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

Launched by 3H (SUZHOU) PHARMACEUTICALS CO., LTD. · Feb 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called 3HP-2827 for adults with certain types of solid tumors that have changes in a gene called FGFR2. These tumors cannot be surgically removed or have spread to other parts of the body. The study aims to understand how safe and effective this treatment is, as well as how the body processes it. The trial will take place in two parts: the first part will gradually increase the dose to find the right amount, and the second part will focus on more patients to see how well it works.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of an unresectable or metastatic solid tumor. They should also be in generally good health, with a performance status score of 0 or 1, meaning they are fully active or only slightly restricted. Patients should expect to provide written consent, attend regular visits for monitoring, and undergo tests throughout the study. It’s important to note that certain health issues, like active brain metastases or significant heart problems, may prevent someone from participating in this trial. If you’re interested or think you might qualify, it’s a good idea to discuss this with your healthcare provider.

Gender

ALL

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.
• • 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.