Malignant Neoplasm of Stomach, UnspecifiedPhase 1NCT07333820
Clinical Study to Evaluate the Safety and Anti-Tumor Activity of AB-201
A Phase 1 study testing AB-201 Dose escalation in people with Malignant Neoplasm of Stomach, Unspecified, run by Yonsei University at 1 site in South Korea.
Trial summary
HER2 is highly expressed on the surface of several cancer types, including breast and gastric/gastroesophageal junction (GEJ) cancers. Several commercially available HER2-directed oncology therapies exist; however, most patients who initially derive meaningful clinical benefit from these agents eventually relapse or… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Malignant Neoplasm of Stomach, Unspecified
- What is being tested?
- AB-201 Dose escalation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2026to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Signed informed consent.
- Males or females ≥ 19 years of age at the time of informed consent.
- The ECOG performance status 0 to 1.
- Patients with an expected survival of at least 3 months
- Histologically confirmed HER2-expressed gastric/GEJ cancer ≥IHC 1+ within 36 months prior to study entry.
- Confirmed diagnosis (pathologically documented) of an advanced/unresectable or metastatic HER2+ gastric/GEJ cancer that is refractory to, or intolerable of standard treatment, or for which no standard treatment is available.
Show all 27Show fewer
- Prior cancer therapies per the National Comprehensive Cancer Network (NCCN) guidelines
- Subjects with gastric/GEJ cancer must have received ≥ 2 prior systemic therapy(ies)
- Subjects with IHC 3+ or IHC 2+/ISH+ cancers must have received previous treatment with a HER2-targeting therapy
- If the investigator determines no standard treatment remains
- Has adequate treatment washout period prior receiving AB-201, defined as:
- Major surgery ≥ 4 weeks
- Radiation therapy ≥ 4 weeks (if palliative stereotactic radiation therapy without abdominal, ≥ 2 weeks)
- Autologous transplantation ≥ 3 months
- Chemotherapy (including antibody-drug therapy) ≥ 3 weeks (≥ 2 weeks for 5-fluorouracil-based agents, folinate agents and/or weekly paclitaxel. ≥ 6 weeks for nitrosoureas or mitomycin C, > 1 week for TKIs approved for the treatment of breast or gastric/GEJ cancers - baseline computed tomography (CT) scan must be completed after discontinuation of TKI)
- Hormonal therapy ≥ 3 weeks
- Immunotherapy ≥ 4 weeks
- Measurable disease or non-measurable but evaluable disease according to RECIST v1.1, as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), with at least one measurable or non-measurable but evaluable lesion.
- Oxygen saturation via pulse oximeter ≥ 92% at rest on room air
- Left ventricular ejection fraction (LVEF) ≥ 50% and no evidence of pericardial effusion as determined by an echocardiogram (ECHO)/multigated acquisition (MUGA) scan
- Baseline laboratory values fulfilling the following requirements to demonstrate adequate hematologic, renal, and hepatic function:
- Absolute neutrophil count (ANC) ≥ 1000/mm3 (1.0 × 109/L)
- Platelets (PLT) ≥ 75000/mm3 (75 × 109/L)
- Hemoglobin ≥ 8.0 g/dL (transfusions are allowed up to 2 weeks prior to the first AB-201 dose and, as needed, during the treatment period.)
- Creatinine clearance ≥ 45 mL/min using the Cockcroft-Gault equation, or an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73m2 per Modification of Diet in Renal Disease (MDRD) equation
- Total serum bilirubin < 2.5 mg/dL (< 5 mg/dL for subjects with known Gilbert's Syndrome)
- Liver transaminases (AST/ALT/ALP) ≤ 3 × ULN; subjects with liver metastases may have AST, ALT, and ALP ≤ 5 × ULN
Who cannot join
- Active CNS metastases, or involvement of the CNS, unless there is a history of at least 3 months of sustained remission of treated disease and no change in steroid dose for at least 28 days prior to study entry.
- Known past or current malignancy other than inclusion diagnosis, except for:
- Cervical carcinoma of stage 1B or less
- Noninvasive basal cell or squamous cell skin carcinoma
- Noninvasive, superficial bladder cancer
- Prostate cancer with a current PSA level < 0.1 ng/mL
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- Any curable cancer with a CR duration of > 2 years
- Enrollment of other malignancies is allowed at the investigator's discretion.
