About this trial
IMGN151-1001 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.
Patient Profile
Inclusion Criteria:
– Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
– Dose-Escalation Phase: Recurrent endometrial cancer or high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC) and who have exhausted appropriate standard-of-care therapy.
– Dose Optimization: Platinum-resistant, high-grade serous EOC (PROC) with no previous folate receptor alpha (FRα)-directed therapy. Participants with PROC will have had no more than 5 prior lines of therapy, with no more than 2 prior therapies since development of platinum resistance.
Where’s this trial being run?
Mater Misericordiae University Hospital
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | IMGN 151-001: First in Human Study of IMGN151 in Recurrent Gynaecological Cancers |
|---|---|
| Number: | 24-06 |
| Full Title: | 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 |
| Principal Investigator: | Prof Austin Duffy (START, MMUH) |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | AbbVie |
| Recruitment Started: |
Global: Ireland: |
| Global Recruitment Target: | 423 |
|---|---|
| Ireland Recruitment Target: |