Clinical Study to Evaluate the Safety and Anti-Tumor Activity of AB-201 (NCT07333820) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Study to Evaluate the Safety and Anti-Tumor Activity of AB-201
South Korea18 participantsStarted 2026-02
Plain-language 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 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Prior cancer therapies per the National Comprehensive Cancer Network (NCCN) guidelines
✓. Subjects with gastric/GEJ cancer must have received ≥ 2 prior systemic therapy(ies)
Exclusion criteria
✕. 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.
What they're measuring
1
Safety & Tolerability (Incidence, severity, seriousness, and dose relationship of Adverse Events)