A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
NCT ID: NCT05678205
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2023-08-01
2027-04-30
Brief Summary
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Subjects will receive up to 3 doses of AB-201, followed by scheduled assessments of overall health and tumor response.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 Dose Confirmation
Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
AB-201
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Phase 2 Cohort A
AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC ≥2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available
AB-201
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Phase 2 Cohort B
AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC 3+ or IHC 2+/ISH+) that is relapsed to, refractory to, or intolerant of previous trastuzumab deruxtecan (T-DXd) based therapy
AB-201
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Phase 2 Cohort C
AB-201 given to patients with advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression (IHC ≥ 2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available
AB-201
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Interventions
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AB-201
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed HER2 expressed breast or gastric/GEJ cancer IHC ≥ 2+ within 6 months prior to study entry.
* Confirmed diagnosis of an advanced/unresectable or metastatic HER2+ breast or gastric/GEJ cancer that is refractory to, or intolerable of standard treatment, or for which no standard treatment is available.
* Must have received prior cancer therapy: Subjects with breast cancer must have received ≥ 2 prior systemic therapies; subjects with gastric/GEJ cancer must have received ≥ 1 prior systemic therapy(ies); subjects with IHC 3+ or IHC 2+/ISH+ cancers must have received previous treatment with a HER2-targeting therapy.
Exclusion Criteria
* Known clinically significant cardiac disease.
* Active central nervous system (CNS) metastases, or involvement of the CNS, unless there is a history of at least 3 months of sustained remission.
* Unresolved toxicities from prior anticancer therapy.
* Ongoing uncontrolled systemic infections requiring antibiotic, anti-fungal, or anti-viral therapy.
* History of sensitivity or intolerance to cyclophosphamide or fludarabine.
* Pregnant or lactating females and subjects of both sexes who are not willing to practice birth control from the time of consent through 6 months after administration of the last AB-201 dose.
* Severe disease progression or health deterioration within 2 weeks prior to lymphodepletion regimen.
18 Years
99 Years
ALL
No
Sponsors
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Artiva Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thorsten Graef, MD, Ph.D
Role: STUDY_DIRECTOR
Artiva Biotherapeutics
Locations
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Oregon Health Science University (OHSU)
Portland, Oregon, United States
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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AB-201-01
Identifier Type: -
Identifier Source: org_study_id
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