A Phase I Study of JSKN021 in Advanced Solid Tumors
ConditionAdvanced Malignant Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd
About this trial
This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.
Eligibility criteria
Qualifiers
Voluntarily participate and sign the informed consent form.
Age ≥ 18 and ≤ 75 years old, male or female.
Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
Expected survival ≥ 3 months.
Disqualifiers
Complicated with other malignant tumors within 3 years before the first dose.
History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
Trial design
Treatments tested in this trial
- JSKN021
Treatment groups
199 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov