A First-in-human Study of 3H-10000 in Patients With Unresectable or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor3H Pharmaceuticals Co., Ltd.
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 .
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- 3H-10000
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov