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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • 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 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
        • Not yet recruiting
        • Shulan（Hangzhou） Hospital
        • Contact:
      • 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

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
Intervention / Treatment
Experimental: ICP-192
Drug: ICP-192
ICP-192 is a round, uncoated tablet, 5mg, orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

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

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

Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

  • 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)

November 15, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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