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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
JSKN027
DrugJSKN027 is an investigational therapeutic agent being evaluated for the treatment of advanced malignant solid tumors. It is administered as intravenous monotherapy at multiple dose levels in this study.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: JSKN027Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Dose-Limiting Toxicities (DLTs)
The number of participants who experience dose-limiting toxicities (DLTs) during the dose-limiting toxicity evaluation period following administration of JSKN027
Time frame
From first dose of JSKN027 through 21 days after the first dose (DLT evaluation period)2
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
The number of participants who experience treatment-emergent adverse events (TEAEs) following administration of JSKN027, graded according to NCI CTCAE version 5.0.
Time frame
From first dose of JSKN027 through 30 days after the last dose3
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of JSKN027
Determination of the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of JSKN027 based on observed dose-limiting toxicities and overall safety and tolerability.
Time frame
From first dose of JSKN027 through completion of dose-escalation phase (approximately 12 months)Secondary outcomes
1
Objective Response Rate (ORR) as Assessed by RECIST v1.1
Objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST version 1.1.
Time frame
From first dose of JSKN027 until disease progression or death, up to 24 months2
Disease Control Rate (DCR) as Assessed by RECIST v1.1
Disease control rate (DCR), defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to RECIST version 1.1.
Time frame
From first dose of JSKN027 until disease progression or death, up to 24 months3
Duration of Response (DoR) as Assessed by RECIST v1.1
Duration of response (DoR), defined as the time from first documented objective response (CR or PR) to disease progression or death, as assessed according to RECIST version 1.1.
Time frame
From first documented response until disease progression or death, up to 24 months4
Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from first dose of JSKN027 to the first documentation of disease progression or death from any cause.
Time frame
From first dose of JSKN027 until disease progression or death, up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov
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