A First-in-human Study of GENA-104A16 in Patients With Advanced Solid Tumors
- Registration Number
- NCT06235541
- Lead Sponsor
- Genome & Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GENA104 GENA-104A16 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.
- Primary Outcome Measures
Name Time Method To determine the MTD and RP2D 1 year Incidence of dose limiting toxicity (DLT).
Incidence of Adverse Events 1 year Assessed as per CTCAE v5.0
Incidence of Laboratory abnormalities 1 year Assessed as per CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Half-life for Pharmacokinetic (PK) profile 1 year Measurement of half-life as PK parameter
Cmax for Pharmacokinetic (PK) profile 1 year Maximum serum concentration
Tmax for Pharmacokinetic (PK) profile 1 year Time to reach the maximum concentration
AUC0-tlast for Pharmacokinetic (PK) profile 1 year The area under the concentration-time curve from the time of dosing (time 0) to the time of the last observation
Clearance for Pharmacokinetic (PK) profile 1 year Measurement of clearance as PK parameter
Potential immunogenicity 1 year Levels of human anti-GENA-104A16 antibody
Duration of response (DoR) 1 year Assessed according to RECIST v1.1
Progression free Survival (PFS) 1 year Assessed according to RECIST v1.1
Objective response rate (ORR) 1 year Assessed according to RECIST v1.1
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of