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Advanced Pancreatic CancerPhase 2NCT06111274

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

A Phase 2 study testing Pimicotinib (ABSK021) in people with Advanced Pancreatic Cancer, run by Abbisko Therapeutics Co, Ltd at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Pimicotinib (ABSK021)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
5 sitesChina
Study dates
17 Oct 2023to 29 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

YUAN LU contact

+86-21-68910052

clinical@abbisko.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • West China Hospital of Sichuan University

    Chengdu

    Dan Cao

    Dan Cao

    Recruiting

  • Harbin Medical University Cancer Hospital

    Ha’erbin

    Zhiwei Li

    Zhiwei Li

    Recruiting

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

    Liwei Wang

    Liwei Wang

    Recruiting

  • Shanghai East Hospital Tongji University

    Shanghai

    Ming Quan

    Ming Quan

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of science and technolog

    Wuhan

    Tao Zhang

    Tao Zhang

    Recruiting

Other trials in China

About this study

Official title: 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

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.
Read more

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.
Read the 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.

Being tested
Pimicotinib (ABSK021)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pimicotinib (ABSK021)Drug

    Also called Gemcitabine, nab-Pacilitaxel, Toripalimab

    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.

Study groups in NCT06111274
Study groupRoleWhat they receive
ABSK021 with chemotherapyExperimentalThere 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.
Receives: Drug: Pimicotinib (ABSK021)
ABSK021 in combination with chemotherapy plus the ToripalimabExperimentalThere 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.
Receives: Drug: Pimicotinib (ABSK021)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Event Occurance

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

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

  2. 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)

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

Secondary outcomes (6)

  1. Duration of Response

    Duration of response (DOR) is defined as the time from the date of the first documentation of confirmed response (Complete Response or Partial Response) to the first objective documentation of progressive disease (PD) per RECIST v1.1 per Investigator assessment, or to death due to any cause in the absence of documented PD.

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

  2. Progression Free Survival

    Progression-free survival (PFS) was defined as as the time from the first dose to the first objectively documented disease progression per RECIST v1.1 per Investigator assessment, or death due to any cause in the absence of documented progressive disease (PD). PFS was analyzed using Kaplan-Meier methods.

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

  3. Overall Survival

    Overall survival (OS) was defined as the time from first dose of study drug to death due to any cause. OS was calculated using the Kaplan-Meier method.

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

  4. The exposure of ABSK021

    The Area Under the Concentration Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Normalized by Dose.

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

  5. The Maximum Concentration of ABSK021

    Maximum Observed Concentration (Cmax)

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

  6. The Minimum Concentration of ABSK021

    Minimum Observed Concentration (Cmin)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start17 Oct 2023
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion29 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111274
Sponsor's protocol ID
ABSK021-202
Status last verified
Apr 2024
First submitted
20 Oct 2023
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pimicotinib (ABSK021) in people with Advanced Pancreatic Cancer, run by Abbisko Therapeutics Co, Ltd at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact YUAN LU (+86-21-68910052, clinical@abbisko.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Event Occurance (time frame: From the day signed informed consent form to day 90 after the end of cycle 8 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06111274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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