Advanced Solid Tumors
Conditions
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.
Interventions
DRUGGENA-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
Genome & Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 1 year | Assessed as per CTCAE v5.0 |
| To determine the MTD and RP2D | 1 year | Incidence of dose limiting toxicity (DLT). |
| Incidence of Laboratory abnormalities | 1 year | Assessed as per CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Half-life for Pharmacokinetic (PK) profile | 1 year | Measurement of half-life as PK parameter |
| Potential immunogenicity | 1 year | Levels of human anti-GENA-104A16 antibody |
| Objective response rate (ORR) | 1 year | Assessed according to RECIST v1.1 |
| Duration of response (DoR) | 1 year | Assessed according to RECIST v1.1 |
| Progression free Survival (PFS) | 1 year | Assessed according to RECIST v1.1 |
| Clearance for Pharmacokinetic (PK) profile | 1 year | Measurement of clearance 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tumor Biospecimens | 1 year | Levels of biomarkers expression with the observed antitumor activity |
| Fecal Biospecimens | 1 year | Levels of biomarkers expression with the observed antitumor activity |
| Blood Biospecimens | 1 year | Levels of biomarkers expression with the observed antitumor activity |
Countries
South Korea
Outcome results
None listed