A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Breast Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
In brief
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. Subjects will receive up to 3 doses of AB-201, followed by scheduled assessments of overall health and tumor response.
Key facts
- Study ID
- NCT05678205
- Run by
- Artiva Biotherapeutics, Inc.
- People needed
- 0
- Starts
- 2023-08-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2025-07-30
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- 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.
Where it is running
- Oregon Health Science University (OHSU) — Portland, Oregon, United States
- The Catholic University of Korea, St. Vincent's Hospital — Suwon, Gyeonggi-do, South Korea
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.