Overview
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.
Description
LTZ-232 is an engineered anti-EPCAM bispecific antibody designed to activate tumor-associated macrophages to phagocytose and kill tumor cells.
Eligibility
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 breast feeding
- Non-colorectal active malignancy within 3 years that could interfere with study interpretation
