NCT06466187Leállítva1. fázis
A Study of SGN-MesoC2 in Advanced Solid Tumors
A PHASE 1 OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052666/SGN-MESOC2 IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 7.
Megadott ok: The trial was terminated for strategic reasons. The decision was not based on any safety concerns
Rövid összefoglaló (regiszter, angolul)
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that can't be treated with standard of care drugs. This clinical trial uses an experimental drug called PF-08052666/SGN-MesoC2. PF-08052666/SGN-MesoC2 is a type of antibody-drug conjugate (ADC). ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will have 3 parts. Part A and Part B of the study will find out how much PF-08052666/SGN-MesoC2 should be given to participants. Part C will use the information from Parts A and B to see if PF-08052666/SGN-MesoC2 is safe and if it works to treat solid tumor cancers.
- Állapot (regiszter)
- Leállítva
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 19 (tényleges)
- Első benyújtás
- 2024. jún. 11.
- Kezdés
- 2024. aug. 2.
- Elsődleges befejezés
- 2026. máj. 27.
- Fő szponzor
- Seagen, a wholly owned subsidiary of Pfizer
- Betegségek
- Tüdőrák, Petefészekrák, Hasnyálmirigyrák, Vastagbélrák, Mezotelióma
- NCT-szám
- NCT06466187
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Korábbi kezelés
- Previously received or currently receiving any systemic anticancer therapy or focal radiotherapy within 4 weeks prior to the first dose of MesoC2 or within 2 weeks prior to the first dose of MesoC2 if the underlying disease had progressed on treatment.
- Prior anti-MSLN antibody or MSLN-directed ADC (Part C only).
- Unresolved toxicities from prior therapy greater than NCI CTCAE v5.0 grade 1 at the time of study treatment (except alopecia).
- Previously untreated brain metastases. Participants who received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to study treatment initiation, and there was no evidence of central nervous system progression nor requirements for chronic corticosteroid therapy
Egyéb
- Inadequate hepatic dysfunction, renal function, or hematologic abnormalities.
Kiket keres a vizsgálat
- Aged 18 years or older.
- Histologically- or cytologically-confirmed metastatic or locally advanced unresectable platinum-resistant ovarian cancer, NSCLC, pancreatic ductal adenocarcinoma, endometrial cancer, colorectal cancer, or mesothelioma, who have relapsed or progressed following standard therapies, or for which no standard therapies are available.
- An Eastern Cooperative Oncology Group performance status score of 0 or 1.
- At least 1 measurable lesion at baseline based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- Archival tumor tissue or a fresh tumor biopsy during the screening period.
- Adequate hepatic, renal and bone marrow function.
- Participants must not have received more than 2 lines of cytotoxic systemic therapy in the metastatic setting (Parts B and C only).
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (18)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| McGill University Health Centre | Montreal | Kanada | Ismeretlen állapot |
| University Health Network | Toronto | Kanada | Ismeretlen állapot |
| University Health Network - Princess Margaret Cancer Centre | Toronto | Kanada | Ismeretlen állapot |
| The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham | Birmingham | Egyesült Államok | Ismeretlen állapot |
| University of Alabama at Birmingham | Birmingham | Egyesült Államok | Ismeretlen állapot |
| The University of Alabama at Birmingham | Birmingham | Egyesült Államok | Ismeretlen állapot |
| The University of Kansas - Clinical Research Center | Fairway | Egyesült Államok | Ismeretlen állapot |
| The University of Kansas Hospital | Kansas City | Egyesült Államok | Ismeretlen állapot |
| The University of Kansas Medical Center Medical Office Building | Kansas City | Egyesült Államok | Ismeretlen állapot |
| The University of Kansas Hospital Cambridge North Tower A | Kansas City | Egyesült Államok | Ismeretlen állapot |
| Sarah Cannon Research Institute- Pharmacy | Nashville | Egyesült Államok | Ismeretlen állapot |
| SCRI Oncology Partners | Nashville | Egyesült Államok | Ismeretlen állapot |
| The University of Kansas Cancer Center - Indian Creek Campus | Overland Park | Egyesült Államok | Ismeretlen állapot |
| Start San Antonio, LLC | San Antonio | Egyesült Államok | Ismeretlen állapot |
| START Mountain Region, LLC | West Valley City | Egyesült Államok | Ismeretlen állapot |
| The University of Kansas Cancer Center - Westwood | Westwood | Egyesült Államok | Ismeretlen állapot |
| The University of Kansas Cancer Center - Investigational Drug Services | Westwood | Egyesült Államok | Ismeretlen állapot |
| Atrium Health Wake Forest Baptist | Winston-Salem | Egyesült Államok | Ismeretlen állapot |
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