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 (NCT07278336) — Spain Trial Details

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

ABBV-901: Intravenous (IV)

Bevacizumab: Intravenous (IV)

Carboplatin: Intravenous (IV)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

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 enrolled in backfill (Part 1) must provide consent to paired fresh biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion. For Parts 1-4: \- 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). For Parts 5-6: \- Participants will have platinum-sensitive disease defined as radiographic progression \> 6 months from last dose of platinum-based chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. Exclusion Criteria: * Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, mucinous, carcinosarcoma or sarcomatous histology, mixed tumors or low grade/borderline ovarian tumor. * Participants with platinum refractory disease. * Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor. * Prior history of Grade \>= 2 interstitial lung disease (ILD) or pneumonitis. * Prior history of Grade 2 \>= 2 ILD or pneumonitis or any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan. For Parts 3-6: * History of Grade 3/4 adverse events that, in the opinion of the investigator, are attributed to bevacizumab. * 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. For Parts 5-6: \- Participants who had prior allergic reaction to platinum containing compound.

Primary outcome measure(s)

Number of Participants with Adverse Events (AE) — 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.
Overall Response (as assessed by the investigator) — 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.

Trial sites (26)

Facility	City	Region	Status
City of Hope National Medical Center /ID# 281381	Duarte	California	Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 280914	Irvine	California	Recruiting
Sarah Cannon Research Institute at HealthONE /ID# 278785	Denver	Colorado	Recruiting
University of Chicago Medical Center /ID# 278295	Chicago	Illinois	Recruiting
University Of Nebraska Medical Center /ID# 281020	Omaha	Nebraska	Recruiting
NEXT Oncology - San Antonio /ID# 278606	San Antonio	Texas	Recruiting
Start Mountain Region /ID# 278609	West Valley City	Utah	Recruiting
Next Virginia /ID# 278607	Fairfax	Virginia	Recruiting
Blacktown Hospital /ID# 282426	Blacktown	New South Wales	Recruiting
Monash Health - Monash Medical Centre - Clayton /ID# 281468	Clayton	Victoria	Recruiting
Peter MacCallum Cancer Centre. /ID# 281751	Melbourne	Victoria	Recruiting
Institut De Cancerologie De L'Ouest - Site Rene Gauducheau /ID# 280684	Saint-Herblain	Pays de la Loire Region	Recruiting
Centre Leon Berard /ID# 280575	Lyon	Rhone	Recruiting
The Chaim Sheba Medical Center /ID# 278416	Ramat Gan	Tel Aviv	Recruiting
Rambam Health Care Campus /ID# 278418	Haifa	Israel	Recruiting
Hadassah Medical Center-Hebrew University /ID# 278420	Jerusalem	Israel	Recruiting
National Cancer Center Hospital East /ID# 278604	Kashiwa-shi	Chiba	Recruiting
Saitama Medical University International Medical Center /ID# 278437	Hidaka	Saitama	Recruiting
Shizuoka Cancer Center /ID# 278538	Sunto-gun	Shizuoka	Recruiting
Unidade Local de Saude de Santa Maria /ID# 280296	Lisbon	Portugal	Recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 280293	Porto	Portugal	Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 280459	Majadahonda	Madrid	Recruiting
Hospital Universitario Fundacion Jimenez Diaz /ID# 280440	Madrid	Spain	Recruiting
Hospital Universitario HM Sanchinarro /ID# 280439	Madrid	Spain	Recruiting
National Taiwan University Hospital /ID# 280701	Taipei	Taiwan	Recruiting
Taipei Veterans General Hospital /ID# 281349	Taipei	Taiwan	Recruiting

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