Clinical trial NCT04565275: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Urothelial Carcinoma
Cholangiocarcinoma
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 3 years
measure: MTD
timeFrame: Up to 3 years
measure: OBD
timeFrame: Up to 3 years
measure: RP2D
timeFrame: Up to 3 years
measure: ORR
timeFrame: Up to 3 years
Secondary outcomes:
measure: Peak concentration (Cmax)
timeFrame: Up to 3 years
measure: AUC
timeFrame: Up to 3 years
measure: DCR
timeFrame: Up to 3 years
measure: DOR
timeFrame: Up to 3 years
measure: PFS
timeFrame: Up to 3 years
measure: OS
timeFrame: Up to 3 years
Other outcomes:
measure: Drug exposure
timeFrame: Up to 3 years
measure: PD biomarker
timeFrame: Up to 3 years
Locations:
city: Tucson
country: United States
facility: Arizona Oncology
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego (UCSD) - Moores Cancer Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology
state: Florida
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Bronx
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New York
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare - North Shore
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Benowa
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Centre Clayton
state: Victoria
city: Frankston
country: Australia
facility: Peninsula & South Eastern Haematology & Oncology Group
state: Victoria
city: Melbourne
country: Australia
facility: Olivia Newton-John Cancer Research Institute
state: Victoria
Study officials:
References: