LP-284 for Cancer

Recruiting at 4 trial locations

Overseen By Lyza Trejo

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Lantern Pharma Inc.

Disqualifiers: CNS lymphoma, Active malignancy, Unstable cardiovascular, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LP-284, to determine its safety and effectiveness for individuals with difficult-to-treat cancers, specifically relapsed or resistant lymphomas and solid tumors. The main goal is to identify the optimal dose for safe use in future studies. This trial may suit those who have tried at least two other treatments without success for their lymphoma or advanced solid tumor. As a Phase 1 trial, participants have the opportunity to be among the first to receive this new treatment and assist researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you must stop taking your current medications. However, you cannot have had any investigational or non-investigational anti-cancer therapy within 2 weeks or within at least 5 half-lives (up to a maximum of 4 weeks for biologics/immunotherapies) before starting the study drug.

Is there any evidence suggesting that LP-284 is likely to be safe for humans?

Research has shown that LP-284 was safe in earlier studies, with most side effects being mild and manageable. The trials aim to find the safest dose that does not cause harm. Testing will determine the highest dose patients can tolerate without serious issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LP-284 because it could offer a novel approach for treating certain types of lymphoma, specifically diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). Unlike traditional chemotherapy, which often targets rapidly dividing cells indiscriminately, LP-284 is designed to maximize effectiveness while minimizing side effects by identifying the most tolerable and optimal doses. This targeted approach aims to improve safety and potentially enhance the drug's efficacy, which is why there's significant interest in its potential to offer better outcomes for patients with these aggressive cancers.

What evidence suggests that LP-284 might be an effective treatment for cancer?

Research has shown that LP-284 yields promising results in treating certain cancers. In earlier studies, LP-284 helped a patient with a hard-to-treat type of lymphoma, where other treatments like CAR-T and bispecific antibodies failed. Specifically, the cancer became inactive and less noticeable after using LP-284. Additionally, in lab tests, LP-284 proved very effective against various blood cancer cells, particularly in non-Hodgkin lymphoma (NHL). This early evidence suggests LP-284 might be effective for lymphomas and solid tumors that have recurred or are difficult to treat. Participants in this trial will receive LP-284 to further evaluate its safety and clinical activity. ^{2 6 7 8 9}

Who Is on the Research Team?

Reggie Ewesuedo, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

This criterion applies to all patients participating in Phase 1a and Phase 1b of the trial.

My liver is working properly.

I can sign and agree to follow the study's rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase 1a)

Participants receive escalating doses of LP-284 to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

12 months

Visits on Days 1, 8, 15 of a 28-day cycle

Dose Expansion (Phase 1b)

Participants receive LP-284 at the RP2D to further evaluate safety and obtain preliminary estimates of clinical activity

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LP-284

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-284 Experimental Treatment 1 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.

LP-284 is already approved in United States for the following indications:

Approved in United States as LP-284 for:

• High-grade B-cell lymphoma with MYC and BCL2 rearrangements
• Mantle cell lymphoma

Who Is Running the Clinical Trial?

Lantern Pharma Inc.

Lead Sponsor

Trials

4

Recruited

390+

Citations

1. ir.lanternpharma.com ir.lanternpharma.com/news-1/news/news-details/2025/Lantern-Pharma-Reports-Complete-Response-in-Heavily-Pre-Treated-Lymphoma-Patient-with-LP-284-in-Phase-1-Clinical-Trial/default.aspx

Lantern Pharma Reports Complete Response in Heavily ... The complete metabolic response achievement positions LP-284 to seek a future role within a global blood cancer market focused on B-cell cancer ...

2. biospace.com biospace.com/press-releases/lantern-pharma-presents-lp-284-clinical-data-at-25th-ll-m-congress-highlighting-complete-response-in-therapeutically-exhausted-dlbcl-patient-therapeutic-potential-in-advanced-b-cell-cancers

Lantern Pharma Presents LP-284 Clinical Data at 25th ... AI-advanced drug candidate achieves complete metabolic response after two cycles in patient who failed CAR-T and bispecific antibody ...

3. oncotarget.com oncotarget.com/article/28454/text/

LP-284, a small molecule acylfulvene, exerts potent ... We found that LP-284 exerts nanomolar potency in a panel of hematological cancer cell lines including fifteen NHL cell lines.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06132503?intr=LP284&rank=1

Safety, Pharmacokinetics, and Clinical Activity of LP-284 in ... 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) ...

5. firstwordpharma.com firstwordpharma.com/story/5983308

Lantern Pharma Reports Complete Response in Heavily ... The patient achieved complete metabolic response with non-avid lesions after completing just two 28-day cycles of LP-284 administered on days one, eight, and ...

6. ir.lanternpharma.com ir.lanternpharma.com/news-1/news/news-details/2025/Lantern-Pharma-Presents-LP-284-Clinical-Data-at-25th-LLM-Congress-Highlighting-Complete-Response-in-Therapeutically-Exhausted-DLBCL-Patient--Therapeutic-Potential-in-Advanced-B-Cell-Cancers-/default.aspx

Lantern Pharma Presents LP-284 Clinical Data at 25th ... Favorable early safety profile with primarily Grade 1-2 adverse events,; Efficacy unaffected by TP53 mutation or lymphoma surface antigen ...

7. clinical-lymphoma-myeloma-leukemia.com clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(24)01535-0/fulltext

ABCL-524 Phase 1 Clinical Trial of LP-284, a Novel ... Following the determination of the MTD and/or RP2D(s), the safety and tolerability of the expansion doses will be confirmed in patients with R/R diffuse large B ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10259262/

LP-284, a small molecule acylfulvene, exerts potent antitumor ... We found that LP-284 exerts nanomolar potency in a panel of hematological cancer cell lines including fifteen NHL cell lines. In vivo, LP-284 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0006497124114759

High-risk MCL: recognition and treatment Preclinical studies support the clinical development of LP-284 in relapsed and refractory B-cell lymphomas. Blood, 142 (suppl 1) (2023), p ...