Breast Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Conditions
Brief summary
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.
Interventions
DRUGAB-201
NK Cell Therapy
DRUGCyclophosphamide
Lymphodepleting chemotherapy
DRUGFludarabine
Lymphodepleting chemotherapy
Sponsors
Artiva Biotherapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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) |
Countries
South Korea, United States
Outcome results
None listed