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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.
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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. |
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| Stage II - expansion | Experimental | Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3HP-2827 | Drug | 3HP-2827 will be administered orally once daily in 28-day cycles. |
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| 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） | ORR refers to the percentage of patients with best overall response of confirmed CR or PR from the start of study treatment to patient withdrawal due to PD. | Initiation of study drug until disease progression (up to approximately 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) | |
| Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy. |
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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 |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Initiation of study drug until study discontinuation, (up to approximately 24 months)) |
| Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) |
| Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) |
| Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) |
| Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) |
| Duration of Response (DOR) as assessed by RECIST v1.1 | DOR refers to the time period from the first evaluation of confirmed CR or PR (whichever occurs first) to PD or death. | Up to 45 months |
| Disease control rate (DCR) as assessed by RECIST v1.1 | DCR refers to the percentage of patients with best overall response of confirmed CR, PR or SD from the start of study treatment to patient withdrawal due to PD. | Up to 45 months |
| Progression-free survival (PFS) as assessed by RECIST v1.1 | PFS refers to the time between the date of first dose and the first PD or death due to any cause based on the investigator's imaging review results | Up to 45 months |
| Overall survival (OS) | OS refers to the time from the date of first dose to the date of death due to any cause. | Up to 48 months |
| Dose escalation stage - Objective Response Rate (ORR) | ORR refers to the percentage of patients with best overall response of confirmed CR or PR from the start of study treatment to patient withdrawal due to PD. | 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 |
| Expansion Stage -Changes in patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer Core QoL Questionnaire (EORTC QLQ-C30) in patients with advanced solid tumors | From baseline up until 28 days after the final dose |
| ZhongShan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200123 | China |
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