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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
256
IMGN151 is an antibody-drug conjugate (ADC).
University of Alabama at Birmingham /ID# 269045
Birmingham, Alabama, United States
City of Hope National Medical Center /ID# 269036
Duarte, California, United States
Moores Cancer Center /ID# 269040
La Jolla, California, United States
University of California Los Angeles Medical Center /ID# 269037
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian /ID# 269047
Newport Beach, California, United States
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to approximately 3 years
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Day 21 of Cycle 1 (Cycle length = 3 weeks)
Recommended Dose of IMGN151 Monotherapy
Time frame: Up to approximately 2 years
Maximum Observed Plasma Concentration (Cmax) of IMGN151
Time frame: Up to approximately 3 years
Time to Reach Cmax (Tmax) of IMGN151
Time frame: Up to approximately 3 years
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of IMGN151
Time frame: Up to approximately 3 years
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs)
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with best response of complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame: Up to approximately 3 years
Duration of Response (DOR)
DOR is defined as the time from initial response (CR or PR) until radiological progressive disease (PD), as assessed by the investigator, or death, whichever occurs first per RECIST v1.1 criteria.
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UCHSC Anschultz Cancer Pavilion /ID# 269056
Aurora, Colorado, United States
AdventHealth Celebration /ID# 269030
Kissimmee, Florida, United States
Mount Sinai Medical Center /ID# 269050
Miami, Florida, United States
Miami Cancer Institute at Baptist Health /ID# 269041
Miami, Florida, United States
Florida Cancer Specialists- Sarasota Cattlemen /ID# 269055
Sarasota, Florida, United States
...and 48 more locations