Clinical trial NCT06378593: A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
Official title: An Open-Label, Multi-center Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumors With FGFR2 Alterations, Adult
Lead sponsor: 3H (Suzhou) Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Dose Escalation Stage- incidence of adverse events (AEs)
timeFrame: From baseline up until 28 days after the final dose
measure: Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs)
timeFrame: Days 1-28 of Cycle 1 (a cycle is 28 days)
measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs
timeFrame: From baseline up until 28 days after the final dose
measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results
timeFrame: From baseline up until 28 days after the final dose
measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters
timeFrame: From baseline up until 28 days after the final dose
measure: 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
timeFrame: Initiation of study drug until study discontinuation, (up to approximately 24 months)
measure: Expansion stage -Objective response rate（ORR）
timeFrame: Initiation of study drug until disease progression (up to approximately 36 months)
Secondary outcomes:
measure: Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy.
timeFrame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
measure: Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy.
timeFrame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
measure: Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy.
timeFrame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
measure: Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy.
timeFrame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
measure: Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy.
timeFrame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
measure: Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy.
timeFrame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
measure: Duration of Response (DOR) as assessed by RECIST v1.1
timeFrame: Up to 45 months
measure: Disease control rate (DCR) as assessed by RECIST v1.1
timeFrame: Up to 45 months
measure: Progression-free survival (PFS) as assessed by RECIST v1.1
timeFrame: Up to 45 months
measure: Overall survival (OS)
timeFrame: Up to 48 months
measure: Dose escalation stage - Objective Response Rate (ORR)
timeFrame: Up to 45 months
measure: Expansion Stage- incidence of adverse events (AEs)
timeFrame: From baseline up until 28 days after the final dose
measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs
timeFrame: From baseline up until 28 days after the final dose
measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results
timeFrame: From baseline up until 28 days after the final dose
measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters
timeFrame: From baseline up until 28 days after the final dose
measure: 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
timeFrame: From baseline up until 28 days after the final dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Shanghai
country: China
facility: ZhongShan Hospital
state: Shanghai
Study officials:
References: