Breast Cancer Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 133 |
Est. completion date | April 2027 |
Est. primary completion date | April 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggi-do |
United States | Oregon Health Science University (OHSU) | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Artiva Biotherapeutics, Inc. |
United States, Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: incidence and severity of adverse events and serious adverse events | From the time of consent through End of Study (up to 18 months per patient) | ||
Primary | Determination of Recommended Phase 2 Dose (RP2D): safety, preliminary efficacy (based on objective response rate (ORR) defined as the proportion of patients with a complete or partial response) and pharmacokinetics | From the time of consent through End of Study (up to 18 months per patient) | ||
Primary | Efficacy: Objective Response Rate, defined as the proportion of patients with a complete or partial response | From the time of consent through End of Study (up to 18 months per patient) |
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