Actively Recruiting
Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors
Led by Lantern Pharma Inc. · Updated on 2026-05-04
110
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older on the day of signing informed consent
- Able to provide signed informed consent and comply with study requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening
- For lymphoma patients: at least one measurable disease site with specific size and PET scan positivity
- Adequate liver, kidney, electrolyte, and bone marrow function as defined by study lab criteria
- Women of child-bearing potential must agree to use effective contraception and have a negative pregnancy test before first dose
- Men must agree to use effective contraception and avoid sperm donation during and for 3 months after treatment
- Phase 1a: confirmed diagnosis of B-cell non-Hodgkin lymphoma or advanced solid tumor refractory or relapsed after at least two prior treatments or no standard treatment available
- Phase 1b: confirmed diagnosis of diffuse large B-cell lymphoma or mantle cell lymphoma relapsed or refractory after at least two prior treatments
- Archival tumor tissue preferred but optional; tumor alteration status documented for Phase 1b
- For solid tumors: measurable or non-measurable disease per RECIST 1.1 at screening
You will not qualify if you...
- History or suspicion of central nervous system lymphoma, meningeal involvement, or metastases
- Other active malignancies within 2 years except certain localized skin, prostate, or in situ carcinomas
- Clinically significant adverse events not returned to baseline or Grade 1 or lower before first dose unless approved
- Unstable cardiovascular conditions including symptomatic ischemia, certain conduction abnormalities, heart failure class III or higher, or recent heart attack
- Congenital long QT syndrome or prolonged QT interval unless specific exceptions apply
- Recent thromboembolic or cerebrovascular events within 6 months before first dose
- Infection requiring antibiotics, antivirals, or antifungals within 1 week before first dose unless controlled
- Active hepatitis B or C infection or HIV
- Psychiatric or medical conditions interfering with study participation or safety
- Pregnancy or breastfeeding
- Prior allogeneic stem cell transplant
- Recent autologous stem cell transplant within 6 months or progression within 6 months post transplant
- Radiation or major surgery within 4 weeks prior to first dose unless exceptions apply
- Live vaccine within 1 month before first dose
- Recent anti-cancer therapy within 2 weeks or up to 4 weeks for biologics/immunotherapies
- Completed SARS-CoV-2 vaccine within 14 days before first dose
- Unable or unwilling to comply with study requirements
- Dependency on sponsor, investigator, or study site
- Institutionalized by official or judicial order
- Male patients with pregnant partners or unwilling to use contraception as required, and females of childbearing potential unwilling or unable to use contraception as required
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
Research Team
S
Sandra Sinclair, BSBA, MHA/Ed, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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