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

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.

Study Overview

• Status: Withdrawn
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: GENA-104A16

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with histologically/cytologically confirmed unresectable, recurrent, or metastatic advanced solid tumors
• Life expectancy of at least 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
• Adequate organ function including hematological, hepatic, and renal functions.
• Negative childbearing potential
• Measurable disease as per RECIST v1.1 defined as at least 1 lesion
• Patients who are willing and able to comply with scheduled cycles, treatment plans, laboratory tests, and other procedures

Exclusion Criteria:

• A WOCBP who has a positive urine pregnancy test prior to treatment
• Received prior systemic anti-cancer therapy within 4 weeks or 5 half-life periods (whichever is shorter) prior to the first dose of treatment
• Received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
• Received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
• Currently participating and receiving study treatments or has participated in a study of an investigational agent and received the study therapy or has used an investigational device within 4 weeks prior to the first dose of study treatment
• Had an allogeneic tissue/solid organ transplant
• A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
• A known additional malignancy that is progressing or has required active treatment within the past 3 years
• A known active CNS metastases and/or carcinomatous meningitis
• A known prior severe hypersensitivity reactions to monoclonal antibodies or any component in their formulation (Grade ≥3)
• An active autoimmune disease that has required systemic treatment in past 2 years
• A history of (non infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• An active infection requiring systemic therapy, or has received a course of antibiotics within 4 weeks prior to the first dose of treatment
• A known history of human Immunodeficiency Virus (HIV) infection
• A known history of Hepatitis B or known active Hepatitis C virus (HCV) infection
• Diagnosed with Gliosis through a brain MRI and has experienced neurological conditions within 6 months before the first administration
• Has any one or more clinically significant cardiovascular disease
• A history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patients participation for the full duration of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GENA104; 80 patients in total with histologically/cytologically confirmed unresectable, recurrent, or metastatic advanced solid tumors, for who no standard therapy exists, or standard therapy has failed will be enrolled in this study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the MTD and RP2D	Incidence of dose limiting toxicity (DLT).	1 year
Incidence of Adverse Events	Assessed as per CTCAE v5.0	1 year
Incidence of Laboratory abnormalities	Assessed as per CTCAE v5.0	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax for Pharmacokinetic (PK) profile	Maximum serum concentration	1 year
Tmax for Pharmacokinetic (PK) profile	Time to reach the maximum concentration	1 year
AUC0-tlast for Pharmacokinetic (PK) profile	The area under the concentration-time curve from the time of dosing (time 0) to the time of the last observation	1 year
Half-life for Pharmacokinetic (PK) profile	Measurement of half-life as PK parameter	1 year
Clearance for Pharmacokinetic (PK) profile	Measurement of clearance as PK parameter	1 year
Potential immunogenicity	Levels of human anti-GENA-104A16 antibody	1 year
Objective response rate (ORR)	Assessed according to RECIST v1.1	1 year
Duration of response (DoR)	Assessed according to RECIST v1.1	1 year
Progression free Survival (PFS)	Assessed according to RECIST v1.1	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Biospecimens	Levels of biomarkers expression with the observed antitumor activity	1 year
Blood Biospecimens	Levels of biomarkers expression with the observed antitumor activity	1 year
Fecal Biospecimens	Levels of biomarkers expression with the observed antitumor activity	1 year

Collaborators and Investigators

• Sponsor: Genome & Company
• Investigators: Principal Investigator: Doyoun Oh, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: [GNC] GENA104-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No