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Recruiting Phase 1, Phase 2 NCT06378593

A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

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Trial Parameters

Condition Solid Tumors With FGFR2 Alterations, Adult
Sponsor 3H (Suzhou) Pharmaceuticals Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 130
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-17
Completion 2028-06-16
Interventions
3HP-2827

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol * Men or women, age ≥ 18 years at the time of signing informed consent. * Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor. * ECOG score is 0 or 1. * An expected survival of ≥ 12 weeks. * Evaluable or measurable disease per RECIST v1.1. * Adequate organ function, as measured by laboratory values. Exclusion Criteria: * Active brain metastases. * Have other malignancies within the past 3 years. * The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1. * Clinically significant corneal or retinal disease/keratopathy. * Clinically significant cardiovascular disorders. * Failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption. * Known to be allergic to any study drug or any of its excipients. * Assessed by the investigator to be uns

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