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

NCT06235541 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Genome & Company

    lead INDUSTRY

Principal Investigators

  • Doyoun Oh · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2026-09-30
Completion
2027-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

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 NCT06235541 on ClinicalTrials.gov