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Alkylating Agents

Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-184 in Patients with Advanced Solid Tumors

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

LP-184

Lyza Trejo

Amie Winn

Joseph T Beck

Trong Nguyen

Stefi Guillen

Vu Phan, MD

Nihal Abdulla, MD

Nowsheen Azeemuddin

Bruce Bank, MD

Marina Messinger, MD

Gary E Kay, MD

Ronald J Shade, MD

Tonia Cabai, NP-C

Cristyn Savoia, APN

Christina Raynor

Cassandra Brass

Misty Shields

Michael Buchanan

John Hamm

Ikenna Opurum

Anthony Olszanski, MD

Jasmine Deblanc

Casey Larsen

William McKean, MD

Reggie Ewesuedo, MD

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.

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.

Study of LP-184 in Patients With Advanced Solid Tumors

A Phase 1A Dose Escalation Study of LP-184 in Patients With Advanced or Metastatic Solid Tumors.

Incidence and severity of AEs graded according to the NCI CTCAE, version 5.0, clinical laboratory and ECG abnormalities defined as DLTs

To determine the Cmax from plasma concentration in patients

To determine the Tmax from plasma concentration in patients

To determine the half-life of LP-184 in patients

Area under the Plasma Concentration versus Time Curve (AUC) of LP-184 and major metabolite from time zero to 24 hours post infusion (AUC 0 to 24)

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