A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
- Registration Number
- NCT06378593
- Lead Sponsor
- 3H (Suzhou) Pharmaceuticals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Stage I - dose escalation 3HP-2827 Dose escalation of 3HP-2827 in patients with advanced solid tumors. Stage II - expansion 3HP-2827 Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I.
- Primary Outcome Measures
Name Time Method 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 Initiation of study drug until study discontinuation, (up to approximately 24 months) 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) Expansion stage -Objective response rate（ORR） Initiation of study drug until disease progression (up to approximately 36 months) 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.
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters 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 From baseline up until 28 days after the final dose Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs From baseline up until 28 days after the final dose
- Secondary Outcome Measures
Name Time Method Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy. Initiation of study drug until study discontinuation, (up to approximately 24 months)) Disease control rate (DCR) as assessed by RECIST v1.1 Up to 45 months 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.
Progression-free survival (PFS) as assessed by RECIST v1.1 Up to 45 months 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
Expansion Stage- incidence of adverse events (AEs) From baseline up until 28 days after the final dose Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs From baseline up until 28 days after the final dose Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy. Initiation of study drug until study discontinuation, (up to approximately 24 months)) Duration of Response (DOR) as assessed by RECIST v1.1 Up to 45 months DOR refers to the time period from the first evaluation of confirmed CR or PR (whichever occurs first) to PD or death.
Overall survival (OS) Up to 48 months OS refers to the time from the date of first dose to the date of death due to any cause.
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters From baseline up until 28 days after the final dose Dose escalation stage - Objective Response Rate (ORR) Up to 45 months 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.
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results 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 From baseline up until 28 days after the final dose Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy. 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. 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. 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. Initiation of study drug until study discontinuation, (up to approximately 24 months))
Trial Locations
- Locations (2)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
ZhongShan Hospital
🇨🇳Shanghai, Shanghai, China