LP-284 for Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Lantern Pharma Inc.
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests a new drug, LP-284, in adults with hard-to-treat cancers. It aims to find the safest dose and understand how the drug works in the body.
Is the treatment LP-284 a promising treatment for cancer?Yes, LP-284 is a promising treatment for cancer. It is designed to target specific cancer cells and has shown potential to improve survival and quality of life in patients with certain types of cancer, like non-small cell lung cancer and prostate cancer. The treatment aims to boost the body's immune response to fight cancer more effectively.12345
What safety data is available for LP-284 in cancer treatment?The provided research does not contain specific safety data for LP-284 in cancer treatment. The studies focus on other drugs and their adverse events, such as ubrogepant, rimegepant, everolimus, and immunotherapies like anti-CTLA4 and anti-PD1/PD-L1. To find safety data for LP-284, further research specific to this treatment is needed.910111215
What data supports the idea that LP-284 for Cancer is an effective drug?The available research does not provide specific data on the effectiveness of LP-284 for Cancer. Instead, it discusses other treatments and their outcomes, such as olaparib for breast and pancreatic cancer, which showed benefits in survival and quality of life. Without direct data on LP-284, we cannot compare its effectiveness to these treatments.6781314
Do I have to stop taking my current medications for the LP-284 trial?The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had investigational or non-investigational anti-cancer therapy within 2 weeks or within at least 5 half-lives (up to a maximum of 4 weeks from any biologics/immunotherapies) before the first dose of the study drug. Low dose steroids (oral prednisone or equivalent ≤ 20 mg/day) are allowed.
Eligibility Criteria
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.Inclusion Criteria
My lymphoma can be measured and shows up on PET scans.
I can take care of myself and am up and about more than half of my waking hours.
Treatment Details
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.
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.
LP-284 is already approved in United States for the following indications:
🇺🇸 Approved in United States as LP-284 for:
- High-grade B-cell lymphoma with MYC and BCL2 rearrangements
- Mantle cell lymphoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Cancer and Blood Specialty ClinicLos Alamitos, CA
START Mountain RegionWest Valley City, UT
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Who is running the clinical trial?
Lantern Pharma Inc.Lead Sponsor
References
Mechanisms of the antitumoral effect of lipid A. [2006]Bacterial lipopolysaccharide (LPS) and its active component, lipid A, have been used either alone or as adjuvant in therapeutic anticancer vaccines. Lipid A induces various transcription factors via intracellular signaling cascades initiated by their receptor CD14-TLR4. These events lead to the synthesis of cytokines, which either have direct cytotoxic effect or stimulate the immune system. Their antitumoral effect has been demonstrated in animal models as well as clinical trials. Studies in animal models showed that their antitumoral effect relies mostly on the generation of an effective immune response. In humans, the antitumoral effect was correlated with an antibody response and cell-mediated cytotoxicity. So far, some encouraging results have been achieved in phase I and II clinical trials with regards to response and stabilization of the disease, but an expansion of the studies and trials is needed to find the best conditions for their clinical application.
Vaccination with BLP25 liposome vaccine to treat non-small cell lung and prostate cancers. [2005]The identification of tumor-associated/-specific antigens and an increased understanding of the ways in which antigens are processed and presented has led to a revived interest in cancer vaccines as a therapeutic strategy. BLP25 liposome (L-BLP25) vaccine is a cancer vaccine that targets the exposed core peptide of the MUC1 tumor-associated antigen. Studies in advanced-stage non-small cell lung cancer demonstrate that L-BLP25 vaccine has the potential to extend the survival of patients with Stage IIIB locoregional non-small cell lung cancer and maintain quality of life for longer. L-BLP25 vaccine also shows promise for prostate cancer patients, having the potential to prolong prostate-specific antigen doubling time in men with biochemical failure post prostatectomy. These clinically meaningful results with a relatively nontoxic therapeutic vaccine are very encouraging and suggest potential for L-BLP25 to fulfill an unmet medical need.
Randomized phase IIB trial of BLP25 liposome vaccine in stage IIIB and IV non-small-cell lung cancer. [2021]To evaluate the effect of BLP25 liposome vaccine (L-BLP25) on survival and toxicity in patients with stage IIIB and IV non-small-cell lung cancer (NSCLC). Secondary objectives included health-related quality of life (QOL) and immune responses elicited by L-BLP25.
