Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Endometrial, Mesothelioma, Other Solid Tumors, Ovarian Neoplasms, Pancreatic Adenocarcinoma
Conditions
Keywords
NSCL, Lung Neoplasm, Cancer of Ovary, Ovarian Cancer, Colorectal Cancer, Colorectal Tumors, Endometrial, Seattle Genetics
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.
Interventions
DRUGPF-08052666
Given into the vein (IV; intravenously)
Sponsors
Seagen, a wholly owned subsidiary of Pfizer
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 laboratory abnormalities | Through 30-37 days after the last dose of study treatment, 48 Months | — |
| 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 dose-limiting toxicities (DLTs) | Cycle 1 (21 days) | Incidence of dose-limiting toxicities (DLTs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Overall survival (OS) | Approximately 1 year 4 months | Overall survival (OS) defined as the time from first dosing to death. |
| 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) | — |
Countries
Canada, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed