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This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Dose Escalation | Experimental | Multiple doses of CGT4859 for oral administration |
|
| Phase 2: Signal Seeking | Experimental | Oral dose of CGT4859 at the RP2D as determined in Phase 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGT4859 | Drug | CGT4859 is a selective FGFR2/3 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs | Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification | Approximately 12 months |
| Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - Laboratory results | Clinically significant changes or abnormalities observed from baseline in laboratory results in chemistry, hematology, and coagulation parameters | Approximately 12 months |
| Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - ECG results | Clinically significant changes or abnormalities observed from baseline in electrocardiogram (ECG) parameters | Approximately 12 months |
| Phase 2: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR) | Approximately 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Pharmacokinetics | Plasma concentration levels of CGT4859 | Approximately 28 days |
| Phase 1: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR) | Approximately 8 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Palo Alto | California | 94305 | United States | ||
| Mayo Clinic Jacksonville |
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Phase 1 will evaluate multiple ascending doses until the highest safe dose and the recommended phase 2 dose (RP2D) are determined.
Phase 2 will evaluate the RP2D in 4 cohorts defined by tumor type and prior therapy based on Phase 1 results.
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| Phase 1 and Phase 2: Evaluate antitumor activity of CGT4859 - Disease Control Rate (DCR) | Approximately 8 months |
| Phase 2: Characterize the safety of CGT4859 - AEs | Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification | Approximately 9 months |
| Phase 2: Characterize the safety of CGT4859 - Labs, ECG | Changes from baseline in key laboratory results and electrocardiogram (ECG) parameters | Approximately 9 months |
| Phase 2: Pharmacokinetics at RP2D | Plasma concentration levels of CGT4859 | Approximately 28 days |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University of Chicago Medicine Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Taussig Cancer Center - Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Fox Chase cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute - University of Utah | Salt Lake City | Utah | 84112 | United States |
| Princess Margaret Cancer Centre - UHN | Toronto | Ontario | M5G 2C4 | Canada |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| C562580 | Cirrhosis, Familial, with Pulmonary Hypertension |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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