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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 .

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

3H-10000

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

Locations (1)

Beijing Cancer Hospital
Beijing, Beijing Municipality, China