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New treatment option for Advanced Solid Tumors
Official title A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05941507
What this study is testing
What is LCB84?
LCB84 is an investigational medicine, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Active or progressing central nervous system (CNS) metastases or any evidence of leptomeningeal disease. Note: Patients with stable or treated CNS...
- 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...
- Concomitant use of systemic steroids at dose of \>10 mg of prednisone or its equivalent per day (exception for brain metastases, as described in...
See the full eligibility 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...
- 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
- 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)...
- 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 exclusion criteria #1 above).
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; Nashville, Tennessee, United States; Dallas, Texas, United States; Houston, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.