152 Participants NeededMy employer runs this trial

LTZ-232 for Colorectal Cancer

SU
Overseen BySherry Unabia
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: LTZ Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LTZ-232, to determine its safety and effectiveness for individuals with advanced colorectal cancer and other solid tumors unresponsive to standard treatments. The study will examine the drug's behavior in the body and any early indications of tumor reduction. Participants will be divided into groups receiving varying doses to identify the safest and most effective levels. This trial may suit those with colorectal cancer that cannot be surgically removed or has metastasized, and for whom previous treatments have failed. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LTZ-232 is likely to be safe for humans?

In this study, LTZ-232 undergoes testing in humans for the first time. As this research is in its early stages, limited information exists about its safety in people. The primary goal is to determine LTZ-232's safety and understand its effects in the body. Participants receive doses deemed safe in earlier tests. Although researchers exercise caution, unknown risks may still exist. If the drug receives approval later, it will have undergone further testing to ensure safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for colorectal cancer, like chemotherapy and targeted therapy, LTZ-232 brings a fresh approach by targeting a new mechanism. Researchers are excited about LTZ-232 because it works by targeting specific pathways involved in cancer cell growth and survival, which might lead to better outcomes for patients with metastatic colorectal cancer. This investigational drug is administered intravenously and offers the potential for personalized dosing, which could enhance its effectiveness and reduce side effects compared to traditional treatments.

What evidence suggests that LTZ-232 might be an effective treatment for colorectal cancer?

Research has shown that LTZ-232 is a promising new treatment for colorectal cancer. Participants in this trial will receive LTZ-232, a unique antibody that attaches to two different targets, aiding the immune system in fighting cancer cells. This treatment activates certain cells around the tumor, potentially improving patient outcomes. Early studies suggest LTZ-232 could be effective by targeting specific proteins in colorectal cancer cells. Although still in early stages, its mechanism indicates potential benefits for those whose cancer did not respond to standard treatments.678910

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic colorectal cancer or other solid tumors that cannot be removed by surgery and have not responded to standard treatments.

Inclusion Criteria

My organ function tests are within the normal range.
I have tumors that can be measured by scans or exams.
I am fully active or restricted in physically strenuous activity only.
See 1 more

Exclusion Criteria

Pregnant or breast feeding
I have heart disease that is not well controlled or affects my daily activities.
I have been treated with a medicine that targets EpCAM.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants in this arm will participate in one of up to eight escalating defined dose level cohorts. Participants may receive LTZ-232 intravenously.

Up to 24 months

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.

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LTZ-232

Trial Overview

The study is testing a new drug called LTZ-232, given alone, to see if it is safe and shows early signs of working against these cancers. It’s an open-label Phase 1 trial where all participants receive the drug.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Safety/PK/Pharmacodynamic CohortsExperimental Treatment1 Intervention
Group II: Dose Expansion in metastatic colorectal cancer and other solid tumor typesExperimental Treatment1 Intervention
Group III: Dose Escalation in metastatic colorectal cancerExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

LTZ Therapeutics, Inc.

Lead Sponsor

Citations

LTZ Therapeutics Announces FDA Clearance of IND ...

LTZ's clinical development strategy for LTZ-232 initially prioritizes colorectal cancer supported by disease biology and internal data ...

LTZ Therapeutics Wins FDA IND Clearance for LTZ-232, a ...

LTZ Therapeutics has received FDA IND clearance for LTZ-232, a first-in-class bispecific antibody designed to activate tumor-associated ...

NCT07878988 | This is a Phase 1/1b Study to Evaluate the ...

This is a Phase 1/​1b Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/​Metastatic ...

New Therapies for Metastatic Colorectal Cancer - PMC - NIH

Although patient outcomes are improving, the 5-year survival rate is only 65% for all patients diagnosed with CRC, and a mere 14% of patients with advanced or ...

LTZ-232 - This is a Phase 1/1b Study to Evaluate the Safety ...

This is a first-in-human, Phase 1, multi-center, open-label study to characterize the safety, pharmacokinetics, pharmacodynamics, ...

Cancer

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Cancer

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What Is Cancer? - NCI

Explanations about what cancer is, how cancer cells differ from normal cells, and genetic changes that cause cancer to grow and spread.

Cancers | Open Access Journal

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10.

en.wikipedia.org

en.wikipedia.org/wiki/Cancer

Cancer

Cancer is a group of diseases involving uncontrolled cell growth typically resulting in tumors with the potential to invade or spread to other parts of the ...