ACTIVE_NOT_RECRUITING

A Study of SGN-MesoC2 in Advanced Solid Tumors

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Conditions

Carcinoma, Non-Small-Cell LungOvarian NeoplasmsPancreatic AdenocarcinomaColorectal NeoplasmsMesotheliomaOther Solid TumorsEndometrialNSCLLung NeoplasmCancer of OvaryOvarian CancerColorectal CancerColorectal TumorsSeattle Genetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-02
Study Completion:2029-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06466187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 years or older.
  2. * 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.
  3. * An Eastern Cooperative Oncology Group performance status score of 0 or 1.
  4. * At least 1 measurable lesion at baseline based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
  5. * Archival tumor tissue or a fresh tumor biopsy during the screening period.
  6. * Adequate hepatic, renal and bone marrow function.
  7. * Participants must not have received more than 2 lines of cytotoxic systemic therapy in the metastatic setting (Parts B and C only).
  1. * 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.
  2. * Prior anti-MSLN antibody or MSLN-directed ADC (Part C only).
  3. * Unresolved toxicities from prior therapy greater than NCI CTCAE v5.0 grade 1 at the time of study treatment (except alopecia).
  4. * Inadequate hepatic dysfunction, renal function, or hematologic abnormalities.
  5. * 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

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249
United States
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205
United States
The University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, 66160
United States
The University of Kansas Hospital
Kansas City, Kansas, 66160
United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, 66160
United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, 66211
United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
United States
The University of Kansas Cancer Center, Investigational Drug Services
Westwood, Kansas, 66205
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
START San Antonio, LLC
San Antonio, Texas, 78229
United States
START Mountain Region, LLC
Salt Lake City, Utah, 84119
United States
START Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-02
Study Completion Date2029-05-01

Study Record Updates

Study Start Date2024-08-02
Study Completion Date2029-05-01

Terms related to this study

Keywords Provided by Researchers

  • NSCL
  • Lung Neoplasm
  • Cancer of Ovary
  • Ovarian Cancer
  • Colorectal Cancer
  • Colorectal Tumors
  • Endometrial
  • Seattle Genetics

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung
  • Ovarian Neoplasms
  • Pancreatic Adenocarcinoma
  • Colorectal Neoplasms
  • Mesothelioma
  • Other Solid Tumors
  • Endometrial