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NCT06235541Not yet recruiting

A First-in-human Study of GENA-104A16 in Patients With Advanced Solid Tumors

A Phase I Study to Evaluate the Safety and Tolerability of GENA-104A16 (Anti-contactin4 [CNTN4] Monoclonal Antibody [mAb]) in Patients With Advanced Solid Tumors
Genome & CompanyPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Advanced Solid Tumors
Drug/Device/Intervention
GENA-104A16
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Genome & Company
Location
Seoul, South Korea
Timeline & enrollment
Phase
Phase 1
Start date
Feb 01, 2024
End date
May 01, 2027
Enrollment
80 participants
Primary outcome

To determine the MTD and RP2D,Incidence of Adverse Events,Incidence of Laboratory abnormalities

Summary

This is a first in human phase I , open label study to evaluate the safety and tolerability
 of GENA 104A16 administered as a single agent by intravenous (IV) once every 2 weeks ( q2w (1
 cycle = 2 weeks) in patients with advanced solid tumors, for who no standard therapy exists,
 or standard therapy has failed.

ICD-10 classifications
Malignant neoplasm: PrepuceCarcinoma in situ, unspecifiedMalignant neoplasm: Connective and soft tissue, unspecifiedMalignant neoplasm: ParametriumMalignant neoplasm: Orbit
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06235541
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06235541 through Pure Global AI's free database. This Phase 1 trial is sponsored by Genome & Company and is currently Not yet recruiting. The study focuses on Advanced Solid Tumors. Target enrollment is 80 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.