LP-184 for Solid Tumors

Recruiting at 9 trial locations

Overseen By Cristyn Savoia, APN

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Lantern Pharma Inc.

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Retinopathy, Hepatitis, HIV, 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: 2

Duration: 6 weeks

175 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LP-184 for individuals with advanced solid tumors unresponsive to other treatments. The main aim is to determine LP-184's safety and establish the correct dosage for patients. The trial also examines how the drug behaves in the body and its effectiveness in shrinking tumors. It targets individuals with solid tumors, particularly those with types like triple-negative breast cancer or lung cancer, who haven't benefited from standard treatments. Participants will receive LP-184 infusions on specific days in a three-week cycle, at least twice. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had anti-cancer therapy within 2 weeks or within at least 5 half-lives of the anticancer agent before starting the trial, and certain other treatments like radiation must be completed 4 weeks prior.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, LP-184 proved to be safe. Research shows that about 48% of patients with solid tumors benefited from LP-184 without serious side effects when given at or above the recommended dose. While detailed safety information is still being collected, these early results suggest that LP-184 is generally well-tolerated. The ongoing studies aim to find the safest and most effective dose, ensuring minimal side effects. As with any new treatment, patient safety remains a top priority, and researchers will continue to monitor it throughout the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about LP-184 because it offers a unique approach to treating advanced or metastatic solid tumors, including triple-negative breast cancer, non-small cell lung cancer, and pancreatic adenocarcinoma, among others. Unlike traditional treatments like chemotherapy, which often target rapidly dividing cells, LP-184 is designed to exploit specific weaknesses in tumor cells with DNA damage repair (DDR) deficiencies, potentially leading to more targeted and effective outcomes. Additionally, in the case of recurrent glioblastoma, LP-184 is being evaluated both alone and in combination with spironolactone to enhance its anti-tumor activity, offering a potentially synergistic effect. The combination of LP-184 with olaparib in hormone receptor-negative and HER2-negative breast cancer represents another innovative approach, aiming to improve safety and effectiveness over existing therapies.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research has shown that LP-184, which participants in this trial may receive, could effectively treat solid tumors. In earlier studies, 48% of patients with these tumors experienced benefits at or above the recommended dose. LP-184 is a new type of drug that targets cancer, particularly in tumors with a specific genetic weakness. Early research also indicates that LP-184 works well against various cancers, such as certain types of breast, lung, and pancreatic cancers. Additionally, LP-184 can effectively reach the brain, which may aid in treating brain tumors like glioblastoma. Overall, initial results suggest LP-184 could be a promising new option for treating these challenging cancers. ^{1 6 7 8 9}

Who Is on the Research Team?

Reggie Ewesuedo, MD

Principal Investigator

Lantern Pharma Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have stopped responding to standard treatments or have no standard options left. They should be relatively healthy otherwise, with a life expectancy over 3 months and stable brain conditions if present. Pregnant or breastfeeding individuals, those with significant heart issues, recent major surgery, or active severe infections are excluded.

Inclusion Criteria

Are you able to carry out your normal daily activities without significant restriction?

Has your disease progressed despite treatment?

Have you ever been a smoker?

Exclusion Criteria

I haven't had cancer treatment within the last 2 weeks or 4 weeks for biologics.

My doctor suspects or has confirmed I have cancer spread to the lining of my brain and spinal cord.

I have not had major surgery in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LP-184 infusion on Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles

6 weeks

2 visits per cycle (in-person)

Dose Escalation

Dose escalation with a minimum of 3 patient cohorts to determine the maximum tolerated dose (MTD)

Varies

Follow-up

Participants are monitored for safety, PK, and clinical activity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LP-184

Trial Overview

The study tests LP-184's safety and the maximum tolerated dose in patients with advanced solid tumors. It also looks at how the body processes LP-184 and its effectiveness against these cancers.

How Is the Trial Designed?

Group I: Supplement C Experimental Treatment 2 Interventions

Phase 1b/2 Expansion cohort of participants with Hormone Receptor (HR)-Negative and HER2-Negative Breast Cancer (TNBC) to evaluate the safety, tolerability and clinical activity of LP-184 in combination with olaparib

Group II: Supplement B Experimental Treatment 2 Interventions

Phase 1b/2 Expansion cohort of participants with recurrent GBM to evaluate the safety, pharmacokinetics and preliminary anti-tumour activity of LP-184 alone and in combination with spironolactone.

Group III: Supplement A Experimental Treatment 1 Intervention

Phase 1b/2 Expansion cohort of participants with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma (PDAC) or other solid tumours with known DDR genomic alterations to determine the optimal dose/RP2D and to obtain preliminary estimates of clinical activity.

Group IV: Master Protocol Experimental Treatment 1 Intervention

A phase 1/2 dose escalation and cohort expansion study of LP-184 in patients with advanced or metastatic solid tumors. A BOIN design will be used to evaluate the safety of LP-184, determine the MTD, and identify the RP2D. 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.

LP-184 is already approved in United States for the following indications:

Approved in United States as LP-184 for:

Who Is Running the Clinical Trial?

Lantern Pharma Inc.

Lead Sponsor

Trials

4

Recruited

390+

Published Research Related to This Trial

HA-PEG-PLGA nanoparticles significantly inhibited tumor growth in an athymic mouse model of breast cancer metastasis, showing a 118% increase in tumor size compared to much higher increases in control and PEG-PLGA groups.

