A Phase I Study of JSKN021 in Advanced Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Malignant Solid Tumors
• Intervention / Treatment: Drug: JSKN021

• Study Type: Interventional
• Enrollment (Estimated): 199
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jian Zhang, MD; Phone Number: 08602134778299; Email: syner2000@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Voluntarily participate and sign the informed consent form.
2. Age ≥ 18 and ≤ 75 years old, male or female.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
4. Expected survival ≥ 3 months.
5. Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
6. At least one measurable lesion at baseline according to RECIST 1.1 criteria.
7. Adequate organ function.
8. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
9. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
10. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
11. Adequate washout period of previous therapy before the first dose.

Exclusion Criteria:

1. Complicated with other malignant tumors within 3 years before the first dose.
2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
4. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
5. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
6. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
7. Uncontrolled infection.
8. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
9. Toxicity of previous anti-tumor treatment has not fully or partially recovered.
10. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
11. Pregnant and/or lactating women, or planning to become pregnant during the study period.
12. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation cohort 2	Drug: JSKN021; JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 3	Drug: JSKN021; JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 4	Drug: JSKN021; JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 5	Drug: JSKN021; JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 6	Drug: JSKN021; JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose escalation cohort 1	Drug: JSKN021; JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose optimization cohort 1	Drug: JSKN021; JSKN021 administered intravenously at selected dose levels according to protocol
Experimental: Dose optimization cohort 2	Drug: JSKN021; JSKN021 administered intravenously at selected dose levels according to protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
Dose-limiting toxicity (DLT)	Incidence of dose-limiting toxicity (DLT) in each dose group.	21 days from the first dose
Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.	Based on safety and efficacy data.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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）	Up to 24months
Duration of response (DoR)	Duration of response (DoR) assessed according to RECIST v1.1.	Up to 24months
Disease control rate (DCR)	Disease control rate (DCR) assessed according to RECIST v1.1.	Up to 24months
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).	Up to 24months
Overall survival(OS)	Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.	Up to 24months
Immunogenicity	Incidence and titer changes of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs, if applicable)	Up to 24months
Maximum concentration (Cmax) of JSKN021	Maximum concentration (Cmax) of JSKN021	Up to 24months
Time to maximum concentration (Tmax) of JSKN021	Time to maximum concentration (Tmax) of JSKN021	Up to 24 months.
Trough concentration (Ctrough) of JSKN021	Trough concentration (Ctrough) of JSKN021	Up to 24 months
Area under the concentration-time curve of JSKN021	Area under the concentration-time curve of JSKN021	Up to 24 months
Volume of distribution (V) of JSKN021	Volume of distribution (V) of JSKN021	Up to 24 months
Elimination half-life (t1/2) of JSKN021	Elimination half-life (t1/2) of JSKN021	Up to 24 months
Clearance (CL) of JSKN021	Clearance (CL) of JSKN021	Up to 24 months

Collaborators and Investigators

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: EGFR/HER3; JSKN021
• Other Study ID Numbers: JSKN021-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared. The informed consent form does not include provisions for sharing de-identified participant-level data with researchers outside the study team.

Drug and device information, study documents

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