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

Brief Title

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

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

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 Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Peak concentration (Cmax)

Condition

Advanced Solid Tumors

Intervention

Drug ICP-192

Study Arms / Comparison Groups

 ICP-192

Description:  Dose Escalation Phase ICP-192
Dose Expansion Phase ICP-192

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

February 1, 2021

Completion Date

April 15, 2024

Primary Completion Date

November 30, 2023

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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +1 (609) 524-0684, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT04565275

Organization ID

ICP-CL-00303

Responsible Party

Sponsor

Study Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Study Sponsor

, ,

Verification Date

March 2023