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Status unknownNCT04565275Updated Mar 14, 2023

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

A Phase 1/2 interventional study of Drug ICP-192 in Advanced Solid Tumors, Urothelial Carcinoma and Cholangiocarcinoma, sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. Status unknown at 16 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Beijing InnoCare Pharma Tech Co., Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the detailed 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).

02

Conditions studied

  • Advanced Solid Tumors
  • Urothelial Carcinoma
  • Cholangiocarcinoma

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03

In context

Cholangiocarcinoma

913 studies on the registry are indexed under Cholangiocarcinoma; 285 are open to participants now.

This study's planned enrollment of 45 is close to the median of 50 across 686 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd. is the lead sponsor of 57 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    ICP-192

    1. Dose Escalation Phase ICP-192 2. Dose Expansion Phase ICP-192

    Drug: Drug ICP-192

Interventions

  • DrugDrug ICP-192

    1. Dose Escalation Phase ICP-192 will be taken by patients with advanced solid tumor and will be treated follow the "3+3" dose escalation scheme 2. Dose Expansion Phase ICP-192 will be taken by patients with urothelial carcinoma or cholangiocarcinoma with FGFR gene alterations and will be treated at a single dose defined from the Dose Escalation Phase.

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What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Phase I: Dose Escalation \& Phase II: Dose Expansion To evaluate the safety and tolerability of different doses of ICP-192 in patients with advanced solid tumors

    Time frame: Up to 3 years

  2. MTD

    Phase I: Dose Escalation To determine Maximum Tolerated Dose(MTD) for ICP-192

    Time frame: Up to 3 years

  3. OBD

    Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192

    Time frame: Up to 3 years

  4. RP2D

    Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192

    Time frame: Up to 3 years

  5. ORR

    Phase II: Dose Expansion Objective Response Rate

    Time frame: Up to 3 years

Secondary outcomes

  1. Peak concentration (Cmax)

    Phase I: Dose Escalation Peak concentration (Cmax)

    Time frame: Up to 3 years

  2. AUC

    Phase I: Dose Escalation AUC

    Time frame: Up to 3 years

  3. DCR

    Phase II: Dose Expansion disease control rate

    Time frame: Up to 3 years

  4. DOR

    Phase II: Dose Expansion duration of response

    Time frame: Up to 3 years

  5. PFS

    Phase II: Dose Expansion progression-free survival

    Time frame: Up to 3 years

  6. OS

    Phase II: Dose Expansion overall survival

    Time frame: Up to 3 years

Other outcomes

  1. Drug exposure

    Phase II: Dose Expansion Assessment of the correlations between drug exposure (e.g., AUC, Cmax) and patient response to ICP-192.

    Time frame: Up to 3 years

  2. PD biomarker

    Phase II: Dose Expansion Assessment of the correlations between PD biomarker and patient response to ICP-192.

    Time frame: Up to 3 years

07

Study locations

15 of 16 sites recruiting
  • Arizona Oncology
    Tucson, Arizona 85711, United States
    • Sudhir Manda, MD · Contact · 520-886-0206
    Recruiting
  • University of California, San Diego (UCSD) - Moores Cancer Center
    La Jolla, California 92037, United States
    • Shumei Kato · Contact
    Recruiting
  • Rocky Mountain Cancer Centers
    Aurora, Colorado 80012, United States
    • Manojkumar Bupathi · Contact
    Recruiting
  • Mid Florida Hematology and Oncology
    Orange City, Florida 32763, United States
    • Santosh Nair, MD · Contact
    Not yet recruiting
  • Minnesota Oncology Hematology
    Minneapolis, Minnesota 55404, United States
    • Timothy Larson · Contact
    Recruiting
  • Rutgers Cancer Institute of New Jersey
    Bronx, New York 10462, United States
    • Sanjay Goel · Contact
    Recruiting
  • Clinical Research Alliance
    Lake Success, New York 11042, United States
    • James D'Olimpio · Contact
    Recruiting
  • The Ohio State University
    Columbus, Ohio 43210, United States
    • Sameek Roychowdhury · Contact
    Recruiting
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77001, United States
    • Neal Akhave · Contact
    Recruiting
  • Macquarie University Hospital
    Macquarie Park, New South Wales 2109, Australia
    • Alison Zhang · Contact
    Recruiting
  • GenesisCare - North Shore
    St Leonards, New South Wales 1590, Australia
    • Adrian Lee · Contact
    Recruiting
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
    • Ka Yeung Mark Wong · Contact
    Recruiting
  • Pindara Private Hospital
    Benowa, Queensland 4217, Australia
    • Marco Matos · Contact
    Recruiting
  • Monash Medical Centre Clayton
    Clayton, Victoria 3168, Australia
    • Elizabeth Ahern · Contact
    Recruiting
  • Peninsula & South Eastern Haematology & Oncology Group
    Frankston, Victoria 3199, Australia
    • Vinod Ganju · Contact
    Recruiting
  • Olivia Newton-John Cancer Research Institute
    Melbourne, Victoria 3084, Australia
    • Andrew Weickhardt · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04565275
Lead sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Responsible party
Sponsor
First posted
Sep 25, 2020
Start date
Feb 1, 2021
Primary completion
Nov 30, 2023 (estimated)
Completion
Apr 15, 2024 (estimated)
Last update
Mar 14, 2023

Study contacts

Olivia Yang
Contact
olivia.yang@INNOCAREPHARMA.COM
+1 (609) 524-0684

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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