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, in adults with hard-to-treat cancers. It aims to find the safest dose and understand how the drug works in the body.

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.

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+