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

Sponsor

Artiva Biotherapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05678205

Collaborator

(none)

133

Enrollment

Locations

Arms

Anticipated Duration (Months)

66.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Gastric Cancer Gastroesophageal Junction Adenocarcinoma	Drug: AB-201 Drug: Cyclophosphamide Drug: Fludarabine	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

133 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2027

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1 Dose Confirmation Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression	Drug: AB-201 NK Cell Therapy Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy
Experimental: Phase 2 Cohort A AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC ≥2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available	Drug: AB-201 NK Cell Therapy Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy
Experimental: Phase 2 Cohort B AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC 3+ or IHC 2+/ISH+) that is relapsed to, refractory to, or intolerant of previous trastuzumab deruxtecan (T-DXd) based therapy	Drug: AB-201 NK Cell Therapy Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy
Experimental: Phase 2 Cohort C AB-201 given to patients with advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression (IHC ≥ 2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available	Drug: AB-201 NK Cell Therapy Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy

Outcome Measures

Primary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health Science University (OHSU)	Portland	Oregon	United States	97239
2	The Catholic University of Korea, St. Vincent's Hospital	Suwon	Gyeonggi-do	Korea, Republic of	16247

Sponsors and Collaborators

Artiva Biotherapeutics, Inc.

Investigators

Study Director: Thorsten Graef, MD, Ph.D, Artiva Biotherapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Artiva Biotherapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT05678205

Other Study ID Numbers:

AB-201-01

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 13, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Cyclophosphamide

Fludarabine

Study Results

No Results Posted as of Jan 13, 2023