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

Phase 1

Not yet recruiting

• Conditions: Solid Tumors With FGFR2 Alterations, Adult
• Interventions: Drug: 3HP-2827

• Registration Number: NCT06287918
• 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. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-01
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Study Start: 2025-06
• Primary Completion: 2028-03
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_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.
• 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.

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- incidence of adverse events (AEs)	From baseline up until 28 days after the final dose
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 Vital Signs	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)
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 -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)
Expansion stage -Objective response rate（ORR）	Initiation of study drug until disease progression (up to approximately 36 months)

Secondary Outcome Measures

Name	Time	Method
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
Overall survival	Up to 48 months
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

Trial Locations

Locations (2)

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States