LP-284 for Relapsed or Refractory Lymphomas and Solid Tumors

This study is testing a new drug called LP-284 for adults with lymphomas or solid tumors that have come back (relapsed) or are not responding to other treatments (refractory). LP-284 works by damaging cancer cell DNA, which can lead to cell death. The main goals are to find out how safe LP-284 is, what side effects it might cause, and to determine the highest dose that can be given safely. Researchers will also look at how the body processes LP-284 and if it shows any signs of shrinking tumors. You can join if you are 18 or older and meet other specific health requirements.

Study design
This is an open-label, two-part study (Phase 1a/1b) that will enroll up to 110 adult patients. It involves increasing doses of LP-284 to find the safest and most effective amount.
What's involved
Participants will receive LP-284 intravenously (through a vein) on Days 1, 8, and 15 of a 28-day cycle. Treatment can last up to one year, or until your disease gets worse or side effects become too much.
Compensation
Not stated in the trial record.
Follow-up
The primary safety and dosing evaluations will be measured at 12 months.

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NCT06132503

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Lantern Pharma Inc.
~110 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:LP-284

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: To evaluate the safety and tolerability of escalating doses of LP-284
Measured over 12 months
+3 more outcomes measured
Relapsed or Refractory Lymphomas
Advanced Solid Tumor
1 sites across 1 states
Utah1

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Eligibility criteria

Exclusion

Symptomatic ischemia, or
Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia is excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle branch block will not be excluded), or
Congestive heart failure of New York Heart Association Class ≥ III, or
Myocardial infarction within 3 months prior to Screening. 5. Congenital long QT syndrome, or a QT interval corrected by Fridericia's formula (QTcF) ≥ 470 ms (average of triplicate ECGs) at Screening and/or on C1D1 (pre-dose) except for a documented bundle branch block or unless secondary to pacemaker. In the case of a documented bundle branch block or a pacemaker, discussion with the Medical Monitor is required prior to enrollment. 6. Thromboembolic or cerebrovascular event (i.e., transient ischemic attacks, cerebrovascular accidents, pulmonary emboli, or clinically significant deep vein thrombosis) ≤ 6 months prior to first dose of study drug. 7. Infection requiring antibiotics, antivirals, or antifungals within 1 week prior to first dose of study drug, unless such infection is adequately controlled (defined as exhibiting no ongoing signs/symptoms related to the infection and with clinical improvement). In the case of prophylactic use of these agents, discussion with the Medical Monitor is required prior to enrollment. 8. Hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen \[HbsAg\] or antibody to hepatitis C virus with confirmatory testing) or known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV). 9. Concurrent medical conditions including psychiatric disorders that in the judgment of the Investigator will interfere with the patient's ability to participate or with achieving the objectives of the study or pose a safety risk. 10. The patient is pregnant or breastfeeding. 11. Prior allogeneic hematopoietic stem cell transplant. 12. Autologous hematopoietic stem cell transplant within 6 months prior to first dose of study drug or patient has progressed within 6 months from the day of stem cell infusion. 13. Radiation treatment within 4 weeks prior to the first dose of study drug, unless the tumor site continues to increase in size after the patient has completed radiotherapy treatment. 14. Major surgery requiring general anesthesia within 4 weeks prior to the first dose of study drug. If a patient required general anesthesia within the prior 4 weeks, consultation with the Medical Monitor is required prior to enrollment. 15. Received live vaccine within 1 month prior to the first dose of study drug. 16. Exposure to investigational or non-investigational anti-cancer therapy within 2 weeks or within at least 5 half-lives (up to a maximum of 4 weeks from any biologics/immunotherapies) prior to the first dose of study drug, whichever is shorter.
  • Phase 1a: To evaluate the safety and tolerability of escalating doses of LP-28412 months

    Evaluate the safety and tolerability of escalating doses of LP-284 by measuring the incidence and severity of adverse events (AEs) of escalating doses of LP-284 to determine the maximum tolerated dose (MTD) in patients with relapsed or refractory (R/R) lymphomas and solid tumors

  • Phase 1a: To determine the maximum tolerated dose (MTD).12 months

    Determine the maximum tolerated dose (MTD) of LP-284 by measuring the incidence and severity of adverse events (AEs) graded according to NCI CTCAE 5.0, clinical laboratory, and electrocardiogram (ECG) abnormalities defined as dose-limiting toxicities (DLTs) in patients with relapsed or refractory (R/R) lymphomas and solid tumors

  • Phase 1a: To determine the recommended Phase 2 dose (RP2D).12 months

    Determine the recommended Phase 2 dose (RP2D) of LP-284 by measuring the incidence and severity of adverse events (AEs) graded according to NCI CTCAE 5.0, clinical laboratory, and electrocardiogram (ECG) abnormalities defined as dose-limiting toxicities (DLTs) in patients with relapsed or refractory (R/R) lymphomas and solid tumors

  • Phase 1b: To obtain preliminary estimates of clinical activity of LP-2845 years

    To obtain preliminary estimates of clinical activity by examining the overall response rate, based on Investigator's assessment as per Lugano criteria, of LP-284 in adult patients with relapsed/refractory MCL and DLBCL