IV ABBV901 alone and with bevacizumab for platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study will enroll about 207 adults at multiple sites worldwide to study the safety, how the body processes ABBV901 (pharmacokinetics), and early signs of activity. The trial has four parts: dose escalation of ABBV901 alone, dose optimization of ABBV901 alone, dose escalation of ABBV901 combined with IV bevacizumab, and an expansion phase of the recommended combination dose. Participants will receive intravenous ABBV901 either alone or with standard-dose bevacizumab and will be monitored for adverse events, disease activity, and drug levels in blood. The design uses standard phase 1 escalation and expansion cohorts to identify tolerable doses and gather preliminary efficacy and biomarker data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of an advanced or unresectable malignant high grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC), fallopian tube or primary peritoneal cancer by histology (World Health Organization \[WHO\] criteria).
* Participants enrolled in backfill (Part 1) must provide consent to paired fresh biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion.

For Parts 1-4:

\- Participants must be considered platinum resistant or platinum ineligible. Platinum resistant disease is defined as radiographic progression within 6 months (up to 182 days) after the last dose of the most recent platinum therapy).

For Parts 5-6:

\- Participants will have platinum-sensitive disease defined as radiographic progression \> 6 months from last dose of platinum-based chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.

Exclusion Criteria:

* Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, mucinous, carcinosarcoma or sarcomatous histology, mixed tumors or low grade/borderline ovarian tumor.
* Participants with platinum refractory disease.
* Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor.
* Prior history of Grade \>= 2 interstitial lung disease (ILD) or pneumonitis.
* Prior history of Grade 2 \>= 2 ILD or pneumonitis or any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan.

For Parts 3-6:

* History of Grade 3/4 adverse events that, in the opinion of the investigator, are attributed to bevacizumab.
* History of clinically significant cardiac disease including CHF Class II or higher NYHA; active coronary artery disease, MI within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted).
* Echocardiogram with ejection fraction \<= 50% and no other clinically significant cardiac abnormalities that in the opinion of the investigator, would increase the participants susceptibility to cardiac toxicity.

For Parts 5-6:

\- Participants who had prior allergic reaction to platinum containing compound.

Where it's running

• City of Hope National Medical Center /ID# 281381
  Duarte, California, United States Recruiting
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 280914
  Irvine, California, United States Recruiting
• Sarah Cannon Research Institute at HealthONE /ID# 278785
  Denver, Colorado, United States Recruiting
• University of Chicago Medical Center /ID# 278295
  Chicago, Illinois, United States Recruiting
• University Of Nebraska Medical Center /ID# 281020
  Omaha, Nebraska, United States Recruiting
• NEXT Oncology - San Antonio /ID# 278606
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.