LTZ-232 for Colorectal Cancer
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants may be dosed with LTZ-232 intravenously at levels previously declared safe to further explore safety and clinical activity at particular dose levels.
Participants with unresectable or metastatic colorectal cancer and other specific solid tumor types at a LTZ-232 dosing regimen(s) identified from 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.
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 ...
2.
biopharminternational.com
biopharminternational.com/view/ltz-therapeutics-wins-fda-ind-clearance-for-ltz-232-a-myeloid-engager-bispecific-targeting-epcam-positive-colorectal-cancerLTZ 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 ...
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07878988?aggFilters=status%3A%2CfunderType%3AindustryNCT07878988 | 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, ...
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