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| ID | Type | Description | Link |
|---|---|---|---|
| SGNMesoC2-001 | Other Identifier | Alias Study Number |
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The trial was terminated for strategic reasons. The decision was not based on any safety concerns
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-08052666 | Experimental | PF-08052666 monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08052666 | Drug | Given into the vein (IV; intravenously) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 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. | Approximately 1 year 4 months |
| Best response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| The University of Alabama at Birmingham |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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The best timepoint response achieved for the subject during the protocol specified period according to RECIST V1.1. |
| Approximately 1 year 4 months |
| Duration of response (DOR) | 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. | Approximately 1 year 4 months |
| Disease control rate (DCR) | DCR is defined as the proportion of participants with best response of CR, PR or stable disease (SD) according to RECIST v1.1. | Approximately 1 year 4 months |
| Progression-free survival (PFS) | 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. | Approximately 1 year 4 months |
| Overall survival (OS) | Overall survival (OS) defined as the time from first dosing to death. | Approximately 1 year 4 months |
| Pharmacokinetic (PK) parameter - Area under the serum concentration (AUC) | Cycles 1, 2, and 3 (each cycle is up to 21 days) |
| Pharmacokinetic (PK) parameter - Maximum serum concentration (Cmax) | Cycles 1, 2, and 3 (each cycle is up to 21 days) |
| Pharmacokinetic (PK) parameter - Time to reach maximum serum concentration (Tmax) | Cycles 1, 2, and 3 (each cycle is up to 21 days) |
| 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) |
| 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 | 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 |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008654 | Mesothelioma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
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