Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
365 participants
INTERVENTIONAL
2024-08-02
2029-05-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PF-08052666
PF-08052666 monotherapy
PF-08052666
Given into the vein (IV; intravenously)
Interventions
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PF-08052666
Given into the vein (IV; intravenously)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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).
* Inadequate hepatic dysfunction, renal function, or hematologic abnormalities.
* 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
18 Years
ALL
No
Sponsors
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Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
The University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Mayo Clinic Pharmacy
Jacksonville, Florida, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
The University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, United States
The University of Kansas Medical Center Research Institute, Inc
Kansas City, Kansas, United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
The University of Kansas Cancer Center, Investigational Drug Services
Westwood, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Atrium Health Wake Forest Baptist, Department of Pharmacy, Investigational Drug Service
Winston-Salem, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
OSU Brain and Spine Hospital
Columbus, Ohio, United States
Martha Morehouse Tower
Columbus, Ohio, United States
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Hilliard, Ohio, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
START San Antonio, LLC
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
University Health Network
Toronto, Ontario, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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SGNMesoC2-001
Identifier Type: OTHER
Identifier Source: secondary_id
C5991001
Identifier Type: -
Identifier Source: org_study_id