Pure Global

A First-in-human Study of GENA-104A16 in Patients With Advanced Solid Tumors - Trial NCT06235541

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT06235541
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06235541
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Advanced Solid Tumors

GENA-104A16

Interventional

drug

Sponsor & Location

Genome & Company

Seoul, South Korea

Timeline & Enrollment

Phase 1

Feb 01, 2024

May 01, 2027

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: Prepuce
Carcinoma in situ, unspecified
Malignant neoplasm: Connective and soft tissue, unspecified
Malignant neoplasm: Parametrium
Malignant neoplasm: Orbit

Data Source

ClinicalTrials.gov

NCT06235541

Non-Device Trial