NCT07278336Toboroz1. fázis
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
A Phase 1 First-in-Human, Open-Label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-901 as a Monotherapy and in Combination in Adult Subjects With Ovarian Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 13.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 285 (tervezett)
- Első benyújtás
- 2025. dec. 2.
- Kezdés
- 2025. nov. 27.
- Elsődleges befejezés
- 2028. dec.
- Fő szponzor
- AbbVie
- Betegségek
- Petefészekrák
- NCT-szám
- NCT07278336
- EU CT-szám
- 2025-522209-40-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 285
- 2025. nov. 27. és az elsődleges befejezés (2028. dec.) között
- 29 helyszín, 9 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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 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).
- Participants who had prior allergic reaction to platinum containing compound.
Más betegség
- 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.
- History of Grade 3/4 adverse events that, in the opinion of the investigator, are attributed to bevacizumab.
Laborértékek
- 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:
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (29)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Blacktown Hospital /ID# 282426 | Blacktown | Ausztrália | Toboroz |
| Monash Health - Monash Medical Centre - Clayton /ID# 281468 | Clayton | Ausztrália | Toboroz |
| Peter MacCallum Cancer Centre. /ID# 281751 | Melbourne | Ausztrália | Toboroz |
| Rigshospitalet | Copenhagen Oe | Dánia | Toborzás még nem indult |
| Hospital Universitari Vall d'Hebron | Barcelona | Spanyolország | Toboroz |
| Hospital Universitario HM Sanchinarro | Madrid | Spanyolország | Toboroz |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spanyolország | Toboroz |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Spanyolország | Toboroz |
| Centre Leon Berard | Lyon | Franciaország | Toboroz |
| Institut De Cancerologie De L Ouest | Saint-Herblain Cedex | Franciaország | Toboroz |
| Institut Gustave Roussy | Villejuif | Franciaország | Toboroz |
| Rambam Health Care Campus /ID# 278418 | Haifa | Izrael | Toboroz |
| Hadassah Medical Center-Hebrew University /ID# 278420 | Jerusalem | Izrael | Toboroz |
| The Chaim Sheba Medical Center /ID# 278416 | Ramat Gan | Izrael | Toboroz |
| Saitama Medical University International Medical Center /ID# 278437 | Hidaka | Japán | Toboroz |
| National Cancer Center Hospital East /ID# 278604 | Kashiwa-shi | Japán | Toboroz |
| Shizuoka Cancer Center /ID# 278538 | Sunto-gun | Japán | Toboroz |
| Unidade Local De Saude De Santa Maria E.P.E. | Lisbon | Portugália | Toboroz |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. | Porto | Portugália | Toboroz |
| National Taiwan University Hospital /ID# 280701 | Taipei | Tajvan | Toboroz |
| Taipei Veterans General Hospital /ID# 281349 | Taipei | Tajvan | Toboroz |
| University of Chicago Medical Center /ID# 278295 | Chicago | Egyesült Államok | Toboroz |
| Sarah Cannon Research Institute at HealthONE /ID# 278785 | Denver | Egyesült Államok | Toboroz |
| City of Hope National Medical Center /ID# 281381 | Duarte | Egyesült Államok | Toboroz |
| Next Virginia /ID# 278607 | Fairfax | Egyesült Államok | Toboroz |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 280914 | Irvine | Egyesült Államok | Toboroz |
| University Of Nebraska Medical Center /ID# 281020 | Omaha | Egyesült Államok | Toboroz |
| NEXT Oncology - San Antonio /ID# 278606 | San Antonio | Egyesült Államok | Toboroz |
| Start Mountain Region /ID# 278609 | West Valley City | Egyesült Államok | Toboroz |
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