A Phase I Study of JSKN021 in Advanced Solid Tumors
ConditionAdvanced Malignant Solid Tumors
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 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
Design model
Sequential
Treatments tested in this trial
JSKN021
DrugJSKN021 administered intravenously at selected dose levels according to protocol
Treatment groups
199 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Dose escalation cohort 1Experimental treatment 1 intervention
Group B: Dose escalation cohort 2Experimental treatment 1 intervention
Group C: Dose escalation cohort 3Experimental treatment 1 intervention
Group D: Dose escalation cohort 4Experimental treatment 1 intervention
Group E: Dose escalation cohort 5Experimental treatment 1 intervention
Group F: Dose escalation cohort 6Experimental treatment 1 intervention
Group G: Dose optimization cohort 1Experimental treatment 1 intervention
Group H: Dose optimization cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021)
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc.; abnormalities in physical examinations, laboratory tests, electrocardiograms, and other safety measures.
Time frame
From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.2
Dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) in each dose group.
Time frame
21 days from the first dose3
Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.
Based on safety and efficacy data.
Time frame
Up to 24 monthsSecondary outcomes
1
Objective response rate (ORR)
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1）
Time frame
Up to 24months2
Duration of response (DoR)
Duration of response (DoR) assessed according to RECIST v1.1.
Time frame
Up to 24months3
Disease control rate (DCR)
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame
Up to 24months4
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression or death due to any cause (whichever occurs first).
Time frame
Up to 24monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov