Clinical trial NCT06466187: A Study of SGN-MesoC2 in Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Pancreatic Adenocarcinoma
Colorectal Neoplasms
Mesothelioma
Other Solid Tumors
Endometrial
Keywords: NSCL
Lung Neoplasm
Cancer of Ovary
Ovarian Cancer
Colorectal Cancer
Colorectal Tumors
Endometrial
Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-20
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Through 30-37 days after the last dose of study treatment, 48 Months
measure: Number of participants with laboratory abnormalities
timeFrame: Through 30-37 days after the last dose of study treatment, 48 Months
measure: Number of participants with dose modifications
timeFrame: Up to 4 months
measure: Number of participants with dose-limiting toxicities (DLTs)
timeFrame: Cycle 1 (21 days)
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Approximately 1 year 4 months
measure: Best response
timeFrame: Approximately 1 year 4 months
measure: Duration of response (DOR)
timeFrame: Approximately 1 year 4 months
measure: Disease control rate (DCR)
timeFrame: Approximately 1 year 4 months
measure: Progression-free survival (PFS)
timeFrame: Approximately 1 year 4 months
measure: Overall survival (OS)
timeFrame: Approximately 1 year 4 months
measure: Pharmacokinetic (PK) parameter - Area under the serum concentration (AUC)
timeFrame: Cycles 1, 2, and 3 (each cycle is up to 21 days)
measure: Pharmacokinetic (PK) parameter - Maximum serum concentration (Cmax)
timeFrame: Cycles 1, 2, and 3 (each cycle is up to 21 days)
measure: Pharmacokinetic (PK) parameter - Time to reach maximum serum concentration (Tmax)
timeFrame: Cycles 1, 2, and 3 (each cycle is up to 21 days)
measure: Pharmacokinetic (PK) parameter - Half-life
timeFrame: Cycles 1, 2, and 3 (each cycle is up to 21 days)
measure: Number of participants with antidrug antibodies
timeFrame: Cycles 1, 2, and 3 (each cycle is up to 21 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fairway
country: United States
facility: The University of Kansas Clinical Research Center
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Hospital Cambridge North Tower A
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Medical Center Medical Office Building
state: Kansas
city: Overland Park
country: United States
facility: The University of Kansas Cancer Center - Indian Creek Campus
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center - Westwood
state: Kansas
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Columbus
country: United States
facility: James Cancer Hospital and Solove Research Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Hospital
state: Ohio
city: Columbus
country: United States
facility: OSU Brain and Spine Hospital
state: Ohio
city: Columbus
country: United States
facility: Martha Morehouse Tower
state: Ohio
city: Hilliard
country: United States
facility: Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
state: Ohio
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: