Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Summary

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

Timeline

Start

2011-04

Primary completion

2015-06

Completion

2015-06

Outcome

Missed primary endpoint

Stopped (Enrollment): “Total number of pts expected to be enrolled would not be met.”

paper The trial was terminated early since it was unlikely that the primary objective would be achieved. PMID 33664128 ↗

Publications

• Smaletz O, Ismael G, Del Pilar Estevez-Diz M, Nascimento ILO, de Morais ALG, Cunha-Junior GF, Azevedo SJ, Alves VA, Moro AM, Yeda FP, Dos Santos ML, Majumder I, Hoffman EW. Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission. Int J Gynecol Cancer. 2021 Apr;31(4):562-568. doi: 10.1136/ijgc-2020-002239. Epub 2021 Mar 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	hu3S193	Monoclonal antibody	30 mg/m2	Intravenous

Indications