What side effects are associated with this type of intervention?

Antibody-Drug Conjugates (ADCs) like IMGN151, which target cancer cells, often have side effects that include fatigue, nausea, peripheral neuropathy, and hematologic toxicities such as neutropenia and thrombocytopenia. Other common treatments for ovarian cancer, such as chemotherapy agents like carboplatin and paclitaxel, can cause side effects including hair loss, gastrointestinal issues (nausea, vomiting, diarrhea), and increased risk of infection due to lowered white blood cell counts. Targeted therapies, such as PARP inhibitors, may lead to anemia, fatigue, and gastrointestinal disturbances. Participation in clinical trials may also present unique side effects specific to the investigational drug being studied.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer, including targeted therapies and Antibody-Drug Conjugates (ADCs). One notable ADC is Tisotumab vedotin-tftv, approved for recurrent or metastatic cervical cancer, which shares similarities with ovarian cancer treatments. Additionally, Bevacizumab, a monoclonal antibody targeting VEGF, has been approved for use in combination with chemotherapy for ovarian cancer. Other targeted therapies include PARP inhibitors like Olaparib, Niraparib, and Rucaparib, which are used for maintenance therapy in patients with recurrent, platinum-sensitive ovarian cancer. These treatments represent significant advancements in targeting cancer cells more precisely, similar to the approach being studied with IMGN151.

What other types of research exist?

Promising novel alternatives to IMGN151 for ovarian cancer patients include Mirvetuximab soravtansine, an ADC targeting folate receptor-alpha, and Tisotumab vedotin, an ADC targeting tissue factor. Both have shown efficacy in clinical trials for ovarian cancer. Additionally, novel therapies such as PARP inhibitors (e.g., Olaparib, Niraparib) and immune checkpoint inhibitors (e.g., Pembrolizumab) continue to be promising options.

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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

No Placebo-Only Group

Summary

This trial is testing IMGN151, a new drug, in adults with certain recurrent cancers to see if it is safe, how the body handles it, if it causes immune reactions, and if it can help fight the cancer.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Characterize Safety (Escalation)

Define Recommended Phase 2 Dose (Escalation)

Determine Objective Response Rate (Expansion)

Secondary study objectives

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 more

Other study objectives

Determine Progression Free Survival (Escalation)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian cancer include surgery, chemotherapy, targeted therapy, and immunotherapy. Surgery aims to remove as much of the tumor as possible. Chemotherapy, often platinum-based, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, such as PARP inhibitors, interfere with specific molecules involved in cancer cell growth and survival. Immunotherapy, including checkpoint inhibitors, helps the immune system recognize and attack cancer cells. Antibody-Drug Conjugates (ADCs) like IMGN151 combine an antibody specific to cancer cells with a cytotoxic drug, delivering the drug directly to the cancer cells while sparing normal cells. This targeted approach can reduce side effects and improve efficacy, which is crucial for ovarian cancer patients who often face significant toxicity from traditional chemotherapy.