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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05678205
Other study ID # AB-201-01
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2023
Est. completion date April 2027

Study information

Verified date January 2023
Source Artiva Biotherapeutics, Inc.
Contact AB-201-01 Study Team
Phone 858-267-4465
Email AB-201-01StudyTeam@ArtivaBio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AB-201
NK Cell Therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Artiva Biotherapeutics, Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

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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