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

NCT06235541 | Withdrawn Phase 1

• 1 other identifier: [GNC] GENA104-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• To determine the MTD and RP2D

  Incidence of dose limiting toxicity (DLT).

  1 year

• Incidence of Adverse Events

  Assessed as per CTCAE v5.0

  1 year

• Incidence of Laboratory abnormalities

  Assessed as per CTCAE v5.0

  1 year

Secondary Outcomes (9)

• Cmax for Pharmacokinetic (PK) profile

  1 year

• Tmax for Pharmacokinetic (PK) profile

  1 year

• AUC0-tlast for Pharmacokinetic (PK) profile

  1 year

• Half-life for Pharmacokinetic (PK) profile

  1 year

• Clearance for Pharmacokinetic (PK) profile

  1 year

Other Outcomes (3)

• Tumor Biospecimens

  1 year

• Blood Biospecimens

  1 year

• Fecal Biospecimens

  1 year

Study Arms (1)

GENA104

EXPERIMENTAL

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.

Drug: GENA-104A16

Interventions

GENA-104A16 DRUG

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.

GENA104

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genome & Company: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Study Officials

• Doyoun Oh

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)