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. Participants in this study must have cancer that has come back or did not get better with treatment. Participants 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-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body. This study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
914
Given into the vein (IV; intravenous)
Given into the vein (IV; intravenous)
Given into the vein (IV; intravenous)
Given into the vein (IV; intravenous)
Given into the vein (IV; intravenous)
Mayo Clinic Hospital
Phoenix, Arizona, United States
RECRUITINGMayo Clinic
Scottsdale, Arizona, United States
RECRUITINGCity of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
RECRUITINGIP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, United States
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
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with laboratory abnormalities
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
Number of dose modifications due to AEs
Time frame: Through end of treatment up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
Number of participants with DLTs by dose level
Time frame: Up to 28 days
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
PK endpoint
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Maximum concentration (Cmax)
PK endpoint
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax)
PK endpoint
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Trough concentration (Ctrough)
PK endpoint
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with antidrug antibodies (ADAs)
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
Objective response rate (ORR)
The objective response rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation in Solid Tumors (RECIST) v1.1.
Time frame: Through end of study and up to approximately 2 years
Best overall response
The best overall response for a participant will be determined by the order of confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), not evaluable (NE) or not applicable (NA) per RECIST v1.1.
Time frame: Through end of study and up to approximately 2 years
Duration of response (DOR)
DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST v1.1 or to death due to any cause
Time frame: Through end of study and up to approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from start of SGN-CEACAM5C to first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause, whichever comes first
Time frame: Through end of study and up to approximately 2 years
Overall survival (OS)
OS is defined as the time from start of SGN-CEACAM5C to date of death due to any cause
Time frame: Through end of study and up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States
RECRUITINGUniversity of Colorado Hospital/University of Colorado
Aurora, Colorado, United States
RECRUITINGUniversity of Colorado Hospital
Aurora, Colorado, United States
RECRUITINGFlorida Cancer Specialists
Orlando, Florida, United States
RECRUITINGSarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
RECRUITINGSchool of Medicine
Baltimore, Maryland, United States
RECRUITING...and 34 more locations