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NCT Number: NCT06378593

A Study of 3HP-2827 in Treatment of 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.

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Key information

Conditions

Solid Tumors With FGFR2 Alterations, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3HP-2827

Drug

3HP-2827 will be administered orally once daily in 28-day cycles.

Primary outcomes

  1. Dose Escalation Stage- incidence of adverse events (AEs)

    Time frame: From baseline up until 28 days after the final dose

  2. Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs)

    Time frame: Days 1-28 of Cycle 1 (a cycle is 28 days)

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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.

Secondary outcomes

  1. 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))

  2. 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))

  3. 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))

  4. 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))

  5. 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))

  6. 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))

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. Expansion Stage- incidence of adverse events (AEs)

    Time frame: From baseline up until 28 days after the final dose

  13. 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

  14. 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

  15. 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

  16. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shuchao Wu

CONTACT

[email protected]

+86-21-50895559

Sponsors and collaborators

Lead sponsor

3H (Suzhou) Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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