A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced Solid Tumors and Lymphomas

NCT #
Condition(s)
Lymphoma, Solid Tumor
Molecular Target(s)
ROR1
Drug Classification(s)
Antibody Drug Conjugate, Molecular Targeted Therapy
Agents(s)
CS5001
Phase(s)
I

Mechanism of Action

CS5001 is a highly differentiated Antibody Drug Conjugate targeting ROR1. ROR1 is expressed across a variety of cancers, and may play an important role in oncogenesis by activating cell survival signaling events.

Purpose

In this study, the sponsor and investigators want to learn:
• How much of the study agent can be given with an acceptable level of side effects
• The effects of the study agent (good and bad)
• How much of the study agent is absorbed into the blood and how fast it is removed

Study Design

This is a dose escalation/expansion study. This 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. In the dose expansion part of the study, a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study.

The study treatment will be given in cycles. Each cycle is 21 days. You will receive the study agent every 3 weeks as an infusion directly into a vein (IV) for 60 minutes.

Location

Mary Crowley Cancer Research - Medical City Dallas

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