A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
Key facts
- Who runs it
- Artiva Biotherapeutics, Inc.
- Where
- Portland, United StatesSee the siteAlso in 1 other country, 1 site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 1/2
- Started
- 1 Aug 2023
- Expected to end
- Apr 2027
- Type of study
- Interventional, 4 groups
- Treatments tested
- AB-201
- Cyclophosphamide
- Fludarabine
- Record updated
- 30 July 2025
- Why it stopped
- Corporate business decision
Who can take part
- Age
- 18 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- ECOG performance status 0 to 1
- 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
Who cannot take part
- Unresolved toxicities from prior anticancer therapy
- Severe disease progression or health deterioration within 2 weeks prior to lymphodepletion regimen
- Known past or current malignancy other than inclusion diagnosis
- 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
- 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
Where in United States
Also in 1 other country, 1 site
- Oregon Health & Science University (OHSU)Portland, United StatesNo longer taking part
About the trial
What the trial wants to find out
This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases. The primary objective of Phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors. The primary objective of Phase 2 is to evaluate the efficacy of AB-201.
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Subjects will receive up to 3 doses of AB-201, followed by scheduled assessments of overall health and tumor response.
The 4 groups in the trial
- Phase 1 Dose ConfirmationTreatment being tested
Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
Treatment: AB-201, Cyclophosphamide, and Fludarabine
- Phase 2 Cohort ATreatment being tested
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
Treatment: AB-201, Cyclophosphamide, and Fludarabine
- Phase 2 Cohort BTreatment being tested
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
Treatment: AB-201, Cyclophosphamide, and Fludarabine
- Phase 2 Cohort CTreatment being tested
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
Treatment: AB-201, Cyclophosphamide, and Fludarabine
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multicenter, Open-label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
- Record updated
- 30 July 2025