IMGN151 for Ovarian Cancer

Recruiting at 68 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Ocular disorders, Cardiac disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

423 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IMGN151 (also known as Opugotamig olatansine) for individuals with certain types of recurring cancers, such as ovarian, endometrial, and cervical cancer. The main goal is to assess the safety and tolerability of the treatment and determine its effectiveness in shrinking tumors. Suitable candidates typically have recurring cancer and have not responded to standard treatments. Participants will receive the treatment through an IV every three weeks. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that IMGN151 is likely to be safe for humans?

Research shows that IMGN151, a new drug for ovarian cancer, is in the early stages of testing. As it is in a Phase 1 trial, researchers are studying it in humans for the first time. They are primarily focused on assessing its safety and tolerability.

Currently, there is limited information on how people respond to IMGN151. The main goal at this stage is to determine if it causes any serious side effects. Since this is the first human trial, participant safety is a top priority, and researchers will closely monitor for any issues. If the drug had been used for another condition before, more safety information might be available, but as a new treatment, evidence is still being collected. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ovarian cancer, which often include surgery and chemotherapy, IMGN151 is unique because it targets cancer cells with a new mechanism of action. IMGN151 works as an antibody-drug conjugate, delivering a potent anti-cancer agent directly to the cancer cells, sparing more of the healthy cells in the body. This targeted approach not only has the potential to increase the effectiveness of the treatment but also to reduce the side effects commonly associated with broader chemotherapy. Researchers are excited about IMGN151 because it represents a promising new direction in the fight against ovarian cancer, offering hope for more effective and less toxic treatment options.

What evidence suggests that IMGN151 might be an effective treatment for ovarian cancer?

Research shows that IMGN151 is an antibody-drug conjugate, combining a targeted antibody with a chemotherapy drug. This design aims to deliver chemotherapy directly to cancer cells, potentially protecting healthy cells from damage. Early studies are examining its safety and mechanism in the body, but data on its effectiveness in humans is not yet available. This trial investigates IMGN151's potential to treat ovarian and similar cancers. Its design suggests effectiveness by targeting specific cancer cells while sparing normal tissues. The scientific community eagerly anticipates whether these promising features will translate into real patient benefits. ^{1 5 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to provide a sample of my tumor for testing.

Patients must have completed prior therapy within specified times

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion 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.

Prior known hypersensitivity reactions to study drugs and/or any of their excipients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation and Expansion

Participants receive IMGN151 via intravenous infusion on Day 1 of each 3-week cycle to determine safety, tolerability, and preliminary antitumor activity

Up to 3 years

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• IMGN151

Trial Overview 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.

How Is the Trial Designed?

Group I: IMGN151 Experimental Treatment 1 Intervention

IMGN151 is administered via intravenous (IV) infusion on Day 1 of Cycle 1 every 3-week cycle (Q3W).

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

ImmunoGen, Inc.

Lead Sponsor

Trials

33

Recruited

4,000+

Published Research Related to This Trial

Olaparib maintenance therapy demonstrated good efficacy in patients with high-grade serous ovarian cancer, with 3.84% achieving complete response and 7.69% showing partial response, while also improving quality of life across various domains.

The treatment was generally well-tolerated, with most adverse events being Grade 1 and 2, although 16.32% of patients experienced Grade 3 anemia and 20.40% experienced neutropenia, leading to dose reductions in 73.40% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events and quality of life in high-grade serous ovarian cancer patients with Olaparib maintenance therapy: A single-center study in China. Jiang, Y., Xu, T., Yuan, L., et al.[2023]

The study identified CD151 as a critical cell-surface marker that supports the survival and growth of certain high-grade serous ovarian cancer (HGSC) cell lines, indicating its potential as a therapeutic target.

High expression levels of CD151 are associated with poor clinical outcomes in HGSC patients, suggesting that it could serve as a prognostic marker for disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interrogation of Functional Cell-Surface Markers Identifies CD151 Dependency in High-Grade Serous Ovarian Cancer. Medrano, M., Communal, L., Brown, KR., et al.[2018]

A new human ovarian cancer cell line, YDOV-151, was established from mucinous cystadenocarcinoma, providing a valuable model for studying this type of cancer and its biology.

Microarray analysis identified five candidate biomarkers (SFN, RGC32, LAMP3, CDCA7, and SLCO4A1) that are significantly up-regulated in YDOV-151, with potential roles in cell cycle regulation and metastasis, which could aid in the development of diagnostic tools for ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular characterization of a new ovarian cancer cell line, YDOV-151, established from mucinous cystadenocarcinoma. Cho, H., Lim, BJ., Kang, ES., et al.[2021]

CD151-α3β1 integrin complexes play a crucial role in suppressing the malignancy of serous-type ovarian cancer, as their expression is significantly reduced in 90% of metastatic lesions compared to primary tumors.

Knocking down CD151 or α3 integrin leads to increased tumor cell proliferation and changes associated with epithelial to mesenchymal transition (EMT), indicating that these complexes help regulate tumor growth by inhibiting Slug-mediated EMT and Wnt signaling pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD151-α3β1 integrin complexes suppress ovarian tumor growth by repressing slug-mediated EMT and canonical Wnt signaling. Baldwin, LA., Hoff, JT., Lefringhouse, J., et al.[2018]

Mirvetuximab soravtansine (IMGN853) demonstrated a manageable safety profile in patients with platinum-resistant ovarian cancer, with most adverse events being mild and primarily consisting of diarrhea, blurred vision, nausea, and fatigue.

