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Monoclonal Antibodies
IMGN151 for Ovarian Cancer
Phase 1
Recruiting
Research Sponsored by ImmunoGen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial tests a new drug to treat recurrent endometrial, ovarian, peritoneal, and fallopian tube cancers in adults.
Who is the study for?
Adults with recurrent endometrial, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancers can join this trial. They must have had prior therapy and be in good health with proper organ function. Those who are pregnant, breastfeeding, or have certain other medical conditions like uncontrolled hypertension or recent strokes cannot participate.Check my eligibility
What is being tested?
The study is testing IMGN151's safety and effectiveness for patients with specific recurrent cancers. It's a first-in-human study where the dosage will be increased gradually to find the optimal safe amount before expanding to more participants.See study design
What are the potential side effects?
As this is a first-in-human study of IMGN151, potential side effects are not fully known but may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize Safety (Escalation)
Define Recommended Phase 2 Dose (Escalation)
Determine Objective Response Rate (Expansion)
Secondary outcome measures
During dose escalation and expansion to characterize study drug concentration
During dose escalation and expansion to measure the concentration of anti-drug antibody
During dose escalation to describe the objective response rate and duration of response
+2 moreOther outcome measures
Determine Progression Free Survival (Escalation)
Trial Design
1Treatment groups
Experimental Treatment
Group I: IMGN151 Open LabelExperimental Treatment1 Intervention
IMGN151 is administered via intravenous (IV) infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter, at the assigned dose for each cohort during dose escalation, and at the RP2D for expansion. Infusion duration will vary depending on dose and participant tolerability.
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Who is running the clinical trial?
ImmunoGen, Inc.Lead Sponsor
32 Previous Clinical Trials
3,604 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,013 Patients Enrolled for Ovarian Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses or active infections.I have had cancer other than my current one in the last 3 years.I have a serious heart condition.I have previously been treated with a drug targeting FRα.I am willing to provide a sample of my tumor for testing.I do not have severe numbness or pain in my hands or feet.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I have had extensive radiation therapy affecting a large part of my bone marrow.I have recurrent endometrial cancer or a specific type of ovarian, peritoneal, or fallopian tube cancer.I have a history of multiple sclerosis, Lambert-Eaton syndrome, or similar conditions.I had major surgery over 4 weeks ago and have recovered from it.I have brain metastases that are either untreated or causing symptoms.I have been diagnosed with recurrent endometrial cancer or high-grade ovarian, peritoneal, or fallopian tube cancer.I have severe liver disease.I need to take supplements that contain folate.I am not pregnant or breastfeeding.My ovarian cancer is of a specific type (endometrioid, clear cell, mucinous, sarcomatous, or low-grade).I agree to use effective birth control during and for 3 months after my treatment.I have had lung inflammation or a specific lung disease without infection.My blood, liver, and kidney functions are all within normal ranges.I have recovered from side effects of previous treatments, except for hair loss.I have at least one tumor that can be measured with a scan.
Research Study Groups:
This trial has the following groups:- Group 1: IMGN151 Open Label
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary aims of this clinical assessment?
"This clinical trial will assess safety over a period of up to 1 year, and its secondary objectives include measuring Progression Free Survival, Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of IMGN151, Total B5327A Antibody, Free DM51 and S-Methyl DM51 pharmacokinetic parameters. Additionally the study seeks to determine Duration of Response."
Answered by AI
What is the proposed sample size for this clinical trial?
"Yes, according to clinicaltrials.gov, this research is currently in the process of recruiting 227 volunteers from a single medical centre. The study was first posted on December 6th 2022 and has since been updated with fresh data."
Answered by AI
Has the Food and Drug Administration officially authorized unblinded use of IMGN151?
"Due to the limited clinical data supporting safety and efficacy, IMGN151 Open Label has been rated a 1 on our team's scale of risk."
Answered by AI
Is this clinical experiment recruiting participants at present?
"Affirmative. Evidence on clinicaltrials.gov confirms that this medical experiment, initially posted on December 6th 2022, is actively searching for participants. Specifically, 227 patients need to be recruited from one site."
Answered by AI
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