ABBV-901 + Bevacizumab for Ovarian Cancer

Recruiting at 4 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Strong CYP3A inhibitors, inducers

Disqualifiers: Non-serous OC, ILD, pneumonitis, others

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

Compensation: Varies

Number of Visits: Unknown

207 Participants Needed

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.

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

Must have received appropriate standard of care therapy and be appropriate for participation in a Phase I study in the opinion of the investigator

My cancer worsened within 6 months after my last platinum-based treatment.

I agree to have two biopsies taken from the same tumor before and during treatment.

Exclusion Criteria

I haven't taken strong CYP3A affecting drugs in the last 14 days or 5 half-lives before starting the study drug.

My ovarian cancer is not high grade serous but another type.

I have been treated with a specific drug that combines an antibody with chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive escalating doses of intravenous (IV) ABBV-901 alone

Approximately 9 months

Regular visits at a hospital or clinic

Treatment Part 2

Participants receive 1 of 3 doses of IV ABBV-901 alone to determine the optimized dose

Approximately 9 months

Regular visits at a hospital or clinic

Treatment Part 3

Participants receive escalating doses of IV ABBV-901 in combination with IV bevacizumab

Approximately 9 months

Regular visits at a hospital or clinic

Treatment Part 4

Participants receive recommended doses for expansion of IV ABBV-901 in combination with IV bevacizumab

Approximately 9 months

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

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?

Group I: Part 4: ABBV-901 + Bevacizumab Expansion Experimental Treatment 2 Interventions

Participants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.

Group II: Part 3: ABBV-901 + Bevacizumab Escalation Experimental Treatment 2 Interventions

Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.

Group III: Part 2: ABBV-901 Optimization/Expansion Dose C Experimental Treatment 1 Intervention

Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration.

Group IV: Part 2: ABBV-901 Optimization/Expansion Dose B Experimental Treatment 1 Intervention

Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration.

Group V: Part 2: ABBV-901 Optimization/Expansion Dose A Experimental Treatment 1 Intervention

Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration.

Group VI: Part 1: ABBV-901 Dose Escalation Experimental Treatment 1 Intervention

Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07278336

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-Myeloma

ImmunoGen, 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10788010/

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 ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/abbvie-ovarian-cancer-trial/

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 ...

6. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/ovarian-cancer

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, ...