A multicenter open-label study to assess the safety of a new formulation of BLP25 liposome vaccine in patients with unresectable stage III non-small-cell lung cancer. [2021]BLP25 liposome vaccine (L-BLP25) is an innovative therapeutic cancer vaccine designed to induce an immune response resulting in elimination of tumor cells expressing the MUC1 antigen, which is overexpressed in non-small-cell lung cancer (NSCLC). Manufacturing modifications have produced subtle changes to the lipid A acyl chain composition of L-BLP25. This open-label phase II study was conducted to evaluate the safety of the new formulation in patients with unresectable stage IIIA/IIIB NSCLC.
Antitumor effects of L-BLP25 antigen-specific tumor immunotherapy in a novel human MUC1 transgenic lung cancer mouse model. [2021]L-BLP25 antigen-specific cancer immunotherapeutic agent is currently in phase III clinical trials for non-small cell lung cancer. Using a novel human MUC1 transgenic (hMUC1.Tg) lung cancer mouse model, we evaluated effects of L-BLP25 combined with low-dose cyclophosphamide (CPA) pretreatment on Th1/Th2 cytokine production and antitumor activity.
The level of patient-reported outcome reporting in randomised controlled trials of brain tumour patients: a systematic review. [2022]To determine the net clinical benefit of a new treatment strategy, information on both survival and patient-reported outcomes (PROs) is required. However, to make an adequately informed decision, PRO evidence should be of sufficiently high quality.
Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 6: creating national initiatives to support development and use-the PROMIS example. [2017]Patient-reported outcome (PRO) data are beneficial to a range of stakeholders including patients, clinicians, researchers, national funding and regulatory agencies, health system administrators, and policymakers.
Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions. [2020]Patient-reported outcome measures can be used to capture the patient's experience with disease and treatment. Immunotherapy agents including the anti-programmed death receptor-1/programmed death-ligand-1 inhibitor therapies have unique symptomatic side effects and patient-reported outcome data can help to characterize the benefits and burdens associated with therapy.
[Management of adverse events associated with cancer immunotherapy]. [2019]Management of adverse events associated with cancer immunotherapy The advent of the new anti-CTLA4 and anti-PD1/PD-L1 immunotherapies is a revolution in medical oncology. First, their mechanism of action is a real paradigm shift: instead of targeting the tumor cell itself, these treatments seek to overcome immunosuppression induced by the tumor or its microenvironment. By lifting the brakes of the immune system, these immune checkpoints blockers can induce prolonged anti-tumor responses and increase patient survival. These new immunotherapies also have a different toxicity profile compared to conventional anti-cancer treatments, known as immune-related adverse events. They result from the activation of the immune system against normal tissues and can trigger autoimmune diseases. This singular profile of toxicity prompts us to modify our clinical practice.
Anti-PD-1 and anti-PD-L1 drugs treatment-related adverse events for patients with cancer: Protocol for an overview of systematic reviews with meta-analyses. [2023]Anti-programmed cell death 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) drugs treatment-related adverse events (AEs) are not uniform based on current study for patients with cancer. The study aimed to provide a complete toxicity profile and toxicity spectrum for anti-PD-1 and anti-PD-L1 drugs.
Stomatitis And Everolimus: A Review Of Current Literature On 8,201 Patients. [2022]Oral toxicities, such as mucositis and stomatitis, are some of the most significant and unavoidable side effects associated with anticancer therapies. In past decades, research has focused on newer targeted agents with the aim of decreasing the rates of side effects on healthy cells. Unfortunately, even targeted anticancer therapies show significant rates of toxicity on healthy tissue. mTOR inhibitors display some adverse events, such as hyperglycemia, hyperlipidemia, hypophosphatemia, hematologic toxicities, and mucocutaneous eruption, but the most important are still stomatitis and skin rash, which are often dose-limiting side effects.
Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database. [2021]The aim of our study was to analyze adverse events (AEs) associated with radium-223 using real life data from Eudra-Vigilance (EV) database.
Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. [2023]The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety.
Patient-centered outcomes in the POLO study of active maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. [2023]The phase 3 POLO study demonstrated a significant progression-free survival (PFS) benefit and preserved health-related quality of life (HRQOL) for active maintenance treatment with olaparib vs placebo in patients with metastatic pancreatic cancer and a germline BRCA mutation. Here, we present a post hoc analysis of the patient-centered outcomes: time without significant symptoms of disease progression or toxicity (TWiST) and quality-adjusted TWiST (Q-TWiST).
Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. [2023]In this study, we fill this gap in knowledge by updating the safety profile of ubrogepant and rimegepant via disproportionality analysis in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), a US-based database registering spontaneous reports.