Clinical trial · Interventional
A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
A First-in-human, Open-label, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors With FGFR2 Alterations, Adult | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3HP-2827 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stage I - dose escalation
- description
- Dose escalation of 3HP-2827 in patients with advanced solid tumors.
- interventionNames
- Drug: 3HP-2827
- type
- EXPERIMENTAL
- label
- Stage II - expansion
- description
- Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I.
- interventionNames
- Drug: 3HP-2827
Primary outcomes (7)
- measure
- Dose Escalation Stage- incidence of adverse events (AEs)
- timeFrame
- From baseline up until 28 days after the final dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available