- Known clinically significant cardiac disease, including:
- Onset of unstable angina pectoris within 6 months of signing the informed consent form
- Acute myocardial infarction within 6 months of signing the informed consent form
- Congestive heart failure (grade II or III or IV as classified by the New York Heart Association)
- Impaired cardiac function (LVEF < 50%) as assessed by echocardiogram or MUGA scan
- Subjects with uncontrolled arrhythmia or hypertension
- Subjects with cardiac valvular disease
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved per the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) to Grade ≤ 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia, vitiligo, and laboratory test values that otherwise meet inclusion criteria.
- Ongoing uncontrolled systemic infections requiring antibiotic, anti-fungal, or anti-viral therapy.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, based on laboratory testing performed during screening period. HBV-infected subjects are considered eligible if their viral load is below the institutional limit of quantification (LOQ) and the subject is on stable viral suppressive therapy. HCV infected subjects are considered eligible if they have completed curative antiviral treatment and their HCV RNA viral load is below the institutional LOQ
- Live vaccine administration planned or required during the treatment period of the trial.
- History of sensitivity or intolerance to cyclophosphamide or fludarabine.
- Female subjects of childbearing potential, unable or unwilling to use appropriate contraception (e.g., any combination of condom, diaphragm, intrauterine devices [IUDs], and hormonal oral contraceptives or male partner vasectomy) for the duration of the trial and for 6 months following the last dose of AB-201.
- Male subjects must be sterile (biologically or surgically) or commit to the use of a highly effective method of contraception (any approved combination of physical or chemical methods) until at least 6 months following administration of the last AB-201 dose.)
- Currently pregnant or lactating (breast feeding must not be started within 6 months of the last dose of AB 201).
- Any other considerations that might interfere with the assessment of safety or efficacy, or that the investigator deems inappropriate for inclusion.
- History or presence of a clinically relevant CNS disorder such as seizure disorder (e.g., epilepsy), cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome (PRES), or any autoimmune disease with CNS involvement.
- Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and granting informed consent.
- Severe disease progression or health deterioration within 2 weeks prior to lymphodepletion regimen that, in the opinion of the Investigator, could impair the ability of the subject to receive study treatment or comply with study requirements.
- Subjects who have undergone organ transplantation
- Subjects with a history of receiving one or more immune cell therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2 Positive Gastric/Gastroesophageal Junction(GEJ) Cancer
HER2 is highly expressed on the surface of several cancer types, including breast and gastric/gastroesophageal junction (GEJ) cancers. Several commercially available HER2-directed oncology therapies exist; however, most patients who initially derive meaningful clinical benefit from these agents eventually relapse or experience disease progression. Accordingly, the development of safe and effective treatments for patients who have exhausted current HER2-directed options remains an important unmet medical need.
AB-201 has demonstrated direct, HER2-specific, and potent cytotoxicity against multiple tumor cell lines both in vitro and in vivo. In addition, AB-201 has shown the ability to secrete cytokines, including tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), upon activation. Based on this emerging HER2-targeted cell therapy dataset, a HER2 CAR-NK therapy such as AB-201 may offer a safe, active, and readily available treatment option for patients with HER2-positive solid tumors.
This clinical trial will enroll subjects with HER2-positive gastric/GEJ cancers. The primary objective of the study is to evaluate the safety and tolerability of AB-201 in subjects with advanced HER2-positive gastric/GEJ cancers. The secondary objective is to assess the preliminary efficacy of AB-201, measured by objective response rate (ORR) per RECIST v1.1, in subjects with advanced gastric/GEJ cancers.
Read the detailed description
Study designed to evaluate the safety, tolerability, and efficacy of AB-201 in subjects with advanced HER2 positive gastric/GEJ cancers.
Up to 18 subjects will be enrolled, and the study will be conducted by dose escalation.
During the Dose Escalation stage of this study, up to 3 escalating dose levels of AB-201 will be explored. The maximum tolerated dose (MTD) and/or maximum administered dose (MAD) for AB-201 will be defined as the highest dose level at which not more than 1 of 6 subjects in a cohort experiences a dose-limiting toxicity (DLT) as outlined below. The highest dose administered becomes the MAD if the MTD is not reached.
