A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SGN-MesoC2 in Subjects With Advanced Solid Tumors

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Alabama
The University of Alabama at Birmingham
RECRUITING
Birmingham
University of Alabama at Birmingham
RECRUITING
Birmingham
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Mayo Clinic Hospital
RECRUITING
Phoenix
Mayo Clinic
RECRUITING
Scottsdale
Florida
Mayo Clinic Pharmacy
RECRUITING
Jacksonville
Kansas
The University of Kansas Clinical Research Center
RECRUITING
Fairway
The University of Kansas Hospital
RECRUITING
Kansas City
The University of Kansas Hospital Cambridge North Tower A
RECRUITING
Kansas City
The University of Kansas Medical Center Medical Office Building
RECRUITING
Kansas City
The University of Kansas Medical Center Research Institute, Inc
RECRUITING
Kansas City
The University of Kansas Cancer Center - Indian Creek Campus
RECRUITING
Overland Park
The University of Kansas Cancer Center - Westwood
RECRUITING
Westwood
The University of Kansas Cancer Center, Investigational Drug Services
RECRUITING
Westwood
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
Atrium Health Wake Forest Baptist, Department of Pharmacy, Investigational Drug Service
RECRUITING
Winston-salem
Ohio
James Cancer Hospital and Solove Research Institute
RECRUITING
Columbus
Martha Morehouse Tower
RECRUITING
Columbus
Ohio State University Hospital
RECRUITING
Columbus
OSU Brain and Spine Hospital
RECRUITING
Columbus
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
RECRUITING
Hilliard
Tennessee
Sarah Cannon Research Institute - Pharmacy
RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
Texas
START San Antonio, LLC
RECRUITING
San Antonio
Utah
START Mountain Region
RECRUITING
West Valley City
Other Locations
Canada
McGill University Health Centre
RECRUITING
Montreal
The Research Institute of the McGill University Health Centre
RECRUITING
Montreal
University Health Network
RECRUITING
Toronto
University Health Network, Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Seagen Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-08-02
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 365
Treatments
Experimental: PF-08052666
PF-08052666 monotherapy
Sponsors
Leads: Seagen, a wholly owned subsidiary of Pfizer

This content was sourced from clinicaltrials.gov

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