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

NCT05678205 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: AB-201-01
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Breast Cancer; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (4)

Phase 1 Dose Confirmation

EXPERIMENTAL

Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression

Drug: AB-201; Drug: Cyclophosphamide; Drug: Fludarabine

Phase 2 Cohort A

EXPERIMENTAL

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; Drug: Cyclophosphamide; Drug: Fludarabine

Phase 2 Cohort B

EXPERIMENTAL

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; Drug: Cyclophosphamide; Drug: Fludarabine

Phase 2 Cohort C

EXPERIMENTAL

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; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

AB-201 DRUG

NK Cell Therapy

Phase 1 Dose Confirmation; Phase 2 Cohort A; Phase 2 Cohort B; Phase 2 Cohort C

Cyclophosphamide DRUG

Lymphodepleting chemotherapy

Phase 1 Dose Confirmation; Phase 2 Cohort A; Phase 2 Cohort B; Phase 2 Cohort C

Fludarabine DRUG

Lymphodepleting chemotherapy

Phase 1 Dose Confirmation; Phase 2 Cohort A; Phase 2 Cohort B; Phase 2 Cohort C

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Artiva Biotherapeutics, Inc.: lead

Study Sites (2)

Oregon Health Science University (OHSU)

Portland, Oregon, 97239, United States

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Stomach Neoplasms

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Thorsten Graef, MD, Ph.D

  Artiva Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); KR (1)