An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors

Seagen, a wholly owned subsidiary of Pfizer

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. 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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Tumor type: * 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 tu…

Interventions

Drug
PF-08046050
Given into the vein (IV; intravenous)
Drug
bevacizumab
Given into the vein (IV; intravenous)
Drug
5-Fluorouracil (5-FU)
Given into the vein (IV; intravenous)
Drug
Oxaliplatin
Given into the vein (IV; intravenous)
Drug
Leucovorin (LV)
Given into the vein (IV; intravenous)

Locations (44)

Mayo Clinic Hospital
Phoenix, Arizona
Mayo Clinic
Scottsdale, Arizona
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado
University of Colorado Hospital
Aurora, Colorado