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

Phase 2RecruitingNCT06378593

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.

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. * Assessed by the investigator to be unsuitable for participation in this study.

Locations (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

ZhongShan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

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）

ORR refers to the percentage of patients with best overall response of confirmed CR or PR from the start of study treatment to patient withdrawal due to PD.

Time frame: Initiation of study drug until disease progression (up to approximately 36 months)

Secondary Outcomes

Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy.

Central Contacts

Shuchao Wu

CONTACT

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

Data from ClinicalTrials.gov

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Time frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))

Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy.

Time frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))

Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy.

Time frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))

Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy.

Time frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))

Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy.

Time frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))

Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy.

Time frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))

Duration of Response (DOR) as assessed by RECIST v1.1

DOR refers to the time period from the first evaluation of confirmed CR or PR (whichever occurs first) to PD or death.

Time frame: Up to 45 months

Disease control rate (DCR) as assessed by RECIST v1.1

DCR refers to the percentage of patients with best overall response of confirmed CR, PR or SD from the start of study treatment to patient withdrawal due to PD.

Time frame: Up to 45 months

Progression-free survival (PFS) as assessed by RECIST v1.1

PFS refers to the time between the date of first dose and the first PD or death due to any cause based on the investigator's imaging review results

Time frame: Up to 45 months

Overall survival (OS)

OS refers to the time from the date of first dose to the date of death due to any cause.

Time frame: Up to 48 months

Dose escalation stage - Objective Response Rate (ORR)

ORR refers to the percentage of patients with best overall response of confirmed CR or PR from the start of study treatment to patient withdrawal due to PD.

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

Expansion Stage -Changes in patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer Core QoL Questionnaire (EORTC QLQ-C30) in patients with advanced solid tumors

Time frame: From baseline up until 28 days after the final dose