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NCT Number: NCT07354711

A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors

The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3H-10000 in the treatment of unresectable or metastatic solid tumors .

Recruiting

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Key information

Conditions

Lung Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Cancer Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

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, 100142, China

Location status: Recruiting

Location contact

Lin Shen, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects must be willing and able to sign the ICF and to adhere to the study visit schedule and other protocol requirements.
  • Male or female subjects aged ≥18 years at the time of signing the ICF.
  • According to RECIST v1.1, there is at least one measurable lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 point.
  • Life expectancy of ≥3 months.

Exclusion criteria

  • Meningeal diseases or carcinomatous meningitis.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage every two weeks or more frequently.
  • Having received treatment with other investigational drugs within 4 weeks prior to the first dose of the study drug.
  • Any AEs induced by prior anti-tumor therapy having not resolved to Grade 1 or lower (except for alopecia or any other Grade 2 AEs assessed by the investigator as not being associated with any safety risk).
  • Any corneal or retinal disease/keratopathy assessed by the investigator as of clinical significance, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis.

Treatment and study plan

3H-10000

Drug

3H-10000 will be administered by infusion Q2W in 28-day cycles.

Primary outcomes

  1. Dose Escalation Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to approximately 2 years

    Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0)), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria and AEs meeting protocol-defined adverse event of clinical interest (AECIs)

  2. Dose Escalation Phase：Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of 3H-10000

    Time frame: Up to approximately 2 years

    The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate, or the highest dose administered, respectively.

  3. Dose Escalation Phase：The recommended Phase 2 dose (RP2D) of 3H-10000

    Time frame: Up to approximately 2 years

    The RP2D of 3H-10000 monotherapy will be determined based on relevant data, as available

  4. Efficacy Expansion Phase：Overall Response Rate (ORR)

    Time frame: Up to approximately 2 years

    ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Secondary outcomes

  1. Dose Escalation Phase：ORR

    Time frame: Up to approximately 2 years

    ORR is defined as the percentage of participants with CR or PR, as determined by RECIST v1.1

  2. Dose Escalation Phase and Efficacy Expansion Phase：Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years

    DCR is defined as the percentage of participants with best overall response of a CR, PR, and stable disease, as assessed by RECIST v1.1

  3. Dose Escalation Phase and Efficacy Expansion Phase：Duration of Response (DOR)

    Time frame: Up to approximately 2 years

    DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever comes first, as assessed using RECIST v1.1

  4. Efficacy Expansion Phase：Progression Free Survival (PFS)

    Time frame: Up to approximately 2 years

    PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed using RECIST v1.1 or death, whichever occurs first

  5. Efficacy Expansion Phase：Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to approximately 2 years

    Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0), and AEs meeting protocol-defined adverse event of clinical interest (AECI)s.

  6. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Twice in the first 3 months

    AUC0-last

  7. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Twice in the first 3 months

    AUC0-inf

  8. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Twice in the first 3 months

    Cmax

  9. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Twice in the first 3 months

    Tmax

  10. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Twice in the first 3 months

    Ctrough

  11. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Twice in the first 3 months

    CL

  12. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Twice in the first 3 months

    t1/2

  13. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Twice in the first 3 months

    Vd

  14. Dose Escalation Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Twice in the first 3 months

    Vss

  15. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Up to approximately 2 years

    AUC0-last

  16. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Up to approximately 2 years

    AUC0-inf

  17. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Up to approximately 2 years

    Cmax

  18. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Up to approximately 2 years

    Tmax

  19. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Up to approximately 2 years

    Ctrough

  20. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Up to approximately 2 years

    CL

  21. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Up to approximately 2 years

    t1/2

  22. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Up to approximately 2 years

    Vd

  23. Efficacy Expansion Phase：To evaluate the pharmacokinetics (PK) of 3H-10000

    Time frame: Up to approximately 2 years

    Vss

Study contacts

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

Shuchao Wu

CONTACT

[email protected]

0086-21-50895559

Sponsors and collaborators

Lead sponsor

3H Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase I/II Study of 3H-10000 (an Anti-FGFR2b Antibody-Drug Conjugate) in Subjects With Unresectable or Metastatic Advanced Solid Tumors

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 21, 2026
Registry last updated
Jan 21, 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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