JSKN022 in Subjects With Advanced Malignant Solid Tumors

NCT07292402 | Recruiting Phase 1

• 1 other identifier: JSKN022-101
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignant Solid Tumors

Keywords

JSKN022; PD-L1; ITGB6; Antibody-Drug Conjugates

Outcome Measures

Primary Outcomes (3)

• 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.

  From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.

• Incidence of dose-limiting toxicity (DLT) in each dose group

  21 days from the first dose

• Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of JSKN022.

  Up to 24 months

Secondary Outcomes (14)

• Objective response rate (ORR)

  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.

• Duration of response (DoR)

  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.

• Disease control rate (DCR)

  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.

• Clinical benefit rate (CBR)

  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.

• Progression-Free Survival (PFS)

  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.

Study Arms (11)

Dose escalation cohorts 1

EXPERIMENTAL

Drug: JSKN022

Dose escalation cohort 2

EXPERIMENTAL

Drug: JSKN022

Dose escalation cohort 3

EXPERIMENTAL

Drug: JSKN022

Dose escalation cohort 4

EXPERIMENTAL

Drug: JSKN022

Dose escalation cohort 5

EXPERIMENTAL

Drug: JSKN022

Dose escalation cohort 6

EXPERIMENTAL

Drug: JSKN022

Dose escalation cohort 7

EXPERIMENTAL

Drug: JSKN022

Dose escalation cohort 8

EXPERIMENTAL

Drug: JSKN022

Dose optimization cohort in selected tumor type 1

EXPERIMENTAL

Drug: JSKN022

Dose optimization cohort in selected tumor type 2

EXPERIMENTAL

Drug: JSKN022

Dose optimization cohort 3 - other advanced epithelial malignant tumors cohort

EXPERIMENTAL

Drug: JSKN022

Interventions

JSKN022 DRUG

JSKN022 administered intravenously at selected dose levels according to protocol

Dose escalation cohort 2; Dose escalation cohort 3; Dose escalation cohort 4; Dose escalation cohort 5; Dose escalation cohort 6; Dose escalation cohort 7; Dose escalation cohort 8; Dose escalation cohorts 1; Dose optimization cohort 3 - other advanced epithelial malignant tumors cohort; Dose optimization cohort in selected tumor type 1; Dose optimization cohort in selected tumor type 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• At least one measurable lesion at baseline according to RECIST 1.1 criteria.
• Adequate organ function.
• Agree to provide Recently archived or fresh tumor tissue samples.
• Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
• Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
• Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
• Adequate washout period of previous therapy before the first dose.

You may not qualify if:

• 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.
• Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
• Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• Gastrointestinal abnormalities with obvious clinical manifestations.
• Active autoimmune diseases requiring systemic treatment within the past two years.
• Significant serous effusion.
• Uncontrolled infection.
• Require regular glucocorticoid or immunosuppressive therapy.
• Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
• Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors.
• Previous occurrence of grade ≥ 3 immune-related adverse events during immunotherapy.
• Toxicity of previous anti-tumor treatment has not fully or partially recovered.

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Central Study Contacts

Ruihua Xu, Dr.

CONTACT

086-020-87343468; ruihxu@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 18, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)