Clinical trial NCT06235541: A First-in-human Study of GENA-104A16 in Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Genome & Company
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To determine the MTD and RP2D
timeFrame: 1 year
measure: Incidence of Adverse Events
timeFrame: 1 year
measure: Incidence of Laboratory abnormalities
timeFrame: 1 year
Secondary outcomes:
measure: Cmax for Pharmacokinetic (PK) profile
timeFrame: 1 year
measure: Tmax for Pharmacokinetic (PK) profile
timeFrame: 1 year
measure: AUC0-tlast for Pharmacokinetic (PK) profile
timeFrame: 1 year
measure: Half-life for Pharmacokinetic (PK) profile
timeFrame: 1 year
measure: Clearance for Pharmacokinetic (PK) profile
timeFrame: 1 year
measure: Potential immunogenicity
timeFrame: 1 year
measure: Objective response rate (ORR)
timeFrame: 1 year
measure: Duration of response (DoR)
timeFrame: 1 year
measure: Progression free Survival (PFS)
timeFrame: 1 year
Other outcomes:
measure: Tumor Biospecimens
timeFrame: 1 year
measure: Blood Biospecimens
timeFrame: 1 year
measure: Fecal Biospecimens
timeFrame: 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Doyoun Oh
role: PRINCIPAL_INVESTIGATOR
References: