Ovarian Cancer
Conditions
Interventions
Part 1: ABBV-901 Dose Escalation
Part 2: ABBV-901 Optimization/Expansion Dose A, Dose B, Dose C
Part 3: ABBV-901 + Bevacizumab Escalation
Part 4: ABBV-901 + Bevacizumab Expansion
Sponsors
Tsutsui Atsuko
Eligibility
Sex/Gender
Female
Inclusion 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 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). - Prior anticancer therapy: 1. Must have received appropriate standard of care therapy and be appropriate for participation in a Phase I study in the opinion of the investigator. 2. Platinum-resistant, high grade serous EOC cannot have had more than 2 prior lines of therapy since the development of platinum resistance or ineligibility. - 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
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. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Number of Participants with Adverse Events (AE) - Overall Response | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of Response (DOR) - Progression-free survival (PFS) - Overall Survival (OS) - Disease Control Rate | — |
Countries
Israel, Japan, United States of America
Contacts
Public ContactContact for Patients and HCP
AbbVie GK
Outcome results
None listed