Study of LP-184 in Patients With Advanced Solid Tumors
NCT05933265 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2026-05-04
Summary
The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available. The secondary objectives are to characterize the PK of LP-184 and its metabolites in plasma and assess clinical activity of LP-184.
Participants will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, PK, and clinical activity
Conditions
- Advanced Solid Tumor
- Metastatic Solid Tumor
- GBM
- TNBC - Triple-Negative Breast Cancer
- NSCLC
- Pancreatic Adenocarcinoma
- DDR Gene Mutation
Interventions
- DRUG
-
LP-184
LP-184 is a small molecule alkylating agent causing tumor cell death through DNA damage.
- DRUG
-
A poly (ADP-ribose) polymerase (PARP) inhibitor that impairs homologous recombination (HR) dependent DNA damage repair by trapping PARP1/2 on DNA, leading to synthetic lethality in BRCA1/2-deficient cells.
- DRUG
-
Nivolumab & Ipilimumab
Nivolumab is monoclonal antibody and classified as an immune checkpoint inhibitor. By blocking the PD-1 receptor on the surface of T cells, Nivolumab restores immune cells' ability to recognize and attack cancer cells. Ipilimumab is monoclonal antibody and classified as an immune checkpoint inhibitor. By blocking the CTLA4 protein on the surface of T cells, Ipilimumab activates T-cells and allows T-cells to attack cancer cells.
Sponsors & Collaborators
-
Lantern Pharma Inc.
lead INDUSTRY
Principal Investigators
-
Reggie Ewesuedo, MD · Lantern Pharma Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-09
- Primary Completion
- 2026-07-28
- Completion
- 2026-07-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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