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JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors

NCT06226766 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-09-10

No results posted yet for this study

Summary

This study is an open-label, multicenter, first-in-human, Phase I/II (dose escalation and dose expansion) study to evaluate the safety, tolerability, PK, immunogenicity and efficacy of JSKN033 in patients with advanced unresectable or metastatic solid malignant tumors that are expected to be HER2 expression (IHC ≥ 1+).

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

JSKN033 Injection

JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection.

Sponsors & Collaborators

  • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Charlotte Lemech · Scientia Clinical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06226766 on ClinicalTrials.gov