NCT04590326Toboroz1/2. fázis
A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 24.
Rövid összefoglaló (regiszter, angolul)
This study is researching an investigational drug called REGN5668 : * alone or, * combined with cemiplimab (also known as REGN2810) or, * combined with both cemiplimab and fianlimab (also known as REGN3767), or * combined with ubamatamab (also known as REGN4018), with or without sarilumab. The main purposes of this study are to: * Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus * Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2. The study is looking at several other research questions, including: * Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood * To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 612 (tervezett)
- Első benyújtás
- 2020. okt. 9.
- Kezdés
- 2020. dec. 8.
- Elsődleges befejezés
- 2028. nov. 8.
- Fő szponzor
- Regeneron Pharmaceuticals
- Betegségek
- Petefészekrák, Méhtestrák
- NCT-szám
- NCT04590326
- EU CT-szám
- 2022-501904-83-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 612
- 2020. dec. 8. és az elsődleges befejezés (2028. nov. 8.) között
- 28 helyszín, 5 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy
- Prior treatment with a Mucin 16 (MUC16)-targeted therapy
- Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy
- Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug
- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
Más betegség
- Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol
- Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
- Has history of clinically significant cardiovascular disease as defined in the protocol
- Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).
- Note: Other protocol-defined Inclusion/Exclusion criteria apply
Kiket keres a vizsgálat
- Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol
- Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.
- Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)
- Has adequate organ and bone marrow function as defined in the protocol
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of at least 3 months
- Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol
Életkor a regiszterben: 18 év – - · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (28)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| UZ Leuven | Leuven | Belgium | Toboroz |
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | Brazília | Toboroz |
| Centro de Pesquisa em Oncologia PUCRS | Porto Alegre | Brazília | Toboroz |
| AC Camargo Cancer Center, Fundacao Antonio Prudente | São Paulo | Brazília | Toboroz |
| Unimed Sorocaba | Sorocaba | Brazília | Toboroz |
| Institut Català d'Oncologia | Girona | Spanyolország | Toboroz |
| Hospital Clínico San Carlos | Madrid | Spanyolország | Toboroz |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spanyolország | Toboroz |
| Hospital Universitario 12 de Octubre | Madrid | Spanyolország | Toboroz |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spanyolország | Toboroz |
| Institut Bergonie | Bordeaux | Franciaország | Toboroz |
| Centre Francois Baclesse | Caen Cedex 5 | Franciaország | Toboroz |
| Centr Georges Francois Leclerc | Dijon | Franciaország | Toboroz |
| Hospices Civils de Lyon | Pierre-Bénite | Franciaország | Toboroz |
| Institut Gustave Roussy | Villejuif | Franciaország | Toboroz |
| Massachusetts General Hospital | Boston | Egyesült Államok | Toboroz |
| Dana Farber Cancer Institute Brookline Avenue | Boston | Egyesült Államok | Toboroz |
| University of Chicago Medical Center | Chicago | Egyesült Államok | Toboroz |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Egyesült Államok | Toboroz |
| The Ohio State University -Wexner Medical Center | Columbus | Egyesült Államok | Toboroz |
| Karmanos Cancer Institute | Detroit | Egyesült Államok | Toboroz |
| City of Hope Comprehensive Cancer Center | Duarte | Egyesült Államok | Toboroz |
| The City of Hope Orange County Lennar Foundation Cancer Center | Irvine | Egyesült Államok | Toboroz |
| Memorial Sloan-Kettering Cancer Center | New York | Egyesült Államok | Toboroz |
| Chao Family Comprehensive Cancer Center | Orange | Egyesült Államok | Toboroz |
| Perelman School of Medicine at the University of Pennsylvania | Philadelphia | Egyesült Államok | Toboroz |
| Seattle Cancer Care Alliance at South Lake Union - G3630 | Seattle | Egyesült Államok | Toboroz |
| H Lee Moffitt Cancer Center | Tampa | Egyesült Államok | Befejeződött |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.