A Study of SGN-MesoC2 in Advanced Solid Tumors

NCT ID: NCT06466187

Last Updated: 2025-11-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-02

Study Completion Date

2029-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-08052666

PF-08052666 monotherapy

Group Type EXPERIMENTAL

PF-08052666

Intervention Type DRUG

Given into the vein (IV; intravenously)

Interventions

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PF-08052666

Given into the vein (IV; intravenously)

Intervention Type DRUG

Other Intervention Names

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HBM9033; SGN-MesoC2

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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).
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seagen, a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Mayo Clinic

Scottsdale, Arizona, United States

Site Status RECRUITING

Mayo Clinic Pharmacy

Jacksonville, Florida, United States

Site Status RECRUITING

The University of Kansas Clinical Research Center

Fairway, Kansas, United States

Site Status RECRUITING

The University of Kansas Hospital Cambridge North Tower A

Kansas City, Kansas, United States

Site Status RECRUITING

The University of Kansas Hospital

Kansas City, Kansas, United States

Site Status RECRUITING

The University of Kansas Medical Center Medical Office Building

Kansas City, Kansas, United States

Site Status RECRUITING

The University of Kansas Medical Center Research Institute, Inc

Kansas City, Kansas, United States

Site Status RECRUITING

The University of Kansas Cancer Center - Indian Creek Campus

Overland Park, Kansas, United States

Site Status RECRUITING

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, United States

Site Status RECRUITING

The University of Kansas Cancer Center, Investigational Drug Services

Westwood, Kansas, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Atrium Health Wake Forest Baptist, Department of Pharmacy, Investigational Drug Service

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status RECRUITING

James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

Site Status RECRUITING

Ohio State University Hospital

Columbus, Ohio, United States

Site Status RECRUITING

OSU Brain and Spine Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Martha Morehouse Tower

Columbus, Ohio, United States

Site Status RECRUITING

Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run

Hilliard, Ohio, United States

Site Status RECRUITING

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee, United States

Site Status RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

START San Antonio, LLC

San Antonio, Texas, United States

Site Status RECRUITING

START Mountain Region

West Valley City, Utah, United States

Site Status RECRUITING

University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

The Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Seagen Pfizer CT.gov Call Center

Role: CONTACT

Phone: 1-800-718-1021

Email: [email protected]

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C5991001

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