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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05678205
• Other study ID #: AB-201-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Cancer
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

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)