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 SGN-MesoC2 in Subjects With Advanced Solid Tumors
2 other identifiers
interventional
19
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2024
Longer than P75 for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2024
CompletedFirst Posted
Study publicly available on registry
June 20, 2024
CompletedStudy Start
First participant enrolled
August 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
January 12, 2026
January 1, 2026
3.7 years
June 11, 2024
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Through 30-37 days after the last dose of study treatment, 48 Months
Number of participants with laboratory abnormalities
Through 30-37 days after the last dose of study treatment, 48 Months
Number of participants with dose modifications
Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions and treatment discontinuations) due to AEs
Up to 4 months
Number of participants with dose-limiting toxicities (DLTs)
Incidence of dose-limiting toxicities (DLTs)
Cycle 1 (21 days)
Secondary Outcomes (11)
Objective response rate (ORR)
Approximately 1 year 4 months
Best response
Approximately 1 year 4 months
Duration of response (DOR)
Approximately 1 year 4 months
Disease control rate (DCR)
Approximately 1 year 4 months
Progression-free survival (PFS)
Approximately 1 year 4 months
- +6 more secondary outcomes
Study Arms (1)
PF-08052666
EXPERIMENTALPF-08052666 monotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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
University Health Network
Toronto, Ontario, M5G 2C4, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H3H 2R9, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2024
First Posted
June 20, 2024
Study Start
August 2, 2024
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2029
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.