Overview
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.