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
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 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
Design model
Sequential
Treatments tested in this trial
JSKN022
DrugJSKN022 administered intravenously at selected dose levels according to protocol
Treatment groups
225 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Group A: Dose escalation cohorts 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 escalation cohort 7Experimental treatment 1 intervention
Group H: Dose escalation cohort 8Experimental treatment 1 intervention
Group I: Dose optimization cohort in selected tumor type 1Experimental treatment 1 intervention
Group J: Dose optimization cohort in selected tumor type 2Experimental treatment 1 intervention
Group K: Dose optimization cohort 3 - other advanced epithelial malignant tumors cohortExperimental 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 JSKN-022).
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 assessments.
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
Incidence of dose-limiting toxicity (DLT) in each dose group
Time frame
21 days from the first dose3
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of JSKN022.
Time frame
Up to 24 monthsSecondary outcomes
1
Objective response rate (ORR)
The proportion of subjects who achieve confirmed complete response (CR) or partial response (PR) as assessed by RECIST v1.1. ORR analysis will be based on the EAS set, with the proportion of subjects achieving objective response and the Clopper-Pearson exact 95% CI calculated.
Time frame
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.2
Duration of response (DoR)
Defined as the time from the first documented evidence of response (PR or CR) to the first documented evidence of progressive disease (PD) or death from any cause in subjects with confirmed response (RECIST v1.1, PR or CR). For subjects without documented progression or death, DoR will be censored at the time of the last adequate tumor assessment. DoR analysis will be performed on subjects achieving CR or PR, with the median duration of response and 95% CI estimated using the Kaplan-Meier method.
Time frame
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed up to 24 months.3
Disease control rate (DCR)
The proportion of subjects who achieve confirmed CR, PR, or SD as assessed by RECIST v1.1. DCR analysis will be based on the EAS set, with the proportion of subjects achieving disease control and the Clopper-Pearson exact 95% CI calculated.
Time frame
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.4
Clinical benefit rate (CBR)
The proportion of subjects who achieve confirmed CR, PR, or stable disease (SD) lasting more than 6 months as assessed by RECIST v1.1. CBR analysis will be based on the EAS set, with the proportion of subjects achieving clinical benefit and the Clopper-Pearson exact 95% CI calculated.
Time frame
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.Sponsors and contacts
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Source ClinicalTrials.gov