT06111274 | Recruiting Phase 2

• 1 other identifier: ABSK021-202
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (2)

• Safety Event Occurance

  The Number of Participants With Adverse Event (AE), a Serious Adverse Event (SAE) and Dose Limiting Toxicities (DLT) Event.

  From the day signed informed consent form to day 90 after the end of cycle 8 (each cycle is 21 days)

• Objective Response Rate (ORR)

  The Percentage of Participants with confirmed Complete Response and Partial Response, in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

  From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)

Secondary Outcomes (6)

• Duration of Response

  From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)

• Progression Free Survival

  From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)

• Overall Survival

  From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)

• The exposure of ABSK021

  From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)

• The Maximum Concentration of ABSK021

  From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)

Study Arms (2)

ABSK021 with chemotherapy

EXPERIMENTAL

There are 2 cohorts in both part A and Part B. In cohort 1, the participant will receive the treatment of ABSK021 in combination with chemotherapy (the Gemcitabine and nab-Pacilitaxel) , 3 weeks as one cycle, about 8 cycles in total.

Drug: Pimicotinib (ABSK021)

ABSK021 in combination with chemotherapy plus the Toripalimab

EXPERIMENTAL

There are 2 cohorts in both part A and Part B. In cohort 2, the participant will receive the treatment of ABSK021 in combination with chemotherapy (the Gemcitabine and nab-Pacilitaxel), with Toripalimab, 3 weeks as one cycle, about 8 cycles in total.

Drug: Pimicotinib (ABSK021)

Interventions

Pimicotinib (ABSK021) DRUG

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.

Also known as: Gemcitabine, nab-Pacilitaxel, Toripalimab

ABSK021 in combination with chemotherapy plus the Toripalimab; ABSK021 with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (5)

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

MeSH Terms

Interventions

Gemcitabine; toripalimab

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

YUAN LU

CONTACT

+86-21-68910052; clinical@abbisko.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 1, 2023
• Study Start: October 17, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 29, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)