LP-184 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Lantern Pharma Inc.

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

Disqualifiers: Retinopathy, Hepatitis, HIV, others

No Placebo Group

Approved in 1 Jurisdiction

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.

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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.

Trial 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

Participant Groups

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.

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:

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

John Hopkins - The Sidney Kimmel Comprehensive Cancer Center Indianapolis, IN

UT Health Science Center San Antonio San Antonio, TX

John Hopkins - The Sidney Kimmel Comprehensive Cancer Center Baltimore, MD

Fox Chase Cancer Center Philadelphia, PA

More Trial Locations

Who Is Running the Clinical Trial?

Lantern Pharma Inc. Lead Sponsor

References

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

Tumor burden talks in cancer treatment with PEGylated liposomal drugs. [2021] PEGylated liposomes are important drug carriers that can passively target tumor by enhanced permeability and retention (EPR) effect in neoplasm lesions. This study demonstrated that tumor burden determines the tumor uptake, and also the tumor response, in cancer treatment with PEGylated liposomal drugs in a C26/tk-luc colon carcinoma-bearing mouse model.

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] To evaluate the efficacy and safety of a distearoylphosphatidylcholine pegylated liposomal doxorubicin, Lipo-Dox, in platinum-resistant or refractory epithelial ovarian cancer.

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] Polyethylene glycol (PEG) coated Poly lactic-co-glycolic acid (PLGA) nanoparticles (NPs) for cancer treatment are biocompatible, nonimmunogenic and accumulate in tumour sites due to the enhanced permeability and retention (EPR). Doxorubicin (DOX) is a potent but cardiotoxic anticancer agent. Hyaluronic acid (HA) occurs naturally in the extra-cellar matrix and binds to CD44 receptors which are overexpressed in cancer metastasis, proven to be characteristic of cancer stem cells and responsible for multidrug resistance. In this study, an athymic mice model of breast cancer metastasis was developed using red fluorescent protein (RFP)-labelled triple negative cancer cells. The animals were divided into four treatment groups (Control, HA-PEG-PLGA nanoparticles, PEG-PLGA nanoparticles, and Free DOX). The tumour size growth was assessed until day 25 when animals were sacrificed. Mice treated with HA-PEG-PLGA NPs inhibited tumour growth. The tumour growth at day 25 (118% ± 13.0) was significantly (p

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

Clinical uses of pegylated pharmaceuticals in oncology. [2019] A number of agents that are used in the treatment of cancer have a suboptimal pharmacokinetic profile that necessitates prolonged or repetitive administration. Pegylation of these agents may help overcome these shortcomings without compromising the agents' efficacy. Several such pegylated agents have now been developed and evaluated in patients with oncology-related disorders. Pegfilgrastim (a pegylated form of filgrastim) has shown efficacy and tolerability that are at least equivalent to those of filgrastim in patients with chemotherapy-induced neutropenia and, unlike unmodified filgrastim, is effective with only one administration per chemotherapy cycle. Other promising pegylated agents are pegylated liposomal doxorubicin, which appears to be more effective and less cardiotoxic than unmodified or liposome-encapsulated doxorubicin, and peginterferon alpha-2a, as once-weekly treatment for renal cell carcinoma. Pegylated agents are likely to be more convenient for patients than the standard formulations, and the improved pharmacokinetics will enhance the clinical utility of these agents.

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

A biodistribution study of solid lipid-polyethyleneimine hybrid nanocarrier for cancer RNAi therapy. [2018] Solid lipid-polymer hybrid nanocarrier (LPN) was previously reported to achieve high siRNA transfection efficiency and induce sustained RNAi-based chemosensitizing effect at cellular level. In this study, our objectives were to evaluate the in vivo biodistribution of LPNs in a prostate cancer model and determine the factors that potentially affect tumor penetration by LPNs. The LPN formulation with the highest transfection efficiency (64%) and stability was selected for the study. Mice bearing tumors of PC-3Mcells were treated with LPNs labeled with IR780 or AF647-siRNA. Near infrared imaging showed that LPNs achieved favorable in vivo biodistribution with high tumor/low organ ratios. LPN accumulation was also observed in liver metastatic tissue. Result of extravasation study confirmed that encapsulated siRNA molecules were able to escape into the tumor tissue at the extravascular area. When LPN levels in large (volume>750mm3) and small (<500mm3) tumors were compared, no significant difference was observed. However, both docetaxel pretreatment (72hbefore LPN) and concurrent docetaxel treatment significantly enhanced the tumor LPN levels by 3.9- and 3.1-fold, respectively (both p<0.01). In conclusion, LPN is a promising carrier system to deliver RNAi therapy to solid malignancies that also receive chemotherapy.