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Tests treatment safety and results for Relapsed or Refractory Lymphomas
Official title Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors
ClinicalTrials.gov ID: NCT06132503
What this study is testing
What is LP-284?
LP-284 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory lymphomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of LP-284 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) in patients with relapsed or refractory (R/R) lymphomas and solid tumors. The secondary objectives are to characterize the pharmacokinetics (PK) of LP-284 and to assess clinical activity of LP-284.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All Patients: Phase 1a and Phase 1b
- Male or female aged ≥ 18 years on the day of signing informed consent.
- Patient is capable of giving signed informed consent as described in Section 11.3 which includes compliance with the requirements and restrictions...
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 at screening.
- For Lymphoma patients. At least one bi-dimensionally measurable disease site. The lesion must have a greatest transverse diameter of at least 1.5 cm...
You likely can't join if
- All Patients: Phase 1a and Phase 1b Patients are excluded from the study if any of the following criteria apply:
- History or suspicion of central nervous system (CNS) lymphoma or meningeal involvement or central nervous system (CNS) metastases.
- History of or active concurrent malignancy other than NHL (Phase 1a and Phase 1b) or solid tumor (Phase 1a only) unless the patient has been...
- Clinically significant AEs that have not returned to baseline or ≤Grade 1 based on NCI-CTCAE prior to first dose of study drug, unless approved by...
- Ongoing unstable cardiovascular function:
- Symptomatic ischemia, or
See the full eligibility criteria
Who can join
- All Patients: Phase 1a and Phase 1b
- Male or female aged ≥ 18 years on the day of signing informed consent.
- Patient is capable of giving signed informed consent as described in Section 11.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 at screening.
- For Lymphoma patients. At least one bi-dimensionally measurable disease site. The lesion must have a greatest transverse diameter of at least 1.5 cm and greatest perpendicular diameter of at least 1.0 cm at baseline...
- Adequate organ function at Screening and on C1D1 (pre-dose) defined as: Liver Function i Aspartate aminotransferase (AST), alanine transaminase (ALT) ≤ 3x upper limit of normal (ULN) or \< 5x ULN in cases of documented...
- Women of child-bearing potential (WOCBP) must agree to use highly effective contraceptive methods and avoid egg donation for the duration of study treatment and for 6 months after the last dose of study drug.
- Women of child-bearing potential must have a negative serum pregnancy test at Screening and within 72 hours prior to the first dose of study drug.
- Men must agree to use highly effective contraceptive methods and avoid sperm donation during the study treatment and for 3 months after the last dose of study drug if the partner is a WOCBP. Phase 1a ONLY:
- Histologically confirmed diagnosis of B-cell NHL according to the 2016 World Health Organization (WHO) classification that has relapsed from or is refractory to at least two prior standard of care treatments or tumors...
- Histologically confirmed diagnosis of DLBCL or MCL according to the 2016 WHO classification. DLBCL includes: DLBCL not otherwise specified (NOS) with or without MYC and BCL2 and/or BCL6 rearrangements; Epstein-Barr...
- Relapsed and/or refractory disease to at least two prior standard of care treatments or tumors for which no standard therapies are available.
- Documented tumor alteration status. Archival (preferably collected within 6 months prior to first dose [C1D1]) FFPE tumor sample must be submitted for determination of genomic signature by Lantern Pharma's validated...
What rules you out
- All Patients: Phase 1a and Phase 1b Patients are excluded from the study if any of the following criteria apply:
- History or suspicion of central nervous system (CNS) lymphoma or meningeal involvement or central nervous system (CNS) metastases.
- History of or active concurrent malignancy other than NHL (Phase 1a and Phase 1b) or solid tumor (Phase 1a only) unless the patient has been disease-free for ≥ 2 years. Exceptions to the ≥ 2-year time limit include...
- Clinically significant AEs that have not returned to baseline or ≤Grade 1 based on NCI-CTCAE prior to first dose of study drug, unless approved by the Sponsor. Patients with chronic Grade 2 toxicities may be eligible...
- Ongoing unstable cardiovascular function:
- Symptomatic ischemia, or
- Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia is excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle...
- Congestive heart failure of New York Heart Association Class ≥ III, or
- Myocardial infarction within 3 months prior to Screening.
- Congenital long QT syndrome, or a QT interval corrected by Fridericia's formula (QTcF) ≥ 470 ms (average of triplicate ECGs) at Screening and/or on C1D1 (pre-dose) except for a documented bundle branch block or unless...
- Thromboembolic or cerebrovascular event (i.e., transient ischemic attacks, cerebrovascular accidents, pulmonary emboli, or clinically significant deep vein thrombosis) ≤ 6 months