A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors

Sponsor: Artiva Biotherapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05678205

Patient View

This trial assesses AB-201's safety and efficacy in advanced HER2+ tumors. Eligible participants have HER2+ breast or gastric/GEJ cancer, ECOG 0-1, and prior therapy. Interventions include AB-201 (NK cell therapy) and lymphodepleting chemotherapy with cyclophosphamide and fludarabine. Participants receive up to 3 doses, with health and tumor response evaluations.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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.

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