RecruitingPhase 1Phase 2NCT05933265

Study of LP-184 in Patients With Advanced Solid Tumors

A Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients With Advanced or Metastatic Solid Tumors

Sponsor

Lantern Pharma Inc.

Enrollment

175 participants

Start Date

Jun 9, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Metastatic Solid Tumor TNBC - Triple-Negative Breast Cancer NSCLC Pancreatic Adenocarcinoma GBM DDR Gene Mutation

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new experimental drug called LP-184 in people with advanced solid tumors (cancers that have spread or stopped responding to standard treatment). The study is primarily looking at safety and finding the right dose. **You may be eligible if...** - You are 18 or older - You have a solid tumor cancer that has relapsed or is resistant to standard therapies, or no standard therapy exists - You are in good general health (ECOG 0–1, or Karnofsky score above 60 for brain tumors) - You have at least one measurable tumor - Certain cancer types are especially encouraged, such as triple negative breast cancer, lung, prostate, ovarian, pancreatic, bladder cancer, or glioblastoma **You may NOT be eligible if...** - Your cancer has not been previously treated (unless no standard treatment exists) - Your general health or organ function does not meet study requirements - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLP-184

LP-184 is a small molecule alkylating agent causing tumor cell death through DNA damage.

DRUGSpironolactone

A competitive mineralocorticoid receptor antagonist that inhibits aldosterone-dependent sodium reabsorption/ potassium excretion and lowering blood pressure, as well as degrades the transcription coupled nucleotide excision repair protein ERCC3 to impair DNA repair.

DRUGOlaparib

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.