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

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 .

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.