The treatment showed clinical activity, with a confirmed objective response rate of 26% overall, and a higher response rate of 39% in patients who had received three or fewer prior lines of therapy, indicating potential effectiveness in earlier treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Activity of Mirvetuximab Soravtansine (IMGN853), a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer: A Phase I Expansion Study. Moore, KN., Martin, LP., O'Malley, DM., et al.[2019]

Despite high initial response rates to surgery and platinum-based chemotherapy in ovarian cancer, most patients experience relapse, highlighting the need for new treatment strategies to improve survival.

Recent phase III trials have shown that the anti-angiogenic agent bevacizumab, when used alongside chemotherapy and as maintenance therapy, can positively impact outcomes in first-line ovarian cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal first-line treatment in ovarian cancer. Raja, FA., Chopra, N., Ledermann, JA.[2022]

OGN expression is significantly higher in serous papillary cystadenocarcinoma and endometrioid adenocarcinoma compared to non-tumor tissues, suggesting its role in ovarian carcinoma progression.

Higher levels of OGN are linked to worse overall and progression-free survival in ovarian carcinoma patients, indicating it may serve as a potential prognostic biomarker associated with the epithelial-mesenchymal transition (EMT) process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elevated OGN expression correlates with the EMT signature and poor prognosis in ovarian carcinoma. Chen, H., Yang, L., Sun, W.[2020]

Mirvetuximab soravtansine is a promising antibody-drug conjugate that targets folate receptor-α, showing favorable tolerability and encouraging efficacy, particularly in patients with platinum-resistant ovarian cancer.

Ongoing Phase III and Phase Ib/II trials are currently assessing its effectiveness as a monotherapy and in combination treatments, which will clarify its potential role in treating advanced ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer. Moore, KN., Martin, LP., O'Malley, DM., et al.[2019]

GDF15 is highly expressed in many ovarian cancer tissues and its over-expression promotes cancer cell growth and invasion, suggesting it plays a significant role in ovarian cancer progression.

Inhibiting the mTOR pathway may be an effective treatment strategy for ovarian cancers that over-express GDF15, as blocking this pathway reduced the growth and invasion of cancer cells stimulated by GDF15.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth differentiation factor 15 stimulates rapamycin-sensitive ovarian cancer cell growth and invasion. Griner, SE., Joshi, JP., Nahta, R.[2021]

LRRC15 is significantly overexpressed in ovarian cancer metastases compared to primary tumors and promotes metastasis by inhibiting cell death and enhancing adhesion and invasion through omental-like matrices.

Targeting LRRC15 with the antibody-drug conjugate ABBV-085 effectively prevents metastatic spread in preclinical models, indicating a promising new therapeutic approach for treating ovarian cancer metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting LRRC15 Inhibits Metastatic Dissemination of Ovarian Cancer. Ray, U., Jung, DB., Jin, L., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05527184

NCT05527184 | First in Human Study of IMGN151 in ... A Phase 1, first in human, open-label dose-escalation, optimization, and expansion study designed to characterize the safety, tolerability, pharmacokinetics ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07024784

NCT07024784 | A Study to Assess Change in Disease ... The purpose of this study is to assess safety and tolerability of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies in adult ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-imgn151-for-women-with-recurrent-endometrial-and-ovarian-cancer/

Study on the Safety and Effectiveness of IMGN151 ... This study investigates the safety and efficacy of the antibody-drug conjugate, IMGN151, in treating recurrent endometrial cancer and ...

4. healthscout.app healthscout.app/trial_match/view_trial/NCT05527184/?back=/trial_match/view_trials/condition/cervical/%3Fpage%3D24

Trial: First in Human Study of IMGN151 in Recu… - HealthScout Efficacy. No human efficacy outcomes ... Participants with ovarian cancer with histologies including clear cell, mucinous, or borderline ovarian ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=3ac40090-afca-4912-8604-770d56fee527

opugotamig olatansine (IMGN-151) / AbbVie IMGN-151 is a next-generation FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications.

6. adcreview.com adcreview.com/drugmap/imgn151/

Opugotamig olatansine | IMGN-151 | IMGN151 IMGN151 is a next-generation anti-FRα ADC designed to address tumors with a broad range of FRα-expression (e.g., ovarian, endometrial, triple-negative ...

7. news.abbvie.com news.abbvie.com/2020-05-15-ImmunoGen-to-Present-Preclinical-Data-on-IMGN151-at-AACR-Virtual-Annual-Meeting

ImmunoGen to Present Preclinical Data on IMGN151 at ... IMGN151 is a next-generation ADC, designed to address the unmet needs of cancer patients with tumor types expressing lower levels of folate receptor alpha (FRα ...

8. withpower.com withpower.com/trial/phase-1-fallopian-tube-neoplasms-8-2022-c415a

IMGN151 for Ovarian Cancer 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 ...