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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: Recruiting Phase 1 study of Advanced Solid Tumors, sponsored by LigaChem Biosciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence and severity of AEs and SAEs
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-10-05 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT05941507 shows while recruiting
NCT05941507 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (52% higher).
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 lists 8 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT05941507's enrollment target sits among peer trials
300 25th of 144 higher than 120 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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