IMGN151 for Ovarian Cancer

Recruiting at 24 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AbbVie

Disqualifiers: Ocular disorders, Cardiac disease, Stroke, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug IMGN151 for ovarian cancer?

The drug mirvetuximab soravtansine, which is similar to IMGN151, showed promising results in treating platinum-resistant ovarian cancer, with a 26% response rate and manageable side effects. This suggests that IMGN151, which may have similar properties, could also be effective. ^{1 2 3 4 5}

What makes the drug IMGN151 unique for treating ovarian cancer?

IMGN151 is unique because it is an antibody-drug conjugate, which means it combines an antibody with a chemotherapy drug to specifically target and kill cancer cells, potentially reducing side effects compared to traditional chemotherapy. ^{6 7 8 9 10}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

I am 18 years old or older.

Patients must have completed prior therapy within specified times

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

Trial Timeline

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

Treatment Details

Interventions

• IMGN151 (Monoclonal Antibodies)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Targeting LRRC15 Inhibits Metastatic Dissemination of Ovarian Cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Optimal first-line treatment in ovarian cancer. [2022]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

CD151-α3β1 integrin complexes suppress ovarian tumor growth by repressing slug-mediated EMT and canonical Wnt signaling. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Growth differentiation factor 15 stimulates rapamycin-sensitive ovarian cancer cell growth and invasion. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Interrogation of Functional Cell-Surface Markers Identifies CD151 Dependency in High-Grade Serous Ovarian Cancer. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Elevated OGN expression correlates with the EMT signature and poor prognosis in ovarian carcinoma. [2020]

10. Japan pubmed.ncbi.nlm.nih.gov

Molecular characterization of a new ovarian cancer cell line, YDOV-151, established from mucinous cystadenocarcinoma. [2021]