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Spots Global Cancer Trial Database for Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201

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Trial Identification

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

Official Title: 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

Study ID: NCT06341647

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

The Alfred Hosptial, Melbourne, Victoria, Australia

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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