A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumours With FGFR2 Alterations
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).
- EligibilityCriteria: 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. Any other diseases or clinical laboratory, etc that may affect the interpretation of the results, or renders the patients at high risk from treatment complications. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult