JSKN022 in Subjects With Advanced Malignant Solid Tumors
ConditionAdvanced Malignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd
About this trial
The goal of this clinical trial is to learn if drug JSKN022 is safe to treat patients with advanced malignant solid tumors. It will also learn about the pharmacokinetic/ pharmacodynamic profiles and preliminary antitumor activity of drug JSKN022.
Eligibility criteria
Qualifiers
Voluntarily participate and sign the informed consent form.
Age ≥ 18 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 5 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk or tumor types with disease-free survival ≥ 5 years after radical treatment and extremely low recurrence/metastasis risk.
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, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration.
Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
Trial design
Treatments tested in this trial
- JSKN022
Treatment groups
225 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov