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NCT05941507 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumors, sponsored by LigaChem Biosciences.

Recruiting
Registry status
Phase 1
Development phase
300
Enrollment target
8
Study locations

NCT05941507 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by LigaChem Biosciences. The registered enrollment target is 300 participants, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (52% higher). The trial reports 8 study locations across 6 states.

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The verdict

NCT05941507, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by LigaChem Biosciences.

RECRUITING
Registry status
Phase 1
Development phase
300 participants
Enrollment target
8
Study locations

Study Summary

This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a minimum of 2 dose levels of single agent LCB84 have established DLT safety, to determine the MTD and/or RP2D of combination LCB84 and anti-PD-1 Ab, and to continue into dose expansion cohorts in select tumor types.

Conditions Studied

Advanced Solid Tumors

Interventions

  • DRUG Anti-PD-1 monoclonal antibody
  • DRUG LCB84

Study Locations (8)

Texas

  • Mary Crowley Cancer Research - Dallas
  • University of Texas Southwestern Medical Center - Dallas
  • MD Anderson Cancer Center - Houston

California

  • Cedars Sinai Medical Center - Los Angeles

Massachusetts

  • Dana Farber Cancer Institute - Boston

Michigan

  • University of Michigan - Ann Arbor

Tennessee

  • Tennessee Oncology - Nashville

Ontario

  • Princess Margaret Cancer Centre - Toronto

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2023-10-05
Est. Completion 2027-05
Phase Phase 1

Sponsor

LigaChem Biosciences

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05941507

The ClinicalTrials.gov registry entry for NCT05941507 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (52% higher). The listed sponsor is LigaChem Biosciences, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Anti-PD-1 monoclonal antibody is the first listed.

NCT05941507 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Texas, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05941507 about?

NCT05941507 is a clinical study titled "A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors". This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanc...

What is the current status of trial NCT05941507?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2023-10-05. Estimated completion is 2027-05.

What conditions does trial NCT05941507 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT05941507?

The interventions under investigation include: Anti-PD-1 monoclonal antibody (DRUG), LCB84 (DRUG).

Who is sponsoring clinical trial NCT05941507?

This trial is sponsored by LigaChem Biosciences, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05941507 being conducted?

This trial has 8 study locations across California, Massachusetts, Michigan, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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