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Study of LP-184 in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Study of LP-184 in Patients With Advanced Solid Tumors

A Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients With Advanced or Metastatic Solid Tumors

NCT05933265•Lantern Pharma Inc.

Summary

The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available. The secondary objectives are to characterize the PK of LP-184 and its metabolites in plasma and assess clinical activity of LP-184. Participants will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, PK, and clinical activity

Detailed Description

Patients who meet all eligibility criteria will be enrolled to receive treatment with LP-184 at a dose determined based on the available cohort at the time of each patient's enrollment. Patients will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, PK, and clinical activity. Dose escalation is planned with minimum of 3 patient cohorts (starting at dose level 1). After selection of the maximum tolerated dose (MTD), additional patients will be enrolled at two dose levels, including the MTD, as determined by the Safety Review Committee, until at least 10 patients each are treated at each dose to determine the recommended phase 2 dose.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years of age at the time of consent
•2. Provided signed written ICF and voluntary consent prior to any mandatory study-specific procedures, sampling, and analyses.
•3. Have a histologically or cytologically documented advanced solid tumor that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available.
•Note: patients with certain tumor types such as those with relatively high prevalence of DDR gene alterations and/or PTGR1 over expression (e.g., triple negative breast cancer, lung, prostate, ovarian, pancreatic, bladder, and GBM) may be preferentially enrolled in Phase 1a.
•4. ECOG performance status 0-1 or Karnofsky performance scale \>60 for GBM patients.
•5. Patients must have measurable disease per RECIST 1.1 or RANO 2.0 criteria as applicable.
•Note: patients without measurable disease may be eligible, following discussion with the investigator and the sponsor, if the patient presents with non-measurable but evaluable disease of any size unequivocally attributable to advanced solid tumor.
•6. Patients must have life expectancy \>3 months.
•7. Adequate organ function at screening defined as:
•Liver Function
+24 more criteria

Exclusion Criteria

•1. Exposure to anti-cancer therapy within 2 weeks or within at least 5 half-lives of the anticancer agent whichever is shorter; or 4 weeks from any biologics/immunotherapies or any investigational therapy prior to the first dose of LP-184.
•Note: Low dose steroids (oral prednisone or equivalent ≤20 mg/day, except patients with GBM), localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone-releasing hormone agonists for prostate cancer and treatment with bisphosphonates and RANKL inhibitors are not criteria for exclusion if such therapy has not been changed within 4 weeks before LP-184 treatment.
•2. Any history of retinopathy and/or macular degeneration (without specifications or grades).
•3. Has received radiation within 4 weeks of Cycle 1 Day 1. Unless the tumor at the site of treatment continues to increase in size after the patient has completed radiotherapy treatment.
•4. Infection requiring antibiotics, antivirals, or antifungals within 1 week prior to first dose of study drug, unless such infection is adequately controlled (defined as exhibiting no ongoing signs/symptoms related to the infection and with clinical improvement). In the case of prophylactic use of these agents, discussion with the Medical Monitor is required prior to enrollment.
•5. Hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen \[HbsAg\] or antibody to hepatitis C virus with confirmatory testing) or known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
•6. Are pregnant or breastfeeding. (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
•7. Have clinically significant cardiac disease including:
•* New York Heart Association Class IV heart failure.
•* Myocardial infarction or stroke ≤3 months prior to the first dose of LP-184.
+13 more criteria

Locations (9)

Highlands Oncology Group

Springdale, Arkansas, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Northwest Oncology & Hematology

Rolling Meadows, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Norton Healthcare, Inc.

Louisville, Kentucky, United States

John Hopkins - The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

UT Health Science Center San Antonio

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

Key Dates

Start Date

June 9, 2023

Primary Completion Date

February 28, 2025

Completion Date

September 9, 2025

Last Updated

March 6, 2025

Enrollment

175

ESTIMATED participants

Conditions

Advanced Solid TumorMetastatic Solid TumorGBMTNBC - Triple-Negative Breast CancerNSCLCPancreatic AdenocarcinomaDDR Gene Mutation

Interventions

LP-184

DRUG

Spironolactone

DRUG

Olaparib

DRUG

Contacts

Lyza Trejo

CONTACT

+1 972-277-1136 lyza@lanternpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of LP-184 in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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