A Study of JSKN027 in Patients With Advanced Solid Tumors
ConditionAdvanced Malignant Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd
About this trial
This is a first-in-human, open-label, multicenter Phase 1 (Ia/Ib) clinical study conducted in China to evaluate the safety and tolerability of JSKN027 in patients with advanced malignant solid tumors. The study will also assess the pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of JSKN027, and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).
The study includes two parts. Part Ia is a dose-escalation phase designed to evaluate the safety and tolerability of increasing dose levels of JSKN027. Part Ib is a dose-expansion phase in which additional patients will be enrolled at selected dose levels to further evaluate safety and preliminary antitumor activity in specific tumor types. Initial expansion cohorts are planned for patients with colorectal cancer, non-small cell lung cancer, and hepatocellular carcinoma.
Eligibility criteria
Qualifiers
Age ≥ 18 years at the time of signing the ICF.
ECOG performance status 0-1.
Estimated life expectancy ≥ 3 months.
Histologically or cytologically confirmed advanced or metastatic malignant solid tumor.
Disqualifiers
Active central nervous system (CNS) disease (e.g., active brain metastases or leptomeningeal disease).
Received an investigational agent within 28 days or 5 half-lives (whichever is shorter) prior to first dose.
Major surgery within 28 days prior to first dose or planned major surgery during the study.
History of severe immune-related adverse events or prior toxicity that would preclude safe participation, as judged by the investigator.
Trial design
Treatments tested in this trial
- JSKN027
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov