LTZ-232: a first-in-human test in advanced colorectal and other solid tumors
Official title: 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
Run by LTZ Therapeutics, Inc. · NCT07878988 · Data updated 2026-11-12
A first-in-human study tests LTZ-232, a new therapy for adults with unresectable or metastatic colorectal cancer and other solid tumors that have not responded to standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 152 (estimated) |
| Sponsor | LTZ Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Scottsdale, Arizona) |
| Status | Recruiting |
| Started | October 28, 2026 |
| Main results expected | December 2031 |
| Study ends | December 2031 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07878988 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced or metastatic colorectal cancer or other solid tumors that have progressed after standard therapies, with measurable disease and ECOG 0–1.
✕Probably not a fit
Patients with active infections, uncontrolled CNS metastases, autoimmune disease, significant cardiovascular disease, prior EpCAM-targeted therapy, pregnancy or lactation, or recent other malignancies may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1/1b, open-label, multi-center trial to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LTZ-232 when given alone. LTZ-232 is an engineered anti-EPCAM bispecific antibody designed to activate tumor-associated macrophages to help kill tumor cells. The study enrolls adults with advanced colorectal cancer or other solid tumors and requires measurable disease and good performance status. Participants will receive LTZ-232 and undergo safety monitoring and laboratory assessments to characterize its initial clinical profile. Prior EpCAM-targeted therapies are exclusionary to avoid confounding effects.
Why it matters
Potential benefit: If successful, LTZ-232 could provide preliminary tumor control and valuable safety data that may guide further development.
How similar studies have gone: Prior anti-EPCAM approaches have shown signals in early studies, but this first-in-human bispecific antibody represents a novel approach with early safety and activity signals yet to be established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
HonorHealth Research Institute
Scottsdale, Arizona, United States Recruiting
Study contacts
- Study coordinator: Sherry Unabia
- Email: sherry.unabia@ltztherapeutics.com
- Phone: 669-207-0084
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.