NCT06341647 is a Phase 1 clinical trial of AB-201 in Breast Cancer, sponsored by GC Cell Corporation.

Who is sponsoring NCT06341647?

NCT06341647 is sponsored by GC Cell Corporation.

What drugs are being tested in NCT06341647?

Interventions in NCT06341647: AB-201, Cyclophosphamide, Fludarabine.

What condition does NCT06341647 study?

NCT06341647 studies Breast Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma.

Is NCT06341647 still recruiting?

NCT06341647 is currently withdrawn. Last updated 22 January 2025.

Last reviewed 2025-01-22 · How we verify

NCT06341647

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Withdrawn Phase 1 Last updated 22 January 2025

What this trial tests

Phase 1 trial testing AB-201 in Breast Cancer. Withdrawn.

Timeline

31 October 2024

Primary endpoint
1 April 2027

1 February 2029

Quick facts

Lead sponsor	GC Cell Corporation
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Start date	31 October 2024
Primary completion	1 April 2027
Estimated completion	1 February 2029

Drugs / interventions tested

AB-201 — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Gastric Cancer — all drugs for Gastric Cancer →
Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →

Sponsor

GC Cell Corporation — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability]
Time frame: up to 18 months per patient
Adverse events and laboratory abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Determination of Recommended Phase 2 Dose (RP2D)
Time frame: up to 18 months per patient
Assessment of Dose-Limiting Toxicities(DLTs), pharmacokinetics (PK), safety, and objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 in subjects with HER2+ breast cancer and gastric/GEJ cancer. PK: Monitor persistence of AB-201 in subjects samples collected prior to and following AB-201 administration.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other GC Cell Corporation trials

Trials by the same sponsor.

NCT06620510 — Retrospective Study of Long-Term Survival of "Immuncell-LC" in Patients Undergoing Curative Resection for HCC in Korea · completed
NCT05238532 — Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS · Phase 1 · withdrawn
NCT05258331 — Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Psoriasis · Phase 1 · unknown
NCT03983967 — Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation · Phase 1, PHASE2 · completed
NCT03778619 — MG4101 Plus Rituximab Including Lymphodepletion in Patient With r/r NHL B-cell Origin · Phase 1, PHASE2 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06341647 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GC Cell Corporation
Last refreshed: 22 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06341647.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing