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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04565275
• Other study ID #: ICP-CL-00303
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2021
• Est. completion date: April 15, 2024

Study information

• Verified date: March 2023
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: Olivia Yang
• Phone: +1 (609) 524-0684
• Email: olivia.yang[@]INNOCAREPHARMA.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 15, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Cholangiocarcinoma
• Urothelial Carcinoma

Intervention

Drug:
• Drug ICP-192
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 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.

Locations

Country	Name	City	State
Australia	Pindara Private Hospital	Benowa	Queensland
Australia	Monash Medical Centre Clayton	Clayton	Victoria
Australia	Peninsula & South Eastern Haematology & Oncology Group	Frankston	Victoria
Australia	Macquarie University Hospital	Macquarie Park	New South Wales
Australia	Olivia Newton-John Cancer Research Institute	Melbourne	Victoria
Australia	GenesisCare - North Shore	St Leonards	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	Rutgers Cancer Institute of New Jersey	Bronx	New York
United States	The Ohio State University	Columbus	Ohio
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of California, San Diego (UCSD) - Moores Cancer Center	La Jolla	California
United States	Clinical Research Alliance	Lake Success	New York
United States	Minnesota Oncology Hematology	Minneapolis	Minnesota
United States	Mid Florida Hematology and Oncology	Orange City	Florida
United States	Arizona Oncology	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug exposure	Phase II: Dose Expansion Assessment of the correlations between drug exposure (e.g., AUC, Cmax) and patient response to ICP-192.	Up to 3 years
Other	PD biomarker	Phase II: Dose Expansion Assessment of the correlations between PD biomarker and patient response to ICP-192.	Up to 3 years
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Phase I: Dose Escalation & Phase II: Dose Expansion To evaluate the safety and tolerability of different doses of ICP-192 in patients with advanced solid tumors	Up to 3 years
Primary	MTD	Phase I: Dose Escalation To determine Maximum Tolerated Dose(MTD) for ICP-192	Up to 3 years
Primary	OBD	Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192	Up to 3 years
Primary	RP2D	Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192	Up to 3 years
Primary	ORR	Phase II: Dose Expansion Objective Response Rate	Up to 3 years
Secondary	Peak concentration (Cmax)	Phase I: Dose Escalation Peak concentration (Cmax)	Up to 3 years
Secondary	AUC	Phase I: Dose Escalation AUC	Up to 3 years
Secondary	DCR	Phase II: Dose Expansion disease control rate	Up to 3 years
Secondary	DOR	Phase II: Dose Expansion duration of response	Up to 3 years
Secondary	PFS	Phase II: Dose Expansion progression-free survival	Up to 3 years
Secondary	OS	Phase II: Dose Expansion overall survival	Up to 3 years