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

October 30, 2026 updated by: LTZ Therapeutics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

LTZ-232 is an engineered anti-EPCAM bispecific antibody designed to activate tumor-associated macrophages to phagocytose and kill tumor cells.

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • HonorHealth Research Institute
        • Principal Investigator:
          • Sunil Sharma, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation in metastatic colorectal cancer

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

LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met.
Experimental: Safety/PK/Pharmacodynamic Cohorts

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

LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met.
Experimental: Dose Expansion in metastatic colorectal cancer and other solid tumor types

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Up to 24 months

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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LTZ Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2026

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

October 11, 2026

First Submitted That Met QC Criteria

October 11, 2026

First Posted (Actual)

October 16, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

October 30, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTZ-232-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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