Recruiting
Phase 1

LTZ-232

Sponsor:

LTZ Therapeutics, Inc.

Code:

NCT07878988

Conditions

Colorectal Cancer

Advanced/Metastatic Solid Tumor

Solid Tumor (Phase I)

EPCAM

Colon Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LTZ-232

Study Details

Brief 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.

Conditions

Colorectal Cancer

Advanced/Metastatic Solid Tumor

Solid Tumor (Phase I)

EPCAM

Colon Cancer

Study ID

NCT07878988

Start date

Dec, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

152 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

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.

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.

experimental: Dose Expansion

Participants with unresectable or metastatic colorectal cancer and other specific solid tumor types at a LTZ-232 dosing regimen(s) identified from dose escalation.

Interventions

LTZ-232

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

Primary outcome measure

  • Safety and Tolerability [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Sherry Unabia

669-207-0084sherry.unabia@ltztherapeutics.com

Locations

HonorHealth Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Stephanie Stanford

480-323-1350stsanford@honorhealth.com

Principal Investigator:

Sunil Sharma, MD

More Information

Sponsor

LTZ Therapeutics, Inc.

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by LTZ Therapeutics, Inc. on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.