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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors With FGFR2 Alterations, Adult
• Intervention / Treatment: Drug: 3HP-2827

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shuchao Wu; Phone Number: +86-21-50895559; Email: shuchao.wu@3hpharma.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage II - expansion; Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I.	Drug: 3HP-2827; 3HP-2827 will be administered orally once daily in 28-day cycles.
Experimental: Stage I - dose escalation; Dose escalation of 3HP-2827 in patients with advanced solid tumors.	Drug: 3HP-2827; 3HP-2827 will be administered orally once daily in 28-day cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
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 -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 ECG Parameters	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

Outcome Measure	Time Frame
Plasma Concentration of 3HP-2827 and/or its major metabolites	Initiation of study drug until study discontinuation（up to 45 months）
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
Overall survival	Up to 48 months
Dose escalation stage - Objective Response Rate (ORR)	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
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 -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters	From baseline up until 28 days after the final dose

Collaborators and Investigators

• Sponsor: 3H (Suzhou) Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 3HP-2827-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No