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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06235541
Other study ID # [GNC] GENA104-101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date February 2024
Est. completion date May 2027

Study information

Verified date January 2024
Source Genome & Company
Contact Clinical Group
Phone +8248212451
Email GNC_Clinical@genomecom.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date May 2027
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu

Sponsors (1)

Lead Sponsor Collaborator
Genome & Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Tumor Biospecimens Levels of biomarkers expression with the observed antitumor activity 1 year
Other Blood Biospecimens Levels of biomarkers expression with the observed antitumor activity 1 year
Other Fecal Biospecimens Levels of biomarkers expression with the observed antitumor activity 1 year
Primary To determine the MTD and RP2D Incidence of dose limiting toxicity (DLT). 1 year
Primary Incidence of Adverse Events Assessed as per CTCAE v5.0 1 year
Primary Incidence of Laboratory abnormalities Assessed as per CTCAE v5.0 1 year
Secondary Cmax for Pharmacokinetic (PK) profile Maximum serum concentration 1 year
Secondary Tmax for Pharmacokinetic (PK) profile Time to reach the maximum concentration 1 year
Secondary 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
Secondary Half-life for Pharmacokinetic (PK) profile Measurement of half-life as PK parameter 1 year
Secondary Clearance for Pharmacokinetic (PK) profile Measurement of clearance as PK parameter 1 year
Secondary Potential immunogenicity Levels of human anti-GENA-104A16 antibody 1 year
Secondary Objective response rate (ORR) Assessed according to RECIST v1.1 1 year
Secondary Duration of response (DoR) Assessed according to RECIST v1.1 1 year
Secondary Progression free Survival (PFS) Assessed according to RECIST v1.1 1 year
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