LP-284 for Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Lantern Pharma Inc.

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

Eligibility Criteria

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 am 18 years or older.

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Trial Timeline

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

Treatment Details

Interventions

LP-284 (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.

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

🇺🇸 Approved in United States as LP-284 for: