A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
NCT ID: NCT05941507
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
300 participants
INTERVENTIONAL
2023-10-05
2027-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LCB84 monotherapy
IV infusion Q3W
LCB84
TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug
LCB84 + anti-PD-1
IV infusion Q3W
LCB84
TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug
Anti-PD-1 monoclonal antibody
anti-PD-1 Ab
Interventions
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LCB84
TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug
Anti-PD-1 monoclonal antibody
anti-PD-1 Ab
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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AntibodyChem Biosciences, Inc.
UNKNOWN
LigaChem Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rodrigo Ruiz-Soto, MD
Role: STUDY_DIRECTOR
AntibodyChem Biosciences
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Tennessee Oncology
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LCB84-1001
Identifier Type: -
Identifier Source: org_study_id
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