First-in-Human Study of LAT010 for Patients with Advanced Solid Tumors (LIGHTSPEED-1)

Sponsor: Latticon Antibody Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06277219

Provider View

This clinical trial is testing a new drug, LAT010, to see if it is safe and effective for treating advanced solid tumors. The study is divided into two parts: the first part focuses on finding the right dose, and the second part evaluates how well the drug works in different types of cancer.

Patient Parameters

Program Overview

This study is testing a new treatment called LAT010 for patients with advanced solid tumors. The trial is in two phases: Phase 1 aims to find a safe dose, and Phase 2 will test the drug's effectiveness in specific cancers. LAT010 is designed to activate certain immune cells to fight cancer without causing severe side effects. Participants will receive the drug through an IV once a week for four weeks in each treatment cycle. The study will help determine if LAT010 can safely and effectively treat advanced cancers.

Description

LAT010 is a new treatment designed to help the immune system fight cancer by targeting specific immune cells. Unlike other treatments, it aims to avoid severe side effects by focusing on certain receptors. The study is divided into two phases:

  • Phase 1: This phase will test different doses of LAT010 to find the safest and most effective amount. About 20 to 50 patients with advanced solid tumors will participate. They will receive LAT010 once a week for four weeks, and researchers will monitor them for any side effects.

  • Phase 2: After determining the best dose in Phase 1, this phase will involve more patients to see how well LAT010 works against specific types of cancer. Up to 30 patients per cancer type will be enrolled to further evaluate the treatment's safety and effectiveness.

The study aims to provide a new treatment option for patients with advanced cancers who have limited options. Participants will undergo regular health checks and tests to monitor their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced solid tumors that have not responded to standard treatments or have no other treatment options.
  • Have at least one measurable tumor.
  • Be in good overall health with a life expectancy of more than 12 weeks.
  • Have not received IL-2 therapy in the past year.
  • Meet specific blood and organ function requirements.
  • Agree to use effective birth control during the study and for 90 days after the last dose.
  • For Phase 2, must be willing to provide tumor samples for research purposes.

Exclusion Criteria

  • Have had recent heart problems, such as a heart attack or stroke, within the past 6 months.
  • Are currently participating in another clinical trial.
  • Have active cancer in the brain that has not been treated.
  • Have another active cancer that has not been treated.
  • Have severe side effects from previous treatments.
  • Have active infections or serious medical conditions.
  • Are pregnant or breastfeeding.
  • Have a history of severe allergies to the study drug.
  • Are unable to follow the study requirements.

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