NCT06378593 A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
| NCT ID | NCT06378593 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | 3H (Suzhou) Pharmaceuticals Co., Ltd. |
| Condition | Solid Tumors With FGFR2 Alterations, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2028-06-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2024-06-17 with a primary completion date of 2028-06-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 unsuitable for participation in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06378593 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors With FGFR2 Alterations, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06378593 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06378593 currently recruiting?
Yes, NCT06378593 is actively recruiting participants. Contact the research team at shuchao.wu@3hpharma.com for enrollment information.
Where is the NCT06378593 trial being conducted?
This trial is being conducted at Beijing, China, Shanghai, China.
Who is sponsoring the NCT06378593 clinical trial?
NCT06378593 is sponsored by 3H (Suzhou) Pharmaceuticals Co., Ltd.. The trial plans to enroll 130 participants.