OncoMatch/Clinical Trials/NCT07278336
A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Other Anticancer Drugs in Adult Participants With Ovarian Cancer
Official title: A Phase 1 First-in-Human, Open-Label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-901 as a Monotherapy and in Combination in Adult Subjects With Ovarian Cancer
Is NCT07278336 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including ABBV-901 and Bevacizumab for ovarian cancer.
Treatment: ABBV-901 · Bevacizumab · Carboplatin — Ovarian cancer (OC) is a lethal disease. The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABBV901, alone or in combination with other anticancer drugs, in participants with ovarian cancer. ABBV901 is an investigational drug for the treatment of ovarian cancer. This study has 6 parts where participants will receive ABBV-901, alone or in combination with other anticancer therapies. Around 285 participants will be enrolled in the study at approximately 45 sites around the world. In part 1, participants will receive escalating doses of intravenous (IV) ABBV-901 alone. In part 2, participants will receive 1 of 3 doses of IV ABBV-901 alone to determine the optimized dose. In part 3, participants will receive escalating doses of IV ABBV-901 in combination with IV bevacizumab. In part 4, participants will receive recommended doses for expansion of IV ABBV-901 combination with IV bevacizumab. in Part 5, participants will receive escalating doses of IV ABBV-901 in combination with IV carboplatin and IV bevacizumab and in part 6, participants will receive recommended doses for expansion of IV ABBV-901 combination with IV carboplatin and IV bevacizumab. The total study duration will be approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Ovarian Cancer
Prior therapy
Cannot have received: antibody-drug conjugate containing a topoisomerase inhibitor
Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor.
Lab requirements
Cardiac function
No 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.
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center /ID# 281381 · Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 280914 · Irvine, California
- Sarah Cannon Research Institute at HealthONE /ID# 278785 · Denver, Colorado
- University of Chicago Medical Center /ID# 278295 · Chicago, Illinois
- University Of Nebraska Medical Center /ID# 281020 · Omaha, Nebraska
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07278336 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate containing a topoisomerase inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages