Advanced Solid TumorsPhase 1NCT06235541
A First-in-human Study of GENA-104A16 in Patients With Advanced Solid Tumors
A Phase 1 study testing GENA-104A16 in people with Advanced Solid Tumors, run by Genome & Company at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- GENA-104A16
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2024to May 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
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
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
- Being tested
- GENA-104A16
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENA-104A16Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GENA-104A16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the MTD and RP2D
Incidence of dose limiting toxicity (DLT).
Measured: 1 year
Incidence of Adverse Events
Assessed as per CTCAE v5.0
Measured: 1 year
Incidence of Laboratory abnormalities
Assessed as per CTCAE v5.0
Measured: 1 year
Secondary outcomes (9)
Cmax for Pharmacokinetic (PK) profile
Maximum serum concentration
Measured: 1 year
Tmax for Pharmacokinetic (PK) profile
Time to reach the maximum concentration
Measured: 1 year
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
Measured: 1 year
Half-life for Pharmacokinetic (PK) profile
Measurement of half-life as PK parameter
Measured: 1 year
Clearance for Pharmacokinetic (PK) profile
Measurement of clearance as PK parameter
Measured: 1 year
Potential immunogenicity
Levels of human anti-GENA-104A16 antibody
Measured: 1 year
Objective response rate (ORR)
Assessed according to RECIST v1.1
Measured: 1 year
Duration of response (DoR)
Assessed according to RECIST v1.1
Measured: 1 year
Progression free Survival (PFS)
Assessed according to RECIST v1.1
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genome & Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doyoun Oh, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235541
- Sponsor's protocol ID
- [GNC] GENA104-101
- Status last verified
- Jul 2025
- First submitted
- 15 Jan 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06235541
- Acronym / sponsor ID
- [GNC] GENA104-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genome & CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENA104 | Experimental | Drug: GENA-104A1680 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GENA-104A16GENA-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. | Drug | GENA104 |
Primary outcome
To determine the MTD and RP2D
Time frame: 1 year
Incidence of dose limiting toxicity (DLT).
Incidence of Adverse Events
Time frame: 1 year
Assessed as per CTCAE v5.0
Incidence of Laboratory abnormalities
Time frame: 1 year
Assessed as per CTCAE v5.0
9 secondary outcomes
Cmax for Pharmacokinetic (PK) profile
Time frame: 1 year
Tmax for Pharmacokinetic (PK) profile
Time frame: 1 year
AUC0-tlast for Pharmacokinetic (PK) profile
Time frame: 1 year
Half-life for Pharmacokinetic (PK) profile
Time frame: 1 year
Clearance for Pharmacokinetic (PK) profile
Time frame: 1 year
Potential immunogenicity
Time frame: 1 year
Objective response rate (ORR)
Time frame: 1 year
Duration of response (DoR)
Time frame: 1 year
Progression free Survival (PFS)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doyoun Oh principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GENA-104A16 in people with Advanced Solid Tumors, run by Genome & Company at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the MTD and RP2D (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.