A Phase 1 interventional study of LTZ-232 in Colorectal Cancer, Advanced/Metastatic Solid Tumor and Solid Tumor (Phase I), sponsored by LTZ Therapeutics, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by LTZ Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 152 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →LTZ Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Participants in this arm will participate in one (1) of up to eight (8) escalating defined dose level cohorts. Participants may receive LTZ-232 intravenously up to 24 months unless treatment discontinuation criteria are met.
Drug: LTZ-232
Participants may be dosed with LTZ-232 intravenously at levels previously declared safe to further explore safety and clinical activity at particular dose levels.
Drug: LTZ-232
Participants with unresectable or metastatic colorectal cancer and other specific solid tumor types at a LTZ-232 dosing regimen(s) identified from dose escalation.
Drug: LTZ-232
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met.
Characterize the Safety and Tolerability of LTZ-232 in metastatic colorectal cancer and other solid tumors using the incidence, severity, and type of adverse events according to CTCAE v5.0.
To determine the incidence, severity, and type of adverse events according to NCI and CTCAE v5.0 and assessment of protocol defined dose limiting toxicity criteria.
Time frame: Up to 24 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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LTZ Therapeutics, Inc.