Recruiting
Phase 1
Phase 2

ICP-192

Sponsor:

Beijing InnoCare Pharma Tech Co., Ltd.

Code:

NCT04565275

Conditions

Advanced Solid Tumors

Urothelial Carcinoma

Cholangiocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Drug ICP-192

Study Details

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.

Conditions

Advanced Solid Tumors

Urothelial Carcinoma

Cholangiocarcinoma

Study ID

NCT04565275

Start date

Feb 1, 2021

Status verified date

Mar, 2023

Completion date

Apr 15, 2024

Anticipated

Primary completion date

Nov 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ICP-192

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

Interventions

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 measure

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 3 years ]
  • MTD [ Time Frame: Up to 3 years ]
  • OBD [ Time Frame: Up to 3 years ]
  • RP2D [ Time Frame: Up to 3 years ]
  • ORR [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Locations

Arizona Oncology

Recruiting

Tucson, Arizona, United States, 85711

Contacts

Sudhir Manda, MD

520-886-0206

University of California, San Diego (UCSD) - Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

Rocky Mountain Cancer Centers

Recruiting

Aurora, Colorado, United States, 80012

Minnesota Oncology Hematology

Recruiting

Minneapolis, Minnesota, United States, 55404

Rutgers Cancer Institute of New Jersey

Recruiting

Bronx, New York, United States, 10462

Clinical Research Alliance

Recruiting

Lake Success, New York, United States, 11042

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77001

More Information

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Last update posted

Mar 14, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Beijing InnoCare Pharma Tech Co., Ltd. on 2023-03-14.