LTZ Therapeutics, Inc.
This is a first-in-human, Phase 1, multi-center, open-label study to characterize the safety, pharmacokinetics, pharmacodynamics, and preliminary anti tumor activity of LTZ-232 as monotherapy in adult participants with unresectable or metastatic colorectal cancer and other solid tumors failing standard therapies.
LTZ-232 is an engineered anti-EPCAM bispecific antibody designed to activate tumor-associated macrophages to phagocytose and kill tumor cells.
Inclusion Criteria: * Advanced /metastatic colorectal tumors that have failed standard treatments * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) * Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 * Adequate organ function based on laboratory testing Exclusion Criteria: * Active infection with hepatitis B or C * Uncontrolled CNS metastases * Active autoimmune disease * Clinically significant cardiovascular disease not adequately controlled with medication or impaired function * Previous treatment with EpCAM targeting agent * Pregnant or…
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met.
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