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
- Phase
- Phase 1
- Intervention
- 3HP-2827
- Conditions
- Solid Tumors With FGFR2 Alterations, Adult
- Sponsor
- 3H (Suzhou) Pharmaceuticals Co., Ltd.
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Dose Escalation Stage- incidence of adverse events (AEs)
- Status
- Not yet recruiting
- Last Updated
- 3 months ago
Overview
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. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).
Investigators
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
- •An expected survival of ≥ 12 weeks.
- •Evaluable or measurable disease per RECIST v1.
- •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
- •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.
Arms & Interventions
Stage I - dose escalation
Dose escalation of 3HP-2827 in patients with advanced solid tumors.
Intervention: 3HP-2827
Stage II - expansion
Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I.
Intervention: 3HP-2827
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 -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 -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- 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 Clinical Laboratory Test Results
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(Initiation of study drug until study discontinuation（up to 45 months）)
- 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)
- Duration of Response (DOR) as assessed by RECIST v1.1(Up to 45 months)
- Progression-free survival (PFS) as assessed by RECIST v1.1(Up to 45 months)
- 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)
- 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)
- Overall survival(Up to 48 months)