ABBV-901
DrugIntravenous (IV)
NCT Number: NCT07278336
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Sun Yat-Sen University Cancer Center /ID# 282505, Guangzhou, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous (IV)
IV
Time frame: Up to Approximately 3 Years
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 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
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
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
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 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.
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07059845
Adnexal Diseases, Endocrine Gland Neoplasms
La Jolla, California, United States
View Trial DetailsNCT04657068
Acinar Cell Carcinoma, Adenocarcinoma
Birmingham, Alabama, United States
View Trial DetailsNCT03877796
Adnexal Diseases, Endocrine Gland Neoplasms
Tampa, Florida, United States
View Trial DetailsNCT07736937
Adnexal Diseases, Endocrine Gland Neoplasms
Brussels, Belgium
View Trial Details