AB-201 is a cryopreserved, infusion-ready suspension cell therapy comprised of ex vivo-expanded allogeneic cord blood-derived NK cells that have been genetically modified to express a HER2-directed CAR and secrete IL-15.
AB-201 will be administered as a single IV infusion starting at 48 hours (but no more than 7 days) after completion of the lymphodepletion regimen. A 28-day observation period will then occur, at the end of which all relevant safety data will be reviewed.
Study participation for each subject begins with up to 28 days (1 month) of screening following written informed consent, then lymphodepletion treatment, followed by AB-201. All subjects will be monitored for a total duration of 18 months of follow-up from the administration of AB-201.
Safety will be assessed according to the Schedule of Activities by monitoring AEs (including DLTs, AEs of special interest [AESIs], and serious AEs [SAEs]), concomitant medications, physical examinations, ECOG performance status, acute GvHD, vital signs, and laboratory test findings. As an additional safety measure, Bayesian stopping bounds will be employed for the duration of the study.
Disease assessments will be performed according to the Schedule of Activities per RECIST v1.1. Imaging scans (CT or MRI) will be performed at Months 1, 2, 3, 6, 9, 12, 15, and 18 for efficacy assessments.
- Being tested
- AB-201 Dose escalation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-201 Dose escalationDrug
- Lymphodepletion Before administration of of AB-201, subjects will receive a lymphodepleting regimen consisting of cyclophosphamide (500 mg/m2/day IV) and fludarabine (30 mg/m2/day IV) to induce lymphocyte depletion and create an optimal environment for expansion of AB-201 in vivo. However, the lymphodepletion regimen may be adjusted according to the regulations of the institution or at the discretion of the principal investigator.
- AB-201 Administration A total of one dose of AB-201 (adjusted for a subject's body weight) as IV infusions are planned during the treatment phase.
<Dose Levels for AB-201(adjusted for a subject's body weight)>
- Starting dose: 5.0 × 10^5 cells/kg
- 1.5 × 10^6 cells/kg
- 5.0 × 10^6 cells/kg
| Study group | Role | What they receive |
|---|---|---|
| AB-201 Dose escalation | Experimental | * Drug: AB-201
* Drug: Cyclophosphamide
* Drug: Fludarabine Receives: Drug: AB-201 Dose escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Tolerability (Incidence, severity, seriousness, and dose relationship of Adverse Events)
Adverse events and laboratory abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: Up to 18 monthes per patient
Secondary outcomes (1)
Preliminary efficacy, by the objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
The proportion of subjects who experienced an PR or CR, as assessed by investigators per RECIST v1.1.
Measured: Up to 18 monthes per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of Stomach, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333820
- Sponsor's protocol ID
- 4-2025-0975
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 12 Jan 2026
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2 Positive Gastric/Gastroesophageal Junction(GEJ) Cancer
- ClinicalTrials.gov ID
- NCT07333820
- Acronym / sponsor ID
- 4-2025-0975
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 12 Jan 2026 (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.
HER2 is highly expressed on the surface of several cancer types, including breast and gastric/gastroesophageal junction (GEJ) cancers. Several commercially available HER2-directed oncology therapies exist; however, most patients who initially derive meaningful clinical benefit from these agents eventually relapse or experience disease progression. Accordingly, the development of safe and effective treatments for patients who have exhausted current HER2-directed options remains an important unmet medical need.
AB-201 has demonstrated direct, HER2-specific, and potent cytotoxicity against multiple tumor cell lines both in vitro and in vivo. In addition, AB-201 has shown the ability to secrete cytokines, including tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), upon activation. Based on this emerging HER2-targeted cell therapy dataset, a HER2 CAR-NK therapy such as AB-201 may offer a safe, active, and readily available treatment option for patients with HER2-positive solid tumors.
This clinical trial will enroll subjects with HER2-positive gastric/GEJ cancers. The primary objective of the study is to evaluate the safety and tolerability of AB-201 in subjects with advanced HER2-positive gastric/GEJ cancers. The secondary objective is to assess the preliminary efficacy of AB-201, measured by objective response rate (ORR) per RECIST v1.1, in subjects with advanced gastric/GEJ cancers.
Detailed description
Study designed to evaluate the safety, tolerability, and efficacy of AB-201 in subjects with advanced HER2 positive gastric/GEJ cancers.