These nanoparticles also reduced metastasis to vital organs like the liver, spleen, colon, and lungs, indicating their potential for targeted cancer treatment, although further studies on pharmacokinetics and toxicity are needed before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Chemotherapeutic Efficacy of Hyaluronic Acid Coated Polymeric Nanoparticles against Breast Cancer Metastasis in Female NCr-Nu/Nu Nude Mice. Almoustafa, HA., Alshawsh, MA., Al-Suede, FSR., et al.[2023]

In a phase II trial involving 29 women with platinum-resistant or refractory epithelial ovarian cancer, Lipo-Dox demonstrated an overall response rate of 23.1%, with a median response duration of 11.6 weeks, indicating its efficacy in this challenging patient population.

The treatment was generally well-tolerated, with most side effects being mild (Grade 1/2), including hand-foot skin reactions (4.5%) and nausea (14.2%), suggesting a favorable safety profile for Lipo-Dox in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegylated liposomal doxorubicin (Lipo-Dox) for platinum-resistant or refractory epithelial ovarian carcinoma: a Taiwanese gynecologic oncology group study with long-term follow-up. Chou, HH., Wang, KL., Chen, CA., et al.[2018]

The solid lipid-polymer hybrid nanocarrier (LPN) demonstrated high transfection efficiency (64%) and effective in vivo biodistribution in a prostate cancer model, achieving high tumor accumulation with low organ toxicity.

Treatment with docetaxel significantly enhanced the accumulation of LPNs in tumors, indicating that combining LPNs with chemotherapy could improve RNAi therapy delivery to solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A biodistribution study of solid lipid-polyethyleneimine hybrid nanocarrier for cancer RNAi therapy. Xue, HY., Tran, N., Wong, HL.[2018]

Pegylated agents, like pegfilgrastim, provide equivalent efficacy and tolerability to their non-pegylated counterparts while allowing for less frequent administration, improving convenience for patients undergoing chemotherapy.

Other pegylated drugs, such as pegylated liposomal doxorubicin and peginterferon alpha-2a, show enhanced effectiveness and reduced side effects, indicating that pegylation can significantly improve the pharmacokinetic profiles of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical uses of pegylated pharmaceuticals in oncology. Crawford, J.[2019]

In a study using a mouse model of colon cancer, it was found that smaller tumors had significantly better uptake of PEGylated liposomal drugs, leading to improved therapeutic outcomes compared to larger tumors.

The combination treatment with PEGylated liposomal vincristine (InVNBL) resulted in the highest tumor growth inhibition and survival rates, highlighting the importance of tumor burden in the efficacy of cancer therapies using these drug carriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor burden talks in cancer treatment with PEGylated liposomal drugs. Lin, YY., Kao, HW., Li, JJ., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05933265?term=LTRN184-1AST23-1&rank=1

Study of LP-184 in Patients With Advanced Solid Tumors

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 ...

2.

ir.lanternpharma.com

ir.lanternpharma.com/news-1/news/news-details/2024/Lantern-Pharmas-Investigational-Drug-Candidate-LP-184-Receives-Second-Fast-Track-Designation-from-FDA-for-Treatment-of-Triple-Negative-Breast-Cancer-TNBC-12-03-2024/default.aspx

Lantern Pharma's Investigational Drug-Candidate, LP-184 ...

This data is particularly significant as it suggests LP-184's potential as a novel therapeutic option for TNBC patients, including those who ...

3.

aacrjournals.org

aacrjournals.org/cancerres/article/83/5_Supplement/P4-01-06/717244/Abstract-P4-01-06-LP-184-an-acylfulvene-class

Abstract P4-01-06: LP-184, an acylfulvene class small ...

LP-184 efficacy was tested in a panel of breast cancer cell lines and patient derived TNBC xenografts models, both sensitive as well as ...

4.

targetedonc.com

targetedonc.com/view/fda-clears-lp-184-ind-for-tnbc-trial-as-monotherapy-parp-inhibitor-combo

FDA Clears LP-184 IND for TNBC Trial as Monotherapy & ...

A phase 1b/2 trial in triple-negative breast cancer will assess LP-184 alone and with a PARP inhibitor in advanced cases.

5.

firstwordpharma.com

firstwordpharma.com/story/5685904

Lantern Pharma Announces Development of Drug ...

New preclinical results presented at SABCS demonstrate LP-184 has superior anti-tumor efficacy for TNBC, as compared to current TNBC ...

6.

cancernetwork.com

cancernetwork.com/view/lp-184-shows-favorable-safety-pharmacokinetics-in-advanced-solid-tumors

LP-184 Shows Favorable Safety, Pharmacokinetics in ...

Clinical benefit with the investigational agent was reported among 48% of patients with solid tumors at or above the therapeutic dose threshold.

7.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/408815

Study of LP-184 in Patients with Advanced Solid Tumors

The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11072798/

LP-184, a Novel Acylfulvene Molecule, Exhibits Anticancer ...

In this study, we investigated antitumor efficacy of LP-184 across a range of HRD solid tumors, including prostate, ovarian, lung, triple-negative breast ...

9.

targetedonc.com

targetedonc.com/view/astsaturov-on-the-phase-1-study-of-lp-184-in-advanced-solid-tumors

Astsaturov on the Phase 1 Study of LP-184 in Advanced ...

The goals of the study are to assess the safety and tolerability of escalating doses of LP-184 to determine the maximum tolerated dose in ...