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First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors

NCT05494918 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-08-22

No results posted yet for this study

Summary

This study is an open-label, multicenter, first-in-human, Phase I, dose escalation study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of JSKN003 in subjects with advanced inoperable or metastatic solid malignant tumors that are expected to be HER2 expression.

Conditions

Interventions

DRUG

JSKN003

JSKN003 is to be administered via intravenous (IV) dose

Sponsors & Collaborators

  • Alphamab (Australia) Co Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Arlene Chan · Breast Cancer Research Centre-WA,Hollywood Consulting Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2025-04-15
Completion
2025-04-15

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

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 NCT05494918 on ClinicalTrials.gov