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 bevacizumab, in participants with ovarian cancer. ABBV901 is an investigational drug for the treatment of ovarian cancer. This study has 4 Parts (Arms) where participants will receive ABBV-901, alone or in combination with the standard available therapy, bevacizumab. Around 219 participants will be enrolled in the study at approximately 75 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, combination with IV bevacizumab. In part 4, participants will receive recommended doses for expansion of IV ABBV-901, combination with 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
219
Intravenous (IV)
IV
Sarah Cannon Research Institute at HealthONE /ID# 278785
Denver, Colorado, United States
RECRUITINGUniversity of Chicago Medical Center /ID# 278295
Chicago, Illinois, United States
RECRUITINGNEXT Oncology - San Antonio /ID# 278606
San Antonio, Texas, United States
RECRUITINGStart Mountain Region /ID# 278609
West Valley City, Utah, United States
RECRUITINGNext Virginia /ID# 278607
Fairfax, Virginia, United States
RECRUITINGSun Yat-Sen University Cancer Center /ID# 282505
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGQilu Hospital Of Shandong University /ID# 283564
Jinan, Shandong, China
NOT_YET_RECRUITINGShandong Cancer Hospital /ID# 283566
Jinan, Shandong, China
NOT_YET_RECRUITINGFudan University Shanghai Cancer Center /ID# 282600
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGThe Chaim Sheba Medical Center /ID# 278416
Ramat Gan, Tel Aviv, Israel
RECRUITING...and 7 more locations
Number of Participants with Adverse Events (AE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 3 Years
Overall Response
Overall response is defined as participants achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by the investigator.
Time frame: Up to Approximately 3 Years
Duration of Response (DOR)
DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST Version 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
Time frame: Up to Approximately 3 Years
Progression-free survival (PFS)
PFS is defined as time from first study treatment to a documented disease progression according to RECIST Version 1.1 (or other assessment criteria), as determined by the investigator, or death due to any cause, whichever occurs earlier.
Time frame: Up to Approximately 3 Years
Overall Survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Time frame: Up to Approximately 3 Years
Disease Control Rate
Disease Control Rate is defined as the percentage of participants with best overall response (BOR) of stable disease (SD), PR or better per investigator review according to RECIST version 1.1 criteria.
Time frame: Up to Approximately 3 Years
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