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Accepting PatientsPhase 1 (Safety)NCT07878988

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

Colorectal Cancer, Advanced/Metastatic Solid Tumor

Phase:Phase 1 (Safety)
Status:Accepting Patients
Age:18+
Gender:All
Locations:1 site

What This Study Is About

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.

Who Can Participate

You May Qualify If
  • Advanced /metastatic colorectal tumors that have failed standard treatments
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  • Adequate organ function based on laboratory testing
You Cannot Join If
  • Previous treatment with EpCAM targeting agent
  • Pregnant or breast feeding
  • Non-colorectal active malignancy within 3 years that could interfere with study interpretation
Discuss With Your Doctor
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1
  • 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
View Full Eligibility Criteria
Full Criteria (from ClinicalTrials.gov)

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

Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.

Study Locations

HonorHealth Research Institute — Scottsdale, Arizona

Contact

Contact

Sherry Unabia

Experimental Treatment

This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.

Apply to This Trial

Your information will be sent to the study coordinator for review.