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RECRUITING Phase 1 ClinicalTrials.gov

This is a Phase 1/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors

Sponsor: LTZ Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07878988

Registry updated: 2026-10-20
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Description

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.

Interventions

  • LTZ-232 (Drug)
    LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met.

Eligibility criteria

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

Conditions

Colorectal Cancer Advanced/Metastatic Solid Tumor Solid Tumor (Phase I) EPCAM Colon Cancer

Locations

  • HonorHealth Research Institute — Scottsdale, Arizona, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record