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

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLCB84 and Anti-PD-1 monoclonal antibody

The study team can explain what participation involves.

Who it may be forResistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 24, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?LigaChem Biosciences, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: LigaChem Biosciences, Inc.
Interventions being studied: Drug: LCB84; Drug: Anti-PD-1 monoclonal antibody

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Resistant or refractory→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
Phase 2 Dose Expansion\*: select histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment. \*expansion cohort indications to be prioritized based on data from Phase 1 dose escalation.
Prior treatment with TROP2-directed therapy is permitted.
Measurable disease as defined by RECIST v1.1 or RANO-BM.
Willingness to provide archival tumor tissue when available or to undergo pre-treatment biopsy if not available.
Mandatory pre- and on-treatment biopsies for enrichment cohorts in Phase 1 dose escalation and Phase 2 expansion cohorts if deemed medically feasible and safe.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function as defined by:
Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/µL), without colony-stimulating factor support for the past 14 days
Platelets ≥100.0 x 109/L (100 000/µL)
Hemoglobin ≥9.0 g/dL
Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN (AST, ALT ≤5 x ULN if liver metastases present) Key

Reasons someone may not be able to joinExclusion criteria

Active or progressing central nervous system (CNS) metastases or any evidence of leptomeningeal disease. Note: Patients with stable or treated CNS metastases may be eligible if all of the following criteria are met: 1) localized treatment for brain metastases completed at least 4 weeks prior to the first dose of study drug 2) no new or progressive neurologic symptoms and without need for immediate local therapy, steroids or anticonvulsants for symptom control (stable or decreasing steroid dose (a stable dose of ≤4 mg dexamethasone oral or equivalent) is permitted) 3) stable brain metastases for at least 1 month prior to screening (baseline) brain MRI.
Persistent toxicities from previous systemic antineoplastic treatments \>Grade 1, excluding alopecia and vitiligo.
Systemic antineoplastic therapy (including antiestrogen therapy) within 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of the study drug.
Concomitant use of systemic steroids at dose of \>10 mg of prednisone or its equivalent per day (exception for brain metastases, as described in

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Cedars Sinai Medical CenterLos Angeles, California
Dana Farber Cancer InstituteBoston, Massachusetts
University of MichiganAnn Arbor, Michigan
Tennessee OncologyNashville, Tennessee
Mary Crowley Cancer ResearchDallas, Texas
University of Texas Southwestern Medical CenterDallas, Texas
MD Anderson Cancer CenterHouston, Texas
Princess Margaret Cancer CentreToronto, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 24, 2025. Always confirm current availability with the study team.

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