Up to 18 subjects will be enrolled, and the study will be conducted by dose escalation.
During the Dose Escalation stage of this study, up to 3 escalating dose levels of AB-201 will be explored. The maximum tolerated dose (MTD) and/or maximum administered dose (MAD) for AB-201 will be defined as the highest dose level at which not more than 1 of 6 subjects in a cohort experiences a dose-limiting toxicity (DLT) as outlined below. The highest dose administered becomes the MAD if the MTD is not reached.
AB-201 is a cryopreserved, infusion-ready suspension cell therapy comprised of ex vivo-expanded allogeneic cord blood-derived NK cells that have been genetically modified to express a HER2-directed CAR and secrete IL-15.
AB-201 will be administered as a single IV infusion starting at 48 hours (but no more than 7 days) after completion of the lymphodepletion regimen. A 28-day observation period will then occur, at the end of which all relevant safety data will be reviewed.
Study participation for each subject begins with up to 28 days (1 month) of screening following written informed consent, then lymphodepletion treatment, followed by AB-201. All subjects will be monitored for a total duration of 18 months of follow-up from the administration of AB-201.
Safety will be assessed according to the Schedule of Activities by monitoring AEs (including DLTs, AEs of special interest [AESIs], and serious AEs [SAEs]), concomitant medications, physical examinations, ECOG performance status, acute GvHD, vital signs, and laboratory test findings. As an additional safety measure, Bayesian stopping bounds will be employed for the duration of the study.
Disease assessments will be performed according to the Schedule of Activities per RECIST v1.1. Imaging scans (CT or MRI) will be performed at Months 1, 2, 3, 6, 9, 12, 15, and 18 for efficacy assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AB-201 Dose escalation | Experimental | Drug: AB-201 Dose escalation* Drug: AB-201 * Drug: Cyclophosphamide * Drug: Fludarabine |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Signed informed consent.
- Males or females ≥ 19 years of age at the time of informed consent.
- The ECOG performance status 0 to 1.
- Patients with an expected survival of at least 3 months
- Histologically confirmed HER2-expressed gastric/GEJ cancer ≥IHC 1+ within 36 months prior to study entry.
Key exclusion criteria (29 listed)
- Active CNS metastases, or involvement of the CNS, unless there is a history of at least 3 months of sustained remission of treated disease and no change in steroid dose for at least 28 days prior to study entry.
- Known past or current malignancy other than inclusion diagnosis, except for:
- Known clinically significant cardiac disease, including:
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved per the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) to Grade ≤ 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia, vitiligo, and laboratory test values that otherwise meet inclusion criteria.
- Ongoing uncontrolled systemic infections requiring antibiotic, anti-fungal, or anti-viral therapy.
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 |
|---|---|---|
| AB-201 Dose escalation1. Lymphodepletion Before administration of of AB-201, subjects will receive a lymphodepleting regimen consisting of cyclophosphamide (500 mg/m2/day IV) and fludarabine (30 mg/m2/day IV) to induce lymphocyte depletion and create an optimal environment for expansion of AB-201 in vivo. However, the lymphodepletion regimen may be adjusted according to the regulations of the institution or at the discretion of the principal investigator. 2. AB-201 Administration A total of one dose of AB-201 (adjusted for a subject's body weight) as IV infusions are planned during the treatment phase. <Dose Levels for AB-201(adjusted for a subject's body weight)> 1. Starting dose: 5.0 × 10^5 cells/kg 2. 1.5 × 10^6 cells/kg 3. 5.0 × 10^6 cells/kg | Drug | AB-201 Dose escalation |
Primary outcome
Safety & Tolerability (Incidence, severity, seriousness, and dose relationship of Adverse Events)
Time frame: Up to 18 monthes per patient
Adverse events and laboratory abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
1 secondary outcome
Preliminary efficacy, by the objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
Time frame: Up to 18 monthes per patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 AB-201 Dose escalation in people with Malignant Neoplasm of Stomach, Unspecified, run by Yonsei University 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 27 inclusion and 29 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: opening soon, as of the sponsor's last update on 12 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety & Tolerability (Incidence, severity, seriousness, and dose relationship of Adverse Events) (time frame: Up to 18 monthes per patient). 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 12 Jan 2026.