NCT06131840

A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 914 (estimated)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Stomach Neoplasms
• Pancreatic Ductal Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-11-20
• Primary completion: 2029-09-12
• Completion: 2030-09-12
• First posted: 2023-11-14
• Last updated: 2026-04-07

Locations

43 sites across 7 countries: United States, Canada, France, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study