NCT05941507 · LigaChem Biosciences, Inc.
A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
What this study is about
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 gradually increasing doses (Phase 1) followed by dose expansion (Phase 2).
View original scientific description
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.
Interventions
DRUG
LCB84
TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug
DRUG
Anti-PD-1 monoclonal antibody
anti-PD-1 Ab
Primary outcome measures
Safety of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1 and 2)
Time frame: 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)
Time frame: Up to 24 months
Based on tolerability, preliminary anti tumor activity, and pharmacokinetics
Objective Response Rate (Phase 2)
Time frame: Up to 24 months
Assessed by RECIST 1.1, iRECIST, and RANO-BM
Clinical Benefit Rate (Phase 2)
Time frame: Up to 24 months
Assessed by RECIST 1.1, iRECIST, and RANO-BM
Duration of Response (Phase 2)
Time frame: Up to 24 months
Assessed by RECIST 1.1, iRECIST, and RANO-BM
Time to Progression (Phase 2)
Time frame: Up to 24 months
Assessed by RECIST 1.1, iRECIST, and RANO-BM
Progression Free Survival (Phase 2)
Time frame: Up to 24 months
Assessed by RECIST 1.1, iRECIST, and RANO-BM
Overall Survival (Phase 2)
Time frame: Up to 24 months
Survival rates
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Los Angeles, California
- Boston, Massachusetts
- Ann Arbor, Michigan
- Nashville, Tennessee
- Dallas, Texas
- Houston, Texas
Collaborators
AntibodyChem Biosciences, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2025 · Source of record for eligibility and locations