A Study of JSKN027 in Patients With Advanced Solid Tumors

A First-in-Human, Open-Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of JSKN027 in Patients With Advanced Malignant Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Malignant Solid Tumor
• Intervention / Treatment: Drug: JSKN027

Detailed Description

This is a first-in-human, open-label, multicenter Phase 1 (Ia/Ib) clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of JSKN027 in patients with advanced malignant solid tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).

The study consists of two parts: a dose-escalation phase (Part Ia) and a dose-expansion phase (Part Ib). In Part Ia, an accelerated titration design followed by an i3+3 dose-escalation design will be used to evaluate multiple dose levels of JSKN027 and assess its safety and tolerability. In Part Ib, multiple expansion cohorts will be enrolled based on tumor type to further evaluate the safety and preliminary efficacy of JSKN027 at selected dose levels. Initial expansion cohorts are planned for patients with colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and hepatocellular carcinoma (HCC).

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trial Enrollment Contact; Phone Number: +86-1 5 2 0 1 3 9 3 1 2 0; Email: ruiliu@alphamabonc.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Peking University Cancer Hospital
      • Contact: Lin Shen, MD; Phone Number: +86-10-88121122; Email: shenlin@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• For dose escalation (Part Ia): disease has progressed on standard therapy.
• For dose expansion (Part Ib): participants with prespecified tumor types (e.g., colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and other selected solid tumors) who have progressed on standard therapy.
• At least one measurable extracranial lesion per RECIST v1.1.
• Adequate bone marrow function within 7 days prior to enrollment (e.g., ANC ≥ 1.5×10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100×10^9/L).
• Adequate hepatic function within 7 days prior to enrollment (e.g., total bilirubin, AST/ALT, ALP within protocol-defined limits; albumin ≥ 30 g/L).
• Adequate renal function within 7 days prior to enrollment (e.g., serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min; urine protein within acceptable limits).
• Adequate coagulation function within 7 days prior to enrollment (e.g., PT/INR and aPTT within protocol-defined limits).
• Adequate cardiac function (e.g., LVEF ≥ 50%).
• Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
• Participants of reproductive potential agree to use highly effective contraception from ICF signing until 7 months after the last dose.

Exclusion Criteria:

• 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.
• Significant gastrointestinal disorders that increase risk of perforation, bleeding, obstruction, or interfere with study participation.
• Active or uncontrolled interstitial lung disease (ILD) or non-infectious pneumonitis, or suspected ILD/pneumonitis at screening.
• Active autoimmune disease requiring systemic immunosuppression (exceptions may apply for limited, stable conditions).
• Active hepatitis B or C, HIV infection, or other clinically significant immunodeficiency/infection not adequately controlled per local standards.
• Prior allogeneic organ or bone marrow transplant.
• Known hypersensitivity to the study drug or its excipients, or history of severe hypersensitivity to similar biologic agents.
• Pregnant or breastfeeding.
• Any condition that, in the investigator's judgment, would compromise participant safety or compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JSKN027; Participants will receive JSKN027 administered by intravenous infusion at dose levels based on actual body weight (mg/kg). The planned dose levels are 1, 3, 6, 10, 15, and 20 mg/kg, administered once every 3 weeks (Q3W).	Drug: JSKN027; JSKN027 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From first dose of JSKN027 through 21 days after the first dose (DLT evaluation period)
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.	From first dose of JSKN027 through 30 days after the last dose
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.	From first dose of JSKN027 through completion of dose-escalation phase (approximately 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From first dose of JSKN027 until disease progression or death, up to 24 months
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.	From first dose of JSKN027 until disease progression or death, up to 24 months
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.	From first documented response until disease progression or death, up to 24 months
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.	From first dose of JSKN027 until disease progression or death, up to 24 months
Overall Survival (OS)	Overall survival (OS), defined as the time from first dose of JSKN027 to death from any cause.	From first dose of JSKN027 until death from any cause, up to 36 months

Collaborators and Investigators

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: JSKN027-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No