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Not yet recruiting NCT06287918

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

Phase I Interventional Solid Tumors With FGFR2 Alterations, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3HP-2827.
Who it may be relevant to
Registry conditions: Solid Tumors With FGFR2 Alterations, Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug 3HP-2827
    3HP-2827 will be administered orally once daily in 28-day cycles.

Primary outcome measures

  • Dose Escalation Stage- incidence of adverse events (AEs) [Time frame: From baseline up until 28 days after the final dose]
  • Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) [Time frame: Days 1-28 of Cycle 1 (a cycle is 28 days)]
  • Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs [Time frame: From baseline up until 28 days after the final dose]
  • Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results [Time frame: From baseline up until 28 days after the final dose]
  • Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters [Time frame: From 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-2827 [Time frame: Initiation of study drug until study discontinuation, (up to approximately 24 months)]
  • Expansion stage -Objective response rate（ORR） [Time frame: Initiation of study drug until disease progression (up to approximately 36 months)]
Secondary outcome measures (9)
  • Plasma Concentration of 3HP-2827 and/or its major metabolites [Time frame: Initiation of study drug until study discontinuation（up to 45 months）]
  • Duration of Response (DOR) as assessed by RECIST v1.1 [Time frame: Up to 45 months]
  • Progression-free survival (PFS) as assessed by RECIST v1.1 [Time frame: Up to 45 months]
  • Overall survival [Time frame: Up to 48 months]
  • Dose escalation stage - Objective Response Rate (ORR) [Time frame: Up to 45 months]
  • Expansion Stage- incidence of adverse events (AEs) [Time frame: From baseline up until 28 days after the final dose]
  • Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs [Time frame: From baseline up until 28 days after the final dose]
  • Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results [Time frame: From baseline up until 28 days after the final dose]
  • Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters [Time frame: From baseline up until 28 days after the final dose]

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Mayo Clinic — Phoenix
  • The University of Texas MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06287918 · 3HP-2827-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