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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04565275
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : March 14, 2023
Sponsor:
Information provided by (Responsible Party):
Beijing InnoCare Pharma Tech Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Urothelial Carcinoma Cholangiocarcinoma Drug: Drug ICP-192 Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Open-label, Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-192 in Patients With Advanced Solid Tumors and FGFR Gene Alterations
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : April 15, 2024


Arm Intervention/treatment
Experimental: ICP-192
  1. Dose Escalation Phase ICP-192
  2. Dose Expansion Phase ICP-192
Drug: Drug 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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 3 years ]
    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

  2. MTD [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation To determine Maximum Tolerated Dose(MTD) for ICP-192

  3. OBD [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192

  4. RP2D [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192

  5. ORR [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion Objective Response Rate


Secondary Outcome Measures :
  1. Peak concentration (Cmax) [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation Peak concentration (Cmax)

  2. AUC [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation AUC

  3. DCR [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion disease control rate

  4. DOR [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion duration of response

  5. PFS [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion progression-free survival

  6. OS [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion overall survival


Other Outcome Measures:
  1. Drug exposure [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion Assessment of the correlations between drug exposure (e.g., AUC, Cmax) and patient response to ICP-192.

  2. PD biomarker [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion Assessment of the correlations between PD biomarker and patient response to ICP-192.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565275


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

Locations
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United States, Arizona
Arizona Oncology Recruiting
Tucson, Arizona, United States, 85711
Contact: Sudhir Manda, MD    520-886-0206      
United States, California
University of California, San Diego (UCSD) - Moores Cancer Center Recruiting
La Jolla, California, United States, 92037
Contact: Shumei Kato         
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Aurora, Colorado, United States, 80012
Contact: Manojkumar Bupathi         
United States, Florida
Mid Florida Hematology and Oncology Not yet recruiting
Orange City, Florida, United States, 32763
Contact: Santosh Nair, MD         
United States, Minnesota
Minnesota Oncology Hematology Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Timothy Larson         
United States, New York
Rutgers Cancer Institute of New Jersey Recruiting
Bronx, New York, United States, 10462
Contact: Sanjay Goel         
Clinical Research Alliance Recruiting
Lake Success, New York, United States, 11042
Contact: James D'Olimpio         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Sameek Roychowdhury         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77001
Contact: Neal Akhave         
Australia, New South Wales
Macquarie University Hospital Recruiting
Macquarie Park, New South Wales, Australia, 2109
Contact: Alison Zhang         
GenesisCare - North Shore Recruiting
St Leonards, New South Wales, Australia, 1590
Contact: Adrian Lee         
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Ka Yeung Mark Wong         
Australia, Queensland
Pindara Private Hospital Recruiting
Benowa, Queensland, Australia, 4217
Contact: Marco Matos         
Australia, Victoria
Monash Medical Centre Clayton Recruiting
Clayton, Victoria, Australia, 3168
Contact: Elizabeth Ahern         
Peninsula & South Eastern Haematology & Oncology Group Recruiting
Frankston, Victoria, Australia, 3199
Contact: Vinod Ganju         
Olivia Newton-John Cancer Research Institute Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Andrew Weickhardt         
Sponsors and Collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
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Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04565275    
Other Study ID Numbers: ICP-CL-00303
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type