NCT06235541

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Genome & Company · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GENA-104A16	GENA-104A16 is administered as a 1 hour (h) \[-5 minutes and +60 minutes , i.e., 55-120 minutes as window time\] as intravenous (IV) infusion on q2w.

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-09-01
• Completion: 2027-05-01
• First posted: 2024-02-01
• Last updated: 2025-07-17

Locations

1 site across 1 country: South Korea