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

Phase 1Not Yet RecruitingNCT06287918

3H (Suzhou) Pharmaceuticals Co., Ltd.130 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Solid Tumors With FGFR2 Alterations, Adult

Interventions

3HP-2827DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Mayo Clinic

Phoenix, Arizona, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Central Contacts

Shuchao Wu

CONTACT

+86-21-50895559 shuchao.wu@3hpharma.com

Data from ClinicalTrials.gov

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