ABBV-901 + Bevacizumab for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, ABBV-901, for ovarian cancer. It tests the drug alone and with bevacizumab, a standard therapy, to assess safety and effectiveness. The trial is divided into parts to determine the best dose and combination. It targets individuals with advanced ovarian cancer that has not responded well to platinum-based chemotherapy. Participants should have experienced disease progression despite previous treatments and must attend frequent visits for assessments and tests. 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 requires that you stop using strong CYP3A inhibitors or inducers (types of drugs that affect how your body processes other medications) at least 14 days before starting the study drug. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that ABBV-901, the new drug being tested for ovarian cancer, is still under evaluation for safety. Previous patients demonstrated that ABBV-901 was manageable at different doses. However, as this is an early-phase study, detailed safety information remains limited.
When combined with bevacizumab, studies have found that bevacizumab, a common treatment for various cancers, is usually well-tolerated. In ovarian cancer patients, bevacizumab has shown some benefits, but like all treatments, it may have side effects.
Overall, because this trial is in its early stages, it primarily aims to find a safe dose and understand how the treatment works. Participants might experience side effects, and the study will closely monitor these.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ABBV-901 for treating ovarian cancer because it works differently from current standard treatments like chemotherapy and targeted therapy. Most treatments focus on killing rapidly dividing cells, but ABBV-901 is an antibody-drug conjugate designed to deliver a chemotherapy agent directly to cancer cells, minimizing damage to healthy cells. Additionally, the combination of ABBV-901 with Bevacizumab, a medication that inhibits blood vessel growth in tumors, offers a dual approach by both targeting cancer cells and reducing the tumor’s blood supply, potentially enhancing treatment effectiveness. This innovative mechanism could lead to better outcomes with fewer side effects for patients.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
This trial will evaluate ABBV-901 both alone and with Bevacizumab for treating ovarian cancer. Studies have shown promising results for ABBV-901, with over 60% of patients in earlier trials responding well; 39% showed a very good partial response, and 23% had a partial response. In this trial, some participants will receive ABBV-901 alone, while others will receive it with Bevacizumab. Previous studies combining ABBV-901 with Bevacizumab showed that 79% of patients experienced tumor shrinkage, a significant improvement over other treatments. Bevacizumab is known to enhance chemotherapy by improving blood flow to tumors, making them more responsive to treatment. These findings suggest that ABBV-901, especially when used with Bevacizumab, holds promise for effectively managing ovarian cancer.12346
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This trial is for adults with ovarian cancer. Participants will be involved in a study lasting about 3 years, receiving either ABBV901 alone or combined with bevacizumab. They'll need to visit the hospital or clinic regularly for medical assessments, blood tests, and scans.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive escalating doses of intravenous (IV) ABBV-901 alone
Treatment Part 2
Participants receive 1 of 3 doses of IV ABBV-901 alone to determine the optimized dose
Treatment Part 3
Participants receive escalating doses of IV ABBV-901 in combination with IV bevacizumab
Treatment Part 4
Participants receive recommended doses for expansion of IV ABBV-901 in combination with IV bevacizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV901
- Bevacizumab
Trial Overview
The study is testing ABBV901's safety and effectiveness both as a standalone treatment and paired with bevacizumab against ovarian cancer. It involves four parts: escalating doses of ABBV-901 alone, dose optimization of ABBV-901 alone, escalating doses of ABBV-901 with bevacizumab, and recommended doses of the combination therapy.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Participants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration.
Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration.
Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration.
Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
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
Citations
A Study to Assess Adverse Events, Change in Disease ...
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABBV901, alone or in combination with bevacizumab, in ...
2.
news.abbvie.com
news.abbvie.com/2011-06-05-ImmunoGen,-Inc-Announces-Positive-Clinical-Data-Presented-on-IMGN901-in-the-Treatment-of-Multiple-MyelomaImmunoGen, Inc. Announces Positive Clinical Data ...
Over 60% (8/13) had an objective response to treatment: 39% had a very good partial response (VGPR), and 23% had a partial response (PR). VGPR ...
Efficacy and safety of VEGF/VEGFR inhibitors for platinum- ...
The meta-analysis demonstrated that combination therapy with VEGF/VEGFR inhibitors yielded better clinical outcomes for patients with PROC compared to ...
AbbVie reports positive Phase II ovarian cancer trial data
In the trial, treatment with mirvetuximab soravtansine offered a 51.9% objective response rate in ovarian cancer patients.
5.
investingnews.com
investingnews.com/health-canada-approves-elahere-r-for-certain-types-of-platinum-resistant-ovarian-cancers/Health Canada Approves ELAHERE® for Certain Types of ...
Health Canada has approved ELAHERE ® the first novel therapy to demonstrate statistically significant and clinically meaningful improvements ...
Ovarian Cancer Clinical Trials - Mayo Clinic Research
This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, ...
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