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Study of LCB84 for Advanced Solid Tumors

This study is testing LCB84, an antibody-drug conjugate (a targeted therapy that delivers chemotherapy directly to cancer cells), alone and in combination with an anti-PD-1 antibody (a type of immunotherapy that helps your immune system fight cancer). It's for people with advanced solid tumors that haven't responded to standard treatments or for which no standard treatment exists. The study aims to find a safe and effective dose of LCB84, both alone and in combination, and to see how many people respond to the treatment. This is a first-in-human study, meaning it's one of the first times these treatments are being given to people.

Study design
This is a Phase 1/2 interventional study with a planned enrollment of 300 participants. It involves increasing doses of LCB84 alone, followed by increasing doses of LCB84 in combination with an anti-PD-1 antibody.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 48 months. The study will also measure how well the treatment works for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05941507

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
LigaChem Biosciences, Inc.
~300 participants
Updated 2025-09-24 on ClinicalTrials.gov
What's tested:LCB84Anti-PD-1 monoclonal antibody

At a glance

Recruiting sites
6 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1 and 2)
Measured over Up to 48 months
+7 more outcomes measured

Conditions

Advanced Solid Tumors

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Where it's being run

8 sites across 6 states
Texas3
California1
Massachusetts1
Michigan1
Tennessee1
Ontario1

Study leadership

  • Rodrigo Ruiz-Soto, MD · STUDY_DIRECTOR · AntibodyChem Biosciences

Who to contact

David Browning
[email protected]
+1-615-975-7776
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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)

Exclusion

Active or progressing central nervous system (CNS) metastases or any evidence of leptomeningeal disease.
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.

What this trial measures

  • Safety of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1 and 2)Up to 48 months

    Incidence and severity of AEs and SAEs

  • Recommended Phase 2 Dose of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1)Up to 24 months

    Based on tolerability, preliminary anti tumor activity, and pharmacokinetics

  • Objective Response Rate (Phase 2)Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  • Clinical Benefit Rate (Phase 2)Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  • Duration of Response (Phase 2)Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  • Time to Progression (Phase 2)Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  • Progression Free Survival (Phase 2)Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  • Overall Survival (Phase 2)Up to 24 months

    Survival rates