Treatment of advanced solid tumors with FGFR2 alterations using 3HP-2827
An Open-Label, Multi-center Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
This study is testing a new drug called 3HP-2827 to see if it can help adults with advanced solid tumors that have FGFR2 changes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | 3H (Suzhou) Pharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06378593 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of a new drug, 3HP-2827, in patients with unresectable or metastatic solid tumors that have FGFR2 alterations. It is designed for adults aged 18 and older who have confirmed advanced cancer and meet specific health criteria. Participants will receive the treatment while being monitored for their response and any side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unresectable or metastatic solid tumors that have FGFR2 alterations.
Not a fit: Patients with active brain metastases or significant cardiovascular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.
How similar studies have performed: Other studies targeting FGFR2 alterations have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
- ZhongShan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shuchao Wu
- Email: shuchao.wu@3hpharma.com
- Phone: +86-21-50895559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.