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.
Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.
Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC).
The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A.
Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.
Previous exposure to CEACAM5-targeted therapy.
Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).
History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
Active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral/meningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs).
Sequential
PF-08046050
DrugGiven into the vein (IV; intravenous)
bevacizumab
DrugGiven into the vein (IV; intravenous)
5-Fluorouracil (5-FU)
DrugGiven into the vein (IV; intravenous)
Oxaliplatin
DrugGiven into the vein (IV; intravenous)
Leucovorin (LV)
DrugGiven into the vein (IV; intravenous)
6
Treatment groupsSee each treatment group below.
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
Number of participants with laboratory abnormalities
Number of dose modifications due to AEs
Number of participants with dose-limiting toxicities (DLTs)
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
PK endpoint
PK parameter - Maximum concentration (Cmax)
PK endpoint
PK parameter - Time to maximum concentration (Tmax)
PK endpoint
PK parameter - Trough concentration (Ctrough)
PK endpoint
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Seagen, a wholly owned subsidiary of Pfizer
Lead sponsor
Sanofi
Collaborator
