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A Study of LP-284 in Relapsed or Refractory Lymphomas and Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:
A Phase 1, Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of IV LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors

Clinical Trial Summary

The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of LP-284 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) in patients with relapsed or refractory (R/R) lymphomas and solid tumors. The secondary objectives are to characterize the pharmacokinetics (PK) of LP-284 and to assess clinical activity of LP-284.

Clinical Trial Description

This FIH study is an open-label Phase 1a/1b dose escalation and dose expansion study in adult patients with R/R lymphoma and solid tumors. Patients who provide informed consent and meet the eligibility criteria for the study will be enrolled and treated with LP-284 administered intravenously (IV) on Days 1, 8, 15 of a 28-day schedule. The study will be conducted in 2 parts: dose escalation with MTD and/or RP2D confirmation (Phase 1a) and dose expansion (Phase 1b). Up to 30 evaluable patients will be enrolled in Phase 1a; the total number of patients will depend on the number of dose levels explored. Up to 40 evaluable patients will be enrolled in each of the 2 cohorts of MCL and DLBCL tumors in Phase 1b. Patients will remain on study treatment for up to a total of one-year OR until disease progression, unacceptable toxicity, withdrawal of consent, any study-specific discontinuation criteria are met, or the Investigator determines that it is in the best interest of the patient to discontinue study treatment, whichever is shorter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06132503
Study type Interventional
Source Lantern Pharma Inc.
Contact Lyza Trejo
Phone 972-277-1136
Email lyza@lanternpharma.com
Status Recruiting
Phase Phase 1
Start date January 3, 2023
Completion date November 30, 2028
View Details
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