RecruitingPhase 1Phase 2NCT07354711

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

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

Sponsor

3H Pharmaceuticals Co., Ltd.

Enrollment

170 participants

Start Date

Jan 4, 2026

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Stomach Cancer

Summary

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 .

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria5

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.