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Monoclonal Antibodies
LP-284 for Cancer
Phase 1
Recruiting
Research Sponsored by Lantern Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Lymphoma patients. At least one bi-dimensionally measurable disease site. The lesion must have the greatest transverse diameter of at least 1.5 cm and greatest perpendicular diameter of at least 1.0 cm at baseline. The lesion must be positive on positron emission tomography (PET) scan.
Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, LP-284, in adults with hard-to-treat cancers. It aims to find the safest dose and understand how the drug works in the body.
Who is the study for?
This trial is for adults over 18 with relapsed or refractory lymphomas and solid tumors. Participants must be able to consent, have an ECOG performance status of 0-2, and meet specific criteria for measurable disease sites or assessable advanced lymphoma. They should also have certain liver and renal function levels.
What is being tested?
The study tests escalating doses of LP-284 to find the highest dose patients can tolerate without severe side effects (MTD) and the recommended dose for future Phase 2 trials (RP2D). It will also look at how the body processes LP-284 and its effectiveness against cancer.
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, liver enzyme alterations, or other organ-related issues that will be monitored throughout dosage escalation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma can be measured and shows up on PET scans.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1a: To determine the maximum tolerated dose (MTD).
Phase 1a: To determine the recommended Phase 2 dose (RP2D).
Phase 1a: To evaluate the safety and tolerability of escalating doses of LP-284
+1 moreSecondary study objectives
Phase 1a: To assess clinical activity of LP-284
Phase 1a: To characterize the pharmacokinetics (PK) of LP-284
Phase 1b: To characterize the pharmacokinetics (PK) of LP-284
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-284Experimental Treatment1 Intervention
The Phase 1a dose escalation portion of the study will identify the maximum tolerated dose (MTD) and/or optimal dose(s) of LP-284 as the RP2D, based on all available safety, PK, PD, and/or preliminary efficacy data. Phase 1b will consist of the dose expansion portion in a separate cohort(s) of patients to further evaluate the safety of LP-284 at the RP2D and obtain preliminary estimates of clinical activity of LP-284 in patients with DLBCL and MCL.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for lymphoma include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects.
Targeted therapies, such as Bruton tyrosine kinase (BTK) inhibitors and BCL2 inhibitors, specifically target molecules involved in cancer cell survival and proliferation, offering a more precise approach with potentially fewer side effects. Immunotherapy, including monoclonal antibodies, enhances the immune system's ability to recognize and destroy cancer cells.
These mechanisms are crucial for lymphoma patients as they provide multiple strategies to combat the disease, potentially leading to better outcomes and personalized treatment plans.
The treatment of Burkitt lymphoma in adults.
The treatment of Burkitt lymphoma in adults.
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Who is running the clinical trial?
Lantern Pharma Inc.Lead Sponsor
3 Previous Clinical Trials
147 Total Patients Enrolled
Reggie Ewesuedo, MDStudy Directorreggie@lanternpharma.com
2 Previous Clinical Trials
120 Total Patients Enrolled