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Clinical Trials in the USA / NCT07878988
Recruiting Phase 1

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

NCT07878988 · tracked via the Priya Life Science USA tracker
Sponsor
LTZ Therapeutics, Inc
Phase
Phase 1
Started
2026-12
Last updated
2026-10-20

Condition(s) studied

Colorectal CancerAdvanced/Metastatic Solid TumorSolid Tumor (Phase I)EPCAMColon Cancer

Investigational drug(s) / intervention(s)

LTZ-232

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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. — 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.

Trial sites (1)

FacilityCityRegionStatus
HonorHealth Research Institute Scottsdale Arizona Recruiting

More LTZ Therapeutics, Inc. trials in the USA

This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma Recruiting

Other trials for the same condition

Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC) Active, not recruiting
A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101) Starting soon
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors Recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07878988 on ClinicalTrials.gov ↗ ← All trials in the USA