A Study of SGN-MesoC2 in Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Pancreatic Adenocarcinoma; Colorectal Neoplasms; Mesothelioma; Other Solid Tumors; Endometrial
• Interventions: Drug: PF-08052666

• Registration Number: NCT06466187
• Lead Sponsor: Seagen, a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-20
• Study Start: 2024-08-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-02-17
• Study Completion: 2029-02-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 365

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PF-08052666	PF-08052666	PF-08052666 monotherapy

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Through 30-37 days after the last dose of study treatment, 48 Months	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.
Number of participants with dose modifications	Up to 4 months	Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions and treatment discontinuations) due to AEs
Number of participants with laboratory abnormalities	Through 30-37 days after the last dose of study treatment, 48 Months
Number of participants with dose-limiting toxicities (DLTs)	Cycle 1 (21 days)	Incidence of dose-limiting toxicities (DLTs)

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	Approximately 1 year 4 months	DCR is defined as the proportion of participants with best response of CR, PR or stable disease (SD) according to RECIST v1.1.
Pharmacokinetic (PK) parameter - Area under the serum concentration (AUC)	Cycles 1, 2, and 3 (each cycle is up to 21 days)
Objective response rate (ORR)	Approximately 1 year 4 months	ORR is defined as the proportion of participants in the relevant analysis set with best response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Best response	Approximately 1 year 4 months	The best timepoint response achieved for the subject during the protocol specified period according to RECIST V1.1.
Overall survival (OS)	Approximately 1 year 4 months	Overall survival (OS) defined as the time from first dosing to death.
Pharmacokinetic (PK) parameter - Maximum serum concentration (Cmax)	Cycles 1, 2, and 3 (each cycle is up to 21 days)
Duration of response (DOR)	Approximately 1 year 4 months	DOR is defined as the time interval from first occurrence of documented objective response to the time of progressive disease (PD) according to RECIST v1.1 or death from any cause, whichever comes first.
Pharmacokinetic (PK) parameter - Time to reach maximum serum concentration (Tmax)	Cycles 1, 2, and 3 (each cycle is up to 21 days)
Progression-free survival (PFS)	Approximately 1 year 4 months	PFS is defined as the time from first dosing to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first.
Pharmacokinetic (PK) parameter - Half-life	Cycles 1, 2, and 3 (each cycle is up to 21 days)
Number of participants with antidrug antibodies	Cycles 1, 2, and 3 (each cycle is up to 21 days)

Trial Locations

Locations (18)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, 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 Cancer Center - Indian Creek Campus; 🇺🇸 Overland Park, Kansas, United States

The University of Kansas Cancer Center - Westwood; 🇺🇸 Westwood, Kansas, 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

SCRI Oncology Partners; 🇺🇸 Nashville, Tennessee, United States

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

START Mountain Region; 🇺🇸 West Valley City, Utah, United States

University Health Network, Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada