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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
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

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (18)

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HelyszínVárosOrszágHelyszín állapota
McGill University Health CentreMontrealKanadaIsmeretlen állapot
University Health NetworkTorontoKanadaIsmeretlen állapot
University Health Network - Princess Margaret Cancer CentreTorontoKanadaIsmeretlen állapot
The Board of Trustees of the University of Alabama for the University of Alabama at BirminghamBirminghamEgyesült ÁllamokIsmeretlen állapot
University of Alabama at BirminghamBirminghamEgyesült ÁllamokIsmeretlen állapot
The University of Alabama at BirminghamBirminghamEgyesült ÁllamokIsmeretlen állapot
The University of Kansas - Clinical Research CenterFairwayEgyesült ÁllamokIsmeretlen állapot
The University of Kansas HospitalKansas CityEgyesült ÁllamokIsmeretlen állapot
The University of Kansas Medical Center Medical Office BuildingKansas CityEgyesült ÁllamokIsmeretlen állapot
The University of Kansas Hospital Cambridge North Tower AKansas CityEgyesült ÁllamokIsmeretlen állapot
Sarah Cannon Research Institute- PharmacyNashvilleEgyesült ÁllamokIsmeretlen állapot
SCRI Oncology PartnersNashvilleEgyesült ÁllamokIsmeretlen állapot
The University of Kansas Cancer Center - Indian Creek CampusOverland ParkEgyesült ÁllamokIsmeretlen állapot
Start San Antonio, LLCSan AntonioEgyesült ÁllamokIsmeretlen állapot
START Mountain Region, LLCWest Valley CityEgyesült ÁllamokIsmeretlen állapot
The University of Kansas Cancer Center - WestwoodWestwoodEgyesült ÁllamokIsmeretlen állapot
The University of Kansas Cancer Center - Investigational Drug ServicesWestwoodEgyesült ÁllamokIsmeretlen állapot
Atrium Health Wake Forest BaptistWinston-SalemEgyesült ÁllamokIsmeretlen állapot

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