NCT06132503

Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Lantern Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Relapsed or Refractory Lymphomas
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	LP-284	LP-284 is a small molecule alkylating agent causing tumor cell death through DNA damage.

Timeline

• Start date: 2023-01-03
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2023-11-15
• Last updated: 2025-03-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study