NCT05933265

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Lantern Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Patients who meet all eligibility criteria will be enrolled to receive treatment with LP-184 at a dose determined based on the available cohort at the time of each patient's enrollment. Patients 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. Dose escalation is planned with minimum of 3 patient cohorts (starting at dose level 1). After selection of the maximum tolerated dose (MTD), additional patients will be enrolled at two dose levels, including the MTD, as determined by the Safety Review Committee, until at least 10 patients each are treated at each dose to determine the recommended phase 2 dose.

Conditions

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

Interventions

Type	Name	Description
DRUG	LP-184	LP-184 is a small molecule alkylating agent causing tumor cell death through DNA damage.
DRUG	Spironolactone	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.
DRUG	Olaparib	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.

Timeline

• Start date: 2023-06-09
• Primary completion: 2025-02-28
• Completion: 2025-09-09
• First posted: 2023-07-06
• Last updated: 2025-03-06

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study