JSKN033 in Chinese Subjects with Advanced Malignant Tumors

NCT06770881 | Not Yet Recruiting Phase 1

• 1 other identifier: JSKN033-102
• Study Type: interventional
• Target: 430
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity (DLT)

  Incidence of DLT in the dose escalation period.

  Up to 12 months

• Maximum Tolerated Dose (MTD) or recommend Phase II dose (RP2D).

  Based on safety and efficacy data.

  Up to 12 months

• Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAE) and Treatment Related Adverse Events (TRAE)

  TEAE and TRAE were graded according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

  Throughout the duration of the study, approximately 2 years

Secondary Outcomes (7)

• Anti-drug antibodies (ADA) and neutralizing antibodies

  Throughout the duration of the study, about 2 years

• Objective response rate (ORR)

  Throughout the duration of the study, about 2 years

• Disease control rate (DCR)

  Throughout the duration of the study, about 2 years

• Progression-free survival (PFS)

  Throughout the duration of the study, about 2 years

• Maximum concentration (Cmax)

  Throughout the duration of the study, about 2 years

Study Arms (1)

JSKN033

EXPERIMENTAL

Drug: JSKN033

Interventions

JSKN033 DRUG

JSKN033 should be administered subcutaneously on the first day of each week cycle/ each 2-week cycle

JSKN033

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Has clinically active brain metastases.
• Previously received any other investigational drug within 28 days prior to enrollment.
• Previously received local palliative treatment within 14 days prior to enrollment.
• Previously received major surgeries within 28 days prior to enrollment.
• Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.
• Previously received live vaccine within 28 days prior to enrollment.
• Previously received antibody conjugate drug with topoisomerase I inhibitor.
• Has a history of other primary malignant tumors within 5 years prior to enrollment.
• Has uncontrolled comorbidities as specified by the protocol.
• 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.
• 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.
• Toxicities of previous antitumor therapy did not resolve to grade 1 defined by CTCAE v5.0.
• Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug.
• Has a history of allogeneic bone marrow or organ transplantation.
• Pregnant or breastfeeding female patients.

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Officials

• XiaoHua Wu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XiaoHua Wu, MD

CONTACT

02134778299; wu.xh@fudan.edu.cn

Jian Zhang, MD

CONTACT

02134778299; syner2000@163.com

Study Design

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

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 13, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share