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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors; Cholangiocarcinoma; Urothelial Carcinoma
• Intervention / Treatment: Drug: Drug ICP-192

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).

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Olivia Yang; Phone Number: +1 (609) 524-0684; Email: olivia.yang@INNOCAREPHARMA.COM

Study Locations

• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Recruiting
      • Macquarie University Hospital
      • Contact: Alison Zhang
    • St Leonards, New South Wales, Australia, 1590
      • Recruiting
      • GenesisCare - North Shore
      • Contact: Adrian Lee
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Contact: Ka Yeung Mark Wong
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Recruiting
      • Pindara Private Hospital
      • Contact: Marco Matos
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Medical Centre Clayton
      • Contact: Elizabeth Ahern
    • Frankston, Victoria, Australia, 3199
      • Recruiting
      • Peninsula & South Eastern Haematology & Oncology Group
    • Melbourne, Victoria, Australia, 3084
      • Recruiting
      • Olivia Newton-John Cancer Research Institute
      • Contact: Andrew Weickhardt
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Recruiting
      • Arizona Oncology
      • Contact: Sudhir Manda, MD; Phone Number: 520-886-0206
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • University of California, San Diego (UCSD) - Moores Cancer Center
      • Contact: Shumei Kato
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Recruiting
      • Rocky Mountain Cancer Centers
      • Contact: Manojkumar Bupathi
  • Florida
    • Orange City, Florida, United States, 32763
      • Not yet recruiting
      • Mid Florida Hematology and Oncology
      • Contact: Santosh Nair, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Minnesota Oncology Hematology
      • Contact: Timothy Larson
  • New York
    • Bronx, New York, United States, 10462
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Sanjay Goel
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Clinical Research Alliance
      • Contact: James D'Olimpio
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Sameek Roychowdhury
  • Texas
    • Houston, Texas, United States, 77001
      • Recruiting
      • The University of Texas Md Anderson Cancer Center
      • Contact: Neal Akhave

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICP-192; Dose Escalation Phase ICP-192; Dose Expansion Phase ICP-192	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
MTD	Phase I: Dose Escalation To determine Maximum Tolerated Dose（MTD) for ICP-192	Up to 3 years
OBD	Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192	Up to 3 years
RP2D	Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192	Up to 3 years
ORR	Phase II: Dose Expansion Objective Response Rate	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration (Cmax)	Phase I: Dose Escalation Peak concentration (Cmax)	Up to 3 years
AUC	Phase I: Dose Escalation AUC	Up to 3 years
DCR	Phase II: Dose Expansion disease control rate	Up to 3 years
DOR	Phase II: Dose Expansion duration of response	Up to 3 years
PFS	Phase II: Dose Expansion progression-free survival	Up to 3 years
OS	Phase II: Dose Expansion overall survival	Up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
PD biomarker	Phase II: Dose Expansion Assessment of the correlations between PD biomarker and patient response to ICP-192.	Up to 3 years

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): April 15, 2024

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: ICP-CL-00303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No