A Study of ICP-192 in Patients With Advanced Solid Tumors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04565275 |
Recruitment Status :
Recruiting
First Posted : September 25, 2020
Last Update Posted : March 14, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors Urothelial Carcinoma Cholangiocarcinoma | Drug: Drug ICP-192 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 1, 2021 |
Estimated Primary Completion Date : | November 30, 2023 |
Estimated Study Completion Date : | April 15, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: ICP-192
|
Drug: Drug ICP-192
|
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 3 years ]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
- MTD [ Time Frame: Up to 3 years ]Phase I: Dose Escalation To determine Maximum Tolerated Dose(MTD) for ICP-192
- OBD [ Time Frame: Up to 3 years ]Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192
- RP2D [ Time Frame: Up to 3 years ]Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192
- ORR [ Time Frame: Up to 3 years ]Phase II: Dose Expansion Objective Response Rate
- Peak concentration (Cmax) [ Time Frame: Up to 3 years ]Phase I: Dose Escalation Peak concentration (Cmax)
- AUC [ Time Frame: Up to 3 years ]Phase I: Dose Escalation AUC
- DCR [ Time Frame: Up to 3 years ]Phase II: Dose Expansion disease control rate
- DOR [ Time Frame: Up to 3 years ]Phase II: Dose Expansion duration of response
- PFS [ Time Frame: Up to 3 years ]Phase II: Dose Expansion progression-free survival
- OS [ Time Frame: Up to 3 years ]Phase II: Dose Expansion overall survival
- Drug exposure [ Time Frame: Up to 3 years ]Phase II: Dose Expansion Assessment of the correlations between drug exposure (e.g., AUC, Cmax) and patient response to ICP-192.
- PD biomarker [ Time Frame: Up to 3 years ]Phase II: Dose Expansion Assessment of the correlations between PD biomarker and patient response to ICP-192.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Major Inclusion Criteria
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;
- 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:
- 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.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565275
Contact: Olivia Yang | +1 (609) 524-0684 | olivia.yang@INNOCAREPHARMA.COM |
United States, Arizona | |
Arizona Oncology | Recruiting |
Tucson, Arizona, United States, 85711 | |
Contact: Sudhir Manda, MD 520-886-0206 | |
United States, California | |
University of California, San Diego (UCSD) - Moores Cancer Center | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Shumei Kato | |
United States, Colorado | |
Rocky Mountain Cancer Centers | Recruiting |
Aurora, Colorado, United States, 80012 | |
Contact: Manojkumar Bupathi | |
United States, Florida | |
Mid Florida Hematology and Oncology | Not yet recruiting |
Orange City, Florida, United States, 32763 | |
Contact: Santosh Nair, MD | |
United States, Minnesota | |
Minnesota Oncology Hematology | Recruiting |
Minneapolis, Minnesota, United States, 55404 | |
Contact: Timothy Larson | |
United States, New York | |
Rutgers Cancer Institute of New Jersey | Recruiting |
Bronx, New York, United States, 10462 | |
Contact: Sanjay Goel | |
Clinical Research Alliance | Recruiting |
Lake Success, New York, United States, 11042 | |
Contact: James D'Olimpio | |
United States, Ohio | |
The Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Sameek Roychowdhury | |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77001 | |
Contact: Neal Akhave | |
Australia, New South Wales | |
Macquarie University Hospital | Recruiting |
Macquarie Park, New South Wales, Australia, 2109 | |
Contact: Alison Zhang | |
GenesisCare - North Shore | Recruiting |
St Leonards, New South Wales, Australia, 1590 | |
Contact: Adrian Lee | |
Westmead Hospital | Recruiting |
Westmead, New South Wales, Australia, 2145 | |
Contact: Ka Yeung Mark Wong | |
Australia, Queensland | |
Pindara Private Hospital | Recruiting |
Benowa, Queensland, Australia, 4217 | |
Contact: Marco Matos | |
Australia, Victoria | |
Monash Medical Centre Clayton | Recruiting |
Clayton, Victoria, Australia, 3168 | |
Contact: Elizabeth Ahern | |
Peninsula & South Eastern Haematology & Oncology Group | Recruiting |
Frankston, Victoria, Australia, 3199 | |
Contact: Vinod Ganju | |
Olivia Newton-John Cancer Research Institute | Recruiting |
Melbourne, Victoria, Australia, 3084 | |
Contact: Andrew Weickhardt |
Responsible Party: | Beijing InnoCare Pharma Tech Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04565275 |
Other Study ID Numbers: |
ICP-CL-00303 |
First Posted: | September 25, 2020 Key Record Dates |
Last Update Posted: | March 14, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cholangiocarcinoma Neoplasms Adenocarcinoma |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |