A Study of ICP-192 in Patients With Advanced Solid Tumors

Last updated: March 12, 2023
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Liver Cancer

Urothelial Carcinoma

Abdominal Cancer

Treatment

N/A

Clinical Study ID

NCT04565275
ICP-CL-00303
  • Ages > 18
  • All Genders

Study Summary

This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dose escalation and Part II (Phase II), dose expansion.

Eligibility Criteria

Inclusion

Major Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits;

  2. Phase I: Patients with histologically or cytologically confirmed unresectable or metastatic advanced malignant solid tumors who have progressed under standard treatment or recurred after or were intolerant to all standard treatment regimens, or have no standard treatment available;

  3. Phase II: patients with histologically or cytologically confirmed unresectable or metastatic urothelial carcinoma or cholangiocarcinoma, who have progressed or recurred after or were intolerant to first-line chemotherapy, or have progressed/relapsed within 12 months after neoadjuvant /adjuvant chemotherapy;

  4. Phase II: Existing test reports have confirmed the FGFR gene alteration or the central laboratory has detected the FGFR gene alteration.

  5. Age ≥18 years old;

  6. At least one measurable lesion according to the Response Evaluation Criteria of Solid Tumor, version 1.1 (RECIST 1.1);

  7. ECOG performance status of 0-1;

  8. Life expectancy for more than 3 months; Must have adequate organ function Major Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

  1. Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors;

  2. Within 2 weeks before the first dose of study drug, the subject's phosphate level continuing to exceed the ULN despite medical treatment;

  3. Patients with clinically significant gastrointestinal dysfunction

  4. Has known central nervous system metastases;

  5. Has a history of or currently uncontrolled cardiovascular diseases

  6. History of organ transplantation or a history of allogeneic hematopoietic stem cell transplantation;

  7. Current evidence of corneal or retinal abnormalities that may increase eye toxicity;

  8. Active hepatitis B virus active hepatitis C, or HIV infection;

  9. Has not recovered from reversible toxicity of prior anti-tumor therapy

  10. Pregnant or lactating women, as well as women with childbearing potential who are unwilling or unable to perform contraception from the screening to 6 months after the last study drug administration; and fertile men who are unwilling or unable to perform contraception from screening to 3months after the last study drug administration

  11. Other conditions considered by the investigator to be inappropriate for participation in this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 45
Study Start date:
February 01, 2021
Estimated Completion Date:
April 15, 2024

Study Description

Part I (Phase I) of the study enrolls patients with advanced solid tumors (9-15 patients); Part II (Phase II) of the study enrolls patients with urothelial carcinoma or cholangiocarcinoma with FGFR genetic alterations (30 patients).

Connect with a study center

  • Macquarie University Hospital

    Macquarie Park, New South Wales 2109
    Australia

    Active - Recruiting

  • GenesisCare - North Shore

    St Leonards, New South Wales 1590
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Active - Recruiting

  • Monash Medical Centre Clayton

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Peninsula & South Eastern Haematology & Oncology Group

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • Olivia Newton-John Cancer Research Institute

    Melbourne, Victoria 3084
    Australia

    Active - Recruiting

  • Arizona Oncology

    Tucson, Arizona 85711
    United States

    Active - Recruiting

  • University of California, San Diego (UCSD) - Moores Cancer Center

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • Mid Florida Hematology and Oncology

    Orange City, Florida 32763
    United States

    Site Not Available

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    Bronx, New York 10462
    United States

    Active - Recruiting

  • Clinical Research Alliance

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77001
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.