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3HP-2827 for Solid Tumors with FGFR2 Alterations

This study is testing a new oral drug called 3HP-2827 for adults with solid tumors that have specific changes in a gene called FGFR2. These tumors must be unresectable (cannot be removed by surgery) or metastatic (have spread to other parts of the body). The main goals of this study are to find out how safe 3HP-2827 is, what side effects it might cause, and how well your body handles the drug. Researchers will also look at whether the drug helps to shrink or control the cancer. You may be able to join if you are at least 18 years old, have a solid tumor with FGFR2 alterations, and meet other health requirements. The study is currently unclear about its recruitment status.

Study design
This is a first-in-human study, meaning it's the first time this drug is being tested in people. It plans to enroll about 130 participants in two stages: a dose escalation stage to find the right dose, and an expansion stage.
What's involved
You would take 3HP-2827 by mouth once a day in cycles that last 28 days. The study will monitor for side effects and changes in your vital signs from the start until 28 days after your last dose.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects and changes in vital signs from the beginning of the study until 28 days after your final dose of 3HP-2827.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06287918

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
3H (Suzhou) Pharmaceuticals Co., Ltd.
~130 participants
Updated 2026-01-27 on ClinicalTrials.gov
What's tested:3HP-2827

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation Stage- incidence of adverse events (AEs)
Measured over From baseline up until 28 days after the final dose
+6 more outcomes measured

Conditions

Solid Tumors With FGFR2 Alterations, Adult

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Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Phoenix, Arizonano site contact published

  • The University of Texas MD Anderson Cancer Center

    Houston, Texasno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Shuchao Wu
[email protected]
+86-21-50895559
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Dose Escalation Stage- incidence of adverse events (AEs)From baseline up until 28 days after the final dose
  • Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs)Days 1-28 of Cycle 1 (a cycle is 28 days)
  • Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital SignsFrom baseline up until 28 days after the final dose
  • Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test ResultsFrom baseline up until 28 days after the final dose
  • Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG ParametersFrom baseline up until 28 days after the final dose
  • Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827Initiation of study drug until study discontinuation, (up to approximately 24 months)
  • Expansion stage -Objective response rate（ORR）Initiation of study drug until disease progression (up to approximately 36 months)