SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: ICP-192 in Patients With Advanced Solid Tumors and FGFR Gene Alterations

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


  • Org Study ID: ICP-CL-00303
  • Secondary ID:
  • NCT ID: NCT04565275
  • NCT Alias:
  • Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. - Industry
  • Source: 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).

Overal Status Start Date Phase Study Type
Recruiting September 14, 2020 Phase 1/Phase 2 Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: Up to 3 years

Primary Outcome 2 - Measure: MTD

Primary Outcome 2 - Time Frame: Up to 3 years

Primary Outcome 3 - Measure: OBD

Primary Outcome 3 - Time Frame: Up to 3 years

Primary Outcome 4 - Measure: RP2D

Primary Outcome 4 - Time Frame: Up to 3 years

Primary Outcome 5 - Measure: ORR

Primary Outcome 5 - Time Frame: Up to 3 years

Condition:

  • Advanced Solid Tumors
  • Urothelial Carcinoma
  • Cholangiocarcinoma

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.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Olivia Yang

Phone: +1 (609) 524-0684

Email: olivia.yang@INNOCAREPHARMA.COM

Location

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