A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

February 5, 2024 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of ICP-192 in Subjects With Unresectable or Metastatic Intrahepatic Cholangiocarcinoma With FGFR2 Fusions/Rearrangements Who Have Failed Prior Therapy

This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230036
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing, China, 100730
      • Beijing, Beijing, China, 100032
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing, China, 100069
    • Fujian
      • FuZhou, Fujian, China, 350025
        • Not yet recruiting
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
        • Contact:
      • Fujian, Fujian, China, 350011
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Not yet recruiting
        • Foshan First People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Guangzhou, Guangdong, China, 510000
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Not yet recruiting
        • Hebei Medical University Fourth Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
      • Zhengzhou, Henan, China, 450066
        • Not yet recruiting
        • First Affiliated Hospital of Zhengzhou University.
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430079
      • Wuhan, Hubei, China, 430062
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
      • Changsha, Hunan, China, 410002
        • Not yet recruiting
        • Human Provincial People's Hospital
        • Contact:
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • The Third Xiangya Hospital of Central South Uninversity
        • Contact:
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Not yet recruiting
        • Changzhou Tumor Hospital
        • Contact:
      • Jiangyin, Jiangsu, China, 214499
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • The Affiliated Hospital of Nanjing University Meidical School
        • Contact:
      • Suzhou, Jiangsu, China, 215004
        • Not yet recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
      • Xuzhou, Jiangsu, China, 221009
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110042
        • Not yet recruiting
        • LiaoNing Cancer Hospital&Institute
        • Contact:
    • Nanchang
      • Nanchang, Nanchang, China, 330029
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Not yet recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Not yet recruiting
        • Tangdu hospital of the Fourth Military Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250013
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu hospital
        • Contact:
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Affiliated Cancer Hospital of Shandong First Medical University
        • Contact:
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200123
      • Shanghai, Shanghai, China, 200433
        • Not yet recruiting
        • the Third Affiliated Hospital of Naval Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Cancer Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
      • Hangzhou, Zhejiang, China, 310009
      • Hangzhou, Zhejiang, China, 310009
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed the ICF and Age ≥ 18 years old, either sex.
  2. ECOG score of 0-1.
  3. Life expectancy > 3 months.
  4. Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma with unresectable, recurrent or metastatic (AJCC 2017, 8th edition, TNM stage IV) tumor that has progressed following at least one line of chemotherapy and progression/recurrence within 6 months after neoadjuvant/adjuvant chemotherapy may be included.
  5. FGFR2 fusion /rearrangement as confirmed by the central laboratory.
  6. At least one measurable lesion at screening as target lesion per RECIST 1.1.
  7. Organ functions meeting the protocol requirements.
  8. Contraception according to the protocol requirements.

Exclusion Criteria:

  1. Presence of other malignancies requiring medical intervention.
  2. Prior treatment with selective FGFR inhibitors or FGFR antibodies.
  3. Treatment with biological products, radical radiotherapy, and other investigational drugs within 4 weeks prior to the first dose of study drug. Chemotherapy within 3 weeks prior to the first dose of study drug.
  4. Known symptomatic central nervous system (CNS) metastases.
  5. Patients who have not recovered from the toxicity caused by previous anti-tumor treatment and have ≥ Grade 2 adverse events (judged per CTCAE V5.0 evaluation criterion) at the first dose of study drug.
  6. Currently uncontrolled cardiovascular and cerebrovascular diseases, or a past medical history.
  7. Any unstable or uncontrolled systemic disease as judged by the investigator, such as: active infection requiring intravenous therapy, uncontrolled hypertension (After treatment systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg), and diabetes mellitus (HbA1c > 8%).
  8. Current active bleeding, such as deep venous thrombosis, portal hypertension signs leading to gastroesophageal venous bleeding.
  9. Wound with active infection.
  10. Major surgical procedures within 4 weeks prior to the first dose of the study drug or minor surgical procedures within 2 weeks prior to the first dose of the study drug.
  11. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity
  12. History and/or current evidence of extensive tissue calcification, including but not limited to calcification in soft tissues, kidney, intestine, myocardium, vasculature and/or the lungs, with the exception of lymph node calcification, mild pulmonary parenchymal calcification, and asymptomatic coronary artery calcification.
  13. Clinically serious gastrointestinal dysfunction that may affect the intake, transport or absorption of the study drug (such as poorly controlled nausea, vomiting, diarrhea; malabsorption syndrome; intestinal obstruction and small bowel resection, etc.), or the patient was unable to swallow the drug orally.
  14. Active HBV infection, Active HCV infection, HIV infection.
  15. Female subjects who are pregnant or breastfeeding, or plan to have a pregnancy within 6 months after the last dose of the study drug; or male subjects who plan to father a child during the study or within 6 months after the last dose of the study drug.
  16. The last dose of strong CYP3A inhibitor or CYP3A inducer (including food, western medicine, traditional Chinese medicine) is less than 5 half-lives before the first dose of study drug, or plans to take concomitant drugs or foods with strong CYP3A inhibition or induction during the study.
  17. Known allergy to any excipients of the study drug.
  18. Subjects with conditions that in the investigator's opinion are not suitable for participating in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICP-192
Drug: ICP-192
ICP-192 is a round, uncoated tablet, 5mg, orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 3 years
Up to 3 years
Area under the concentration-time curve (AUC)
Time Frame: Up to 3 years
Up to 3 years
Progression-free survival (PFS)
Time Frame: Up to 3 years
Up to 3 years
Disease control rate (DCR)
Time Frame: Up to 3 years
Up to 3 years
Duration of response (DOR)
Time Frame: Up to 3 years
Up to 3 years
Time to response (TTR)
Time Frame: Up to 3 years
Up to 3 years
The adverse event (AE) of ICP-192 assessed by NCI-CTCAE V5.0
Time Frame: Up to 3 years
Up to 3 years
Maximum concentration (Cmax)
Time Frame: Up to 3 years
Up to 3 years
Time to maximum concentration (Tmax)
Time Frame: Up to 3 years
Up to 3 years
Half-life (T1/2)
Time Frame: Up to 3 years
Up to 3 years
Apparent clearance (CL/F)
Time Frame: Up to 3 years
Up to 3 years
Terminal apparent volume of distribution (Vz/F)
Time Frame: Up to 3 years
Up to 3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
To explore the relationship between blood phosphorus and clinical efficacy
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jin Li, Shanghai East Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-CL-00305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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