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The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I - dose escalation | Experimental | Dose escalation of 3HP-2827 in patients with advanced solid tumors. |
|
| Stage II - expansion | Experimental | Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3HP-2827 | Drug | 3HP-2827 will be administered orally once daily in 28-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Stage- incidence of adverse events (AEs) | From baseline up until 28 days after the final dose | |
| Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) | Days 1-28 of Cycle 1 (a cycle is 28 days) | |
| Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs | From baseline up until 28 days after the final dose | |
| Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results | From baseline up until 28 days after the final dose | |
| Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters | From baseline up until 28 days after the final dose | |
| Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827 | Initiation of study drug until study discontinuation, (up to approximately 24 months) | |
| Expansion stage -Objective response rate(ORR) | Initiation of study drug until disease progression (up to approximately 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of 3HP-2827 and/or its major metabolites | Initiation of study drug until study discontinuation(up to 45 months) | |
| Duration of Response (DOR) as assessed by RECIST v1.1 | Up to 45 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuchao Wu | Contact | +86-21-50895559 | shuchao.wu@3hpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| The University of Texas MD Anderson Cancer Center |
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| Progression-free survival (PFS) as assessed by RECIST v1.1 | Up to 45 months |
| Overall survival | Up to 48 months |
| Dose escalation stage - Objective Response Rate (ORR) | Up to 45 months |
| Expansion Stage- incidence of adverse events (AEs) | From baseline up until 28 days after the final dose |
| Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs | From baseline up until 28 days after the final dose |
| Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results | From baseline up until 28 days after the final dose |
| Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters | From baseline up until 28 days after the final dose |
| Houston |
| Texas |
| 77030 |
| United States |