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RecruitingPhase 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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests LTZ-232 alone in people for the first time to check its safety and whether it may fight cancer. It is for adults with colon or rectal cancer or other solid tumors that cannot be removed by surgery or have spread, and for whom standard treatments have failed.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have advanced colon or rectal cancer, or cancer that has spread, after standard treatments have failed.
  • Have cancer that can be measured using standard study rules.
  • Be able to do daily activities with little or no limit on physical activity.
  • Have lab tests showing that organs are working well enough.

Who can't join

  • Have an active hepatitis B or C infection, which affects the liver.
  • Have cancer that has spread to the brain or spinal cord and is not controlled.
  • Have an active autoimmune disease, where the immune system attacks the body.
  • Have serious heart or blood vessel disease that is not well controlled with medicine, or have poor heart function.
  • Have received a treatment targeting EpCAM, a protein on some cells.
  • Are pregnant or breastfeeding.
  • Have had an active cancer other than colon or rectal cancer within the past 3 years that could make study results hard to judge.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

AZ