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New treatment option for Ovarian Cancer
Official title A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Bevacizumab in Adult Participants With Ovarian Cancer
ClinicalTrials.gov ID: NCT07278336
What this study is testing
What is ABBV-901?
ABBV-901 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of an advanced or unresectable malignant high grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC)...
- Participants must be considered platinum resistant or platinum ineligible. Platinum resistant disease is defined as radiographic progression within 6...
- 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 2 prior lines of therapy, since the development of platinum resistance or...
You likely can't join if
- Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, clear cell, mucinous, or borderline ovarian...
- 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, or any evidence of active ILD or...
- 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...
See the full eligibility 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...
- 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...
- 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 2 prior lines of therapy, since the development of platinum resistance or ineligibility.
- For participants enrolled in backfill, people must provide consent to paired biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion.
- 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, or 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 study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Chicago, Illinois, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Guangzhou, Guangdong, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Ramat Gan, Tel Aviv, Israel
- Haifa, Israel
- Jerusalem, Israel
- Kashiwa-shi, Chiba, Japan
- Hidaka, Saitama, Japan
- Sunto-gun, Shizuoka, Japan
- Christchurch, Canterbury, New Zealand
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Chicago, Illinois, United States; San Antonio, Texas, United States; West Valley City, Utah, United States; Fairfax, Virginia, United States; Guangzhou, Guangdong, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.