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

NCT04565275 | Unknown Phase 1 FDA Drug

• 1 other identifier: ICP-CL-00303
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 16

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.

Conditions

Advanced Solid Tumors; Urothelial Carcinoma; Cholangiocarcinoma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Peak concentration (Cmax)

  Up to 3 years

• AUC

  Up to 3 years

• DCR

  Up to 3 years

• DOR

  Up to 3 years

• PFS

  Up to 3 years

Other Outcomes (2)

• Drug exposure

  Up to 3 years

• PD biomarker

  Up to 3 years

Study Arms (1)

ICP-192

EXPERIMENTAL

1. Dose Escalation Phase ICP-192 2. Dose Expansion Phase ICP-192

Drug: Drug ICP-192

Interventions

Drug ICP-192 DRUG

1. 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 2. 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.

ICP-192

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (16)

Arizona Oncology

Tucson, Arizona, 85711, United States

RECRUITING

University of California, San Diego (UCSD) - Moores Cancer Center

La Jolla, California, 92037, United States

RECRUITING

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012, United States

RECRUITING

Mid Florida Hematology and Oncology

Orange City, Florida, 32763, United States

NOT YET RECRUITING

Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States

RECRUITING

Clinical Research Alliance

Lake Success, New York, 11042, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

The Bronx, New York, 10462, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77001, United States

RECRUITING

Macquarie University Hospital

Macquarie Park, New South Wales, 2109, Australia

RECRUITING

GenesisCare - North Shore

St Leonards, New South Wales, 1590, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Pindara Private Hospital

Benowa, Queensland, 4217, Australia

RECRUITING

Monash Medical Centre Clayton

Clayton, Victoria, 3168, Australia

RECRUITING

Peninsula & South Eastern Haematology & Oncology Group

Frankston, Victoria, 3199, Australia

RECRUITING

Olivia Newton-John Cancer Research Institute

Melbourne, Victoria, 3084, Australia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma

Central Study Contacts

Olivia Yang

CONTACT

+1 (609) 524-0684; olivia.yang@INNOCAREPHARMA.COM

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 25, 2020
• Study Start: February 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: April 15, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

AU (7); US (9)