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

INTRODUCTION

  • Org Study ID: ICP-CL-00303
  • Secondary ID: N/A
  • NTC ID: NCT04565275
  • Sponsor: 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.

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).

  • Overall Status
    Recruiting
  • Start Date
    February 1, 2021
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Primary Outcome 1 - Timeframe: Up to 3 years

Primary Outcome 2 - Measure: MTD

Primary Outcome 2 - Timeframe: Up to 3 years

Primary Outcome 3 - Measure: OBD

Primary Outcome 3 - Timeframe: Up to 3 years

Primary Outcome 4 - Measure: RP2D

Primary Outcome 4 - Timeframe: Up to 3 years

Primary Outcome 5 - Measure: ORR

Primary Outcome 5 - Timeframe: Up to 3 years

CONDITION

  • Advanced Solid Tumors
  • Urothelial Carcinoma
  • Cholangiocarcinoma

ELIGIBILITY

Major Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits;

- 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;

- 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;

- Phase II: Existing test reports have confirmed the FGFR gene alteration or the central laboratory has detected the FGFR gene alteration.

- Age ≥18 years old;

- At least one measurable lesion according to the Response Evaluation Criteria of Solid Tumor, version 1.1 (RECIST 1.1);

- ECOG performance status of 0-1;

- 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:
Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors;

- Within 2 weeks before the first dose of study drug, the subject's phosphate level continuing to exceed the ULN despite medical treatment;

- Patients with clinically significant gastrointestinal dysfunction

- Has known central nervous system metastases;

- Has a history of or currently uncontrolled cardiovascular diseases

- History of organ transplantation or a history of allogeneic hematopoietic stem cell transplantation;

- Current evidence of corneal or retinal abnormalities that may increase eye toxicity;

- Active hepatitis B virus active hepatitis C, or HIV infection;

- Has not recovered from reversible toxicity of prior anti-tumor therapy

- 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

- 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

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: +1 (609) 524-0684

Email: olivia.yang@INNOCAREPHARMA.COM

LOCATION

Facility Status Contact
Facility: Arizona Oncology
Tucson, Arizona 85711
United States
Status: Recruiting Contact: Contact
Sudhir Manda, MD
520-886-0206
Facility: Rocky Mountain Cancer Centers
Aurora, Colorado 80012
United States
Status: Recruiting Contact: Contact
Manojkumar Bupathi

Facility: Mid Florida Hematology and Oncology
Orange City, Florida 32763
United States
Status: Recruiting Contact: Contact
Santosh Nash, MD

Facility: Minnesota Oncology Hematology
Minneapolis, Minnesota 55404
United States
Status: Recruiting Contact: Contact
Diaa Osman