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

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ClinicalTrials.gov Identifier: NCT04565275
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : February 10, 2021
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 : October 21, 2022
Estimated Study Completion Date : February 16, 2023


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.



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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, Florida
Mid Florida Hematology and Oncology Recruiting
Orange City, Florida, United States, 32763
Contact: Santosh Nash, MD         
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: February 10, 2021
Last Verified: February 2021

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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