A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors
Recruiting · NCT07354711 · Interventional (participants receive a specific treatment) · Lead sponsor: 3H Pharmaceuticals Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
3H-10000
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China