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

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

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.

Conditions3

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