Actively Recruiting
A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
Led by LigaChem Biosciences, Inc. · Updated on 2025-09-24
300
Participants Needed
8
Research Sites
186 weeks
Total Duration
On this page
Sponsors
L
LigaChem Biosciences, Inc.
Lead Sponsor
A
AntibodyChem Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial 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 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.
CONDITIONS
Official Title
A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed advanced solid tumors refractory to standard treatment
- Measurable disease as defined by RECIST v1.1 or RANO-BM
- Willingness to provide archival tumor tissue or undergo pre-treatment biopsy if needed
- ECOG performance status of 0 or 1
- Adequate organ function including ANC 61.5 x 10^9/L, platelets 6100 x 10^9/L, hemoglobin 9.0 g/dL, and liver enzymes within specified limits
You will not qualify if you...
- Active or progressing central nervous system metastases or leptomeningeal disease
- Persistent toxicities from prior cancer treatments above Grade 1, except alopecia and vitiligo
- Systemic cancer therapy within 5 half-lives or 4 weeks before starting study drug
- Use of systemic steroids above 10 mg prednisone daily except as allowed for brain metastases
- Unstable or untreated brain metastases not meeting stability criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
5
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
6
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
D
David Browning
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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