A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer

Phase 1 Completed 73 enrolled Fujifilm Pharmaceuticals U.S.A., Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and tolerability in subjects who receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors.

Timeline

Start: 2016-01
Primary completion: 2021-10
Completion: 2021-10

Outcome

Missed primary endpoint

paper 90Y-FF-21101 did not meet the predefined efficacy criteria PMID 39748726 ↗

Publications

Mahalingam D, Owonikoko TK, Delpassand E, Mulcahy MF, Kalyan A, Ulahannan S, Cheung K, Izumi Y, Johansen M, Madden T, Shimoyama S, Subach RA, Suzuki T, Wages DS, Wheeler C, Richardson DL. A trial of radiolabeled antibody yttrium-90-FF-21101 for the treatment of advanced ovarian and other cancers. Cancer. 2025 Jan 1;131(1):e35680. doi: 10.1002/cncr.35680.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FF21101	Monoclonal antibody	25 unknown	Intravenous