LP-184 for Solid Tumors

Recruiting at 9 trial locations

Overseen By Anthony Olszanski, MD

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

Trial Summary

What is the purpose of this trial?

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

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.

What makes the drug LP-184 unique for treating solid tumors?

The drug LP-184 is unique because it may utilize advanced delivery systems like PEGylation, which enhances drug accumulation in tumors through the enhanced permeability and retention (EPR) effect, potentially improving its effectiveness and reducing side effects compared to traditional treatments. ^{1 2 3 4 5}

Research Team

Reggie Ewesuedo, MD

Principal Investigator

Lantern Pharma Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tumor burden talks in cancer treatment with PEGylated liposomal drugs. [2021]

2. United States 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. [2018]

3. Switzerland 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. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical uses of pegylated pharmaceuticals in oncology. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A biodistribution study of solid lipid-polyethyleneimine hybrid nanocarrier for cancer RNAi therapy. [2018]