NCT05527184

First in Human Study of IMGN151 in Recurrent Gynaecological Cancers

A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (Anti-FRα Antibody-drug Conjugate) in Adult Patients With Recurrent Gynaecological Cancers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

IIMGN151-1001 is a Phase 1, first in human, open-label dose-escalation, optimization, and expansion study designed to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of IMGN151 in adult participants with recurrent endometrial cancer; recurrent, high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers; or recurrent cervical cancers. All participants will be, in the opinion of the investigator, appropriate for nonplatinum single-agent therapy for their next line of therapy.

Detailed description

Participants may continue on study drug based on clinical benefit until disease progression, adverse event (AE) requiring discontinuation, withdrawal of consent, physician decision, or other discontinuation criteria are met.

Conditions

• Endometrial Cancer
• High Grade Serous Adenocarcinoma of Ovary
• Primary Peritoneal Carcinoma
• Fallopian Tube Cancer
• Cervical Cancer

Interventions

Type	Name	Description
DRUG	IMGN151	IMGN151 is an antibody-drug conjugate (ADC).

Timeline

• Start date: 2023-01-11
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2022-09-02
• Last updated: 2026-02-20

Locations

58 sites across 10 countries: United States, Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study