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

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

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 unsuitable for participation in this study.

Conditions2

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