IV ABBV901 alone and with bevacizumab for platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer
A Phase 1 First-in-Human, Open-Label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-901 as a Monotherapy and in Combination With Bevacizumab in Adult Subjects With Ovarian Cancer
This will test IV ABBV901, alone and together with bevacizumab, in adults with platinum-resistant high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer to see if it is safe and helps control disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 207 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | bevacizumab |
| Locations | 8 sites (San Antonio, Texas and 7 other locations) |
| Trial ID | NCT07278336 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with histologically confirmed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are platinum-resistant (radiographic progression within ~6 months of last platinum) and have had no more than five prior lines of therapy are the intended candidates.
Not a fit: Patients with platinum-sensitive disease, non-high-grade serous histology, more than five prior therapy lines, or who cannot tolerate phase 1 procedures (frequent visits, IV infusions, or biopsies) are unlikely to match or benefit from this trial.
Why it matters
Potential benefit: If successful, ABBV901—alone or with bevacizumab—could provide a new treatment option that slows disease progression for people with platinum-resistant high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
How similar studies have performed: Bevacizumab is an approved agent in ovarian cancer and combinations of bevacizumab with novel agents have shown mixed results, but ABBV901 is investigational and its safety and efficacy in this setting remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 must be considered platinum resistant. 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). * Prior anticancer therapy: * Must have received appropriate standard of care therapy and be appropriate for participation in a Phase I study in the opinion of the investigator. * Platinum-resistant, high grade serous EOC cannot have had more than 5 prior lines of therapy, with clinical progression of disease on no more than 2 prior therapies since the development of platinum resistance. * For participants enrolled in backfill, subjects must provide consent to paired biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion. Exclusion Criteria: * Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, clear cell, mucinous, or borderline ovarian tumor. * Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor. * Prior history of Grade \>= 2 ILD or pneumonitis. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan. * Must not have systemically used known strong cytochrome P450 (CYP)3A inhibitors or inducers within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of the study drug through the end of the DLT observation period. If clinically indicated, strong CYP3A inhibitors and inducers may be used with caution after the dose-limiting toxicity (DLT) period.
Where this trial is running
San Antonio, Texas and 7 other locations
- NEXT Oncology - San Antonio /ID# 278606 — San Antonio, Texas, United States (Recruiting)
- Start Mountain Region /ID# 278609 — West Valley City, Utah, United States (Recruiting)
- Next Virginia /ID# 278607 — Fairfax, Virginia, United States (Recruiting)
- The Chaim Sheba Medical Center /ID# 278416 — Ramat Gan, Tel Aviv, Israel (Recruiting)
- Rambam Health Care Campus /ID# 278418 — Haifa, Israel (Recruiting)
- Hadassah Medical Center-Hebrew University /ID# 278420 — Jerusalem, Israel (Recruiting)
- Saitama Medical University International Medical Center /ID# 278437 — Hidaka, Saitama, Japan (Recruiting)
- Shizuoka Cancer Center /ID# 278538 — Sunto-gun, Shizuoka, Japan (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.