What side effects are associated with this type of intervention?

Common treatments for lymphoma, including investigational therapies like LP-284, often involve chemotherapy and immunotherapy. Chemotherapy agents such as cyclophosphamide, vincristine, doxorubicin, and dexamethasone can cause side effects like nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Immunotherapies, such as those involving monoclonal antibodies (e.g., rituximab), can lead to infusion reactions, fever, chills, and potential allergic reactions. Additionally, targeted therapies and newer agents may cause specific side effects like liver impairment, hypertension, and thromboembolism. It is essential to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of lymphoma, particularly for relapsed or refractory cases. These include monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab, which target CD20 on B-cells. Additionally, Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib have been approved for various types of lymphoma. Other notable approvals include the BCL2 inhibitor venetoclax and the combination of bendamustine with rituximab. These treatments aim to improve outcomes for patients with difficult-to-treat lymphomas, similar to the investigational therapy LP-284.

What other types of research exist?

Promising novel alternatives to LP-284 for lymphoma patients include Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib, the BCL2 inhibitor venetoclax, and monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab. These agents are being evaluated in various combinations and have shown potential in clinical trials for treating lymphomas.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 more

Secondary 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 more

Awards & 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.

0 / 2Eligibility criteria met

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.