JSKN033 in Chinese Subjects with Advanced Malignant Tumors

Phase 1

Not yet recruiting

• Conditions: Advanced Malignant Tumors
• Interventions: Drug: JSKN033

• Registration Number: NCT06770881
• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Brief Summary

This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-01-15
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

1. Be able to understand informed consent form, voluntarily participate and sign informed consent form.
2. Age ≥18 year (at the time consent is obtained), male or female.
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Has a Life expectancy ≥3 months.
5. Has a pathologically documented advanced/unresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.
6. Has at least 1 measurable lesion at baseline according to RECIST 1.1 criteria.
7. Must have adequate organ function prior to the start of JSKN033.
8. Negative urine/serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.

Exclusion Criteria

1. Has clinically active brain metastases.
2. Previously received any other investigational drug within 28 days prior to enrollment.
3. Previously received local palliative treatment within 14 days prior to enrollment.
4. Previously received major surgeries within 28 days prior to enrollment.
5. Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.
6. Previously received live vaccine within 28 days prior to enrollment.
7. Previously received antibody conjugate drug with topoisomerase I inhibitor.
8. Has a history of other primary malignant tumors within 5 years prior to enrollment.
9. Has uncontrolled comorbidities as specified by the protocol.
10. Has a history of interstitial pneumonia/lung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia/lung disease that cannot be ruled out by imaging during screening period.
11. Subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc.
12. Toxicities of previous antitumor therapy did not resolve to grade 1 defined by CTCAE v5.0.
13. Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug.
14. Has a history of allogeneic bone marrow or organ transplantation.
15. Pregnant or breastfeeding female patients.
16. Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JSKN033	JSKN033	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Up to 12 months	Incidence of DLT in the dose escalation period.
Maximum Tolerated Dose (MTD) or recommend Phase II dose (RP2D).	Up to 12 months	Based on safety and efficacy data.
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAE) and Treatment Related Adverse Events (TRAE)	Throughout the duration of the study, approximately 2 years	TEAE and TRAE were graded according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

Secondary Outcome Measures

Name	Time	Method
Anti-drug antibodies (ADA) and neutralizing antibodies	Throughout the duration of the study, about 2 years	Status (positive or negative) and serum titers of anti-JSKN033 antibody.
Objective response rate (ORR)	Throughout the duration of the study, about 2 years	ORR is determined by investigators based on RECIST 1.1 criteria.
Disease control rate (DCR)	Throughout the duration of the study, about 2 years	DCR is determined by investigators based on RECIST 1.1 criteria.
Progression-free survival (PFS)	Throughout the duration of the study, about 2 years	PFS is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic disease progression or death due to any cause.
Maximum concentration (Cmax)	Throughout the duration of the study, about 2 years	Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab.
Time at which Cmax is reached (Tmax)	Throughout the duration of the study, about 2 years	Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab.
Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)	Throughout the duration of the study, about 2 years	Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab.