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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-192 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug ICP-192 | Drug |
|
| 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 |
| 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 |
| 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. |
Major Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Participants are excluded from the study if any of the following criteria apply:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivia Yang | Contact | +1 (609) 524-0684 | olivia.yang@INNOCAREPHARMA.COM |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology | Recruiting | Tucson | Arizona | 85711 | United States |
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| 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 |
| Up to 3 years |
| University of California, San Diego (UCSD) - Moores Cancer Center | Recruiting | La Jolla | California | 92037 | United States |
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| Rocky Mountain Cancer Centers | Recruiting | Aurora | Colorado | 80012 | United States |
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| Mid Florida Hematology and Oncology | Not yet recruiting | Orange City | Florida | 32763 | United States |
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| Minnesota Oncology Hematology | Recruiting | Minneapolis | Minnesota | 55404 | United States |
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| Clinical Research Alliance | Recruiting | Lake Success | New York | 11042 | United States |
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| Rutgers Cancer Institute of New Jersey | Recruiting | The Bronx | New York | 10462 | United States |
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| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77001 | United States |
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| Macquarie University Hospital | Recruiting | Macquarie Park | New South Wales | 2109 | Australia |
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| GenesisCare - North Shore | Recruiting | St Leonards | New South Wales | 1590 | Australia |
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| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| Pindara Private Hospital | Recruiting | Benowa | Queensland | 4217 | Australia |
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| Monash Medical Centre Clayton | Recruiting | Clayton | Victoria | 3168 | Australia |
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| Peninsula & South Eastern Haematology & Oncology Group | Recruiting | Frankston | Victoria | 3199 | Australia |
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| Olivia Newton-John Cancer Research Institute | Recruiting | Melbourne | Victoria | 3084 | Australia |
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
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