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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 : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Beijing InnoCare Pharma Tech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 1, 2020
First Posted Date  ICMJE September 25, 2020
Last Update Posted Date February 1, 2022
Actual Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date October 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
  • 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
  • MTD [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation To determine Maximum Tolerated Dose(MTD) for ICP-192
  • OBD [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192
  • RP2D [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192
  • ORR [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion Objective Response Rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
  • Peak concentration (Cmax) [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation Peak concentration (Cmax)
  • AUC [ Time Frame: Up to 3 years ]
    Phase I: Dose Escalation AUC
  • DCR [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion disease control rate
  • DOR [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion duration of response
  • PFS [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion progression-free survival
  • OS [ Time Frame: Up to 3 years ]
    Phase II: Dose Expansion overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 21, 2020)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of ICP-192 in Patients With Advanced Solid Tumors
Official Title  ICMJE 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
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors
  • Urothelial Carcinoma
  • Cholangiocarcinoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: ICP-192
  1. Dose Escalation Phase ICP-192
  2. Dose Expansion Phase ICP-192
Intervention: Drug: Drug ICP-192
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2020)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 16, 2023
Estimated Primary Completion Date October 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Olivia Yang +1 (609) 524-0684 olivia.yang@INNOCAREPHARMA.COM
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04565275
Other Study ID Numbers  ICMJE ICP-CL-00303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Beijing InnoCare Pharma Tech Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beijing InnoCare Pharma Tech Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing InnoCare Pharma Tech Co., Ltd.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP