A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors

LCB84 is an anti-TROP2 ADC

In this study, the sponsor and investigators want to learn:

• How much of the study agent can be given alone or in combination with Pembrolizumab with an acceptable level of side effects
• The effects of the study agent alone or in combination with Pembrolizumab (good and bad)
• How much of the study agent is absorbed into the blood and how fast it is removed
• If research tests can be used in the future to predict who will benefit from LCB84
• How the study agent is acting on your body

Dose Escalation (Phase 1) means that the amount of the study agent given will be increased in each group of research participants, to find the most appropriate dose for further study.  Phase 1 will also include “Enrichment” cohorts, also known as backfill, where additional participants will be enrolled to previously cleared dose levels.

In the dose expansion part of the study (Phase 2), a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study.

The dose of the study agent you receive will be determined by the time you enter the study. Some research participants on both parts of this study will also be receiving Pembrolizumab in combination with the study agent. This will also depend on when you enter the study. Your study doctor will let you know what regimen you will receive on the study.

The study agent will be given in cycles.  Each cycle is 3 weeks long.  You will receive the study agent once a cycle via a 60-minute IV infusion into a vein.