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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Reggie Ewesuedo, MD · STUDY_DIRECTOR · [email protected]
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- 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