A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
NCT ID: NCT06287918
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
130 participants
INTERVENTIONAL
2025-06-30
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Stage I - dose escalation
Dose escalation of 3HP-2827 in patients with advanced solid tumors.
3HP-2827
3HP-2827 will be administered orally once daily in 28-day cycles.
Stage II - expansion
Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I.
3HP-2827
3HP-2827 will be administered orally once daily in 28-day cycles.
Interventions
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3HP-2827
3HP-2827 will be administered orally once daily in 28-day cycles.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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3H (Suzhou) Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Phoenix, Arizona, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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3HP-2827-101
Identifier Type: -
Identifier Source: org_study_id