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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

Study Summary

This trial tests the safety and effectiveness of LP-284 in people with cancer. It will find the highest dose that can be taken and how it affects cancer.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible to enroll in this medical experiment?

"Presently, this clinical trial is not accepting participants. Published on 30th November 2023 and last updated 9th November 2023, it has ceased recruitment for the time being. Nevertheless, there are still 2,259 other medical studies in progress that patients can join."

Answered by AI

What are the chief aims of this trial?

"Over the course of 12 months, the primary goal of this clinical trial is to identify a recommended Phase 2 dose (RP2D) for LP-284. Secondary objectives include characterizing pharmacokinetics (PK), measuring overall response rates and duration of response as per Lugano Criteria for lymphoma patients, assessing safety and tolerability through adverse events grading according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE 5.0) , and recording changes in laboratory parameters, vital signs, and electrocardiograms (ECGs)."

Answered by AI

What has been the federal agency's stance on LP-284 in its Phase 1 Single Arm Multicenter Study?

"Our safety ranking for LP-284, which is in Phase 1 of its clinical trials, was 1 out of 3 due to the lack of supportive data regarding efficacy and limited information on safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of LP-284 in Relapsed or Refractory Lymphomas and Solid Tumors

2023. "A Study of LP-284 in Relapsed or Refractory Lymphomas and Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132503.