A First-in-human Study of GENA-104A16 in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06235541
• Other study ID #: [GNC] GENA104-101
• Status: Not yet recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

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