NCT06341647

Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201

A Multicenter, Open-label, Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced Human Epidermal Growth Factor Receptor 2 Positive(HER2+) Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GC Cell Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases, which are phase 1a and phase 1b. The primary objective of phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors.

Detailed description

This is a Phase 1, multicenter study designed to evaluate the safety, tolerability, and efficacy of AB-201 in subjects with advanced HER2+ solid tumors (specifically, breast and gastric/GEJ cancers). The Phase 1 will be conducted in two parts, an initial dose escalation stage followed by a dose expansion stage. Study participation for each subject begins with up to 28 days (1 month) of screening following written informed consent, then lymphodepletion treatment, followed by AB-201. Up to 3 doses of AB-201 may be administered. All subjects will be monitored for a total duration of 18 months of follow up from the first dose administration of AB-201.

Conditions

• Breast Cancer
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	AB-201	NK Cell Therapy
DRUG	Cyclophosphamide	Lymphodepleting chemotherapy
DRUG	Fludarabine	Lymphodepleting chemotherapy

Timeline

• Start date: 2024-10-31
• Primary completion: 2027-04-01
• Completion: 2029-02-01
• First posted: 2024-04-02
• Last updated: 2025-01-24