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

January 26, 2026 updated by: 3H (Suzhou) Pharmaceuticals Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Lin Shen, MD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200123
        • Recruiting
        • Zhongshan Hospital
        • Contact:
          • Jia Fan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Measure Description
Time Frame
Dose Escalation Stage- incidence of adverse events (AEs)
Time Frame: From baseline up until 28 days after the final dose
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)
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
Time Frame: From baseline up until 28 days after the final dose
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
Time Frame: From baseline up until 28 days after the final dose
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
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)
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)
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.
Initiation of study drug until disease progression (up to approximately 36 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expansion Stage- incidence of adverse events (AEs)
Time Frame: From baseline up until 28 days after the final dose
From baseline up until 28 days after the final dose
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs
Time Frame: From baseline up until 28 days after the final dose
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
Time Frame: From baseline up until 28 days after the final dose
From baseline up until 28 days after the final dose
Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters
Time Frame: From baseline up until 28 days after the final dose
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.
Time Frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
Initiation of study drug until study discontinuation, (up to approximately 24 months))
Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy.
Time Frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
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.
Time Frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
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.
Time Frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
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.
Time Frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
Initiation of study drug until study discontinuation, (up to approximately 24 months))
Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy.
Time Frame: Initiation of study drug until study discontinuation, (up to approximately 24 months))
Initiation of study drug until study discontinuation, (up to approximately 24 months))
Duration of Response (DOR) as assessed by RECIST v1.1
Time Frame: 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.
Up to 45 months
Disease control rate (DCR) as assessed by RECIST v1.1
Time Frame: 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.
Up to 45 months
Progression-free survival (PFS) as assessed by RECIST v1.1
Time Frame: 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
Up to 45 months
Overall survival (OS)
Time Frame: Up to 48 months
OS refers to the time from the date of first dose to the date of death due to any cause.
Up to 48 months
Dose escalation stage - Objective Response Rate (ORR)
Time Frame: 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.
Up to 45 months
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
Time Frame: From baseline up until 28 days after the final dose
From baseline up until 28 days after the final dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3H (Suzhou) Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

June 16, 2028

Study Completion (Estimated)

June 16, 2028

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 22, 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-2827-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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