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

Study Identifier:
LTZ-232-001
CT.gov Identifier:
NCT07878988
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Dose Escalation in metastatic colorectal cancer
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Drug: 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: Drug: LTZ-232
Drug: LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met.
Drug: EXPERIMENTAL: Dose Expansion in metastatic colorectal cancer and other solid tumor types
Drug: 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: EXPERIMENTAL: Safety/PK/Pharmacodynamic Cohorts
Drug: Participants may be dosed with LTZ-232 intravenously at levels previously declared safe to further explore safety and clinical activity at particular dose levels.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Salwan Al Mutar
Status
Will Be Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Solid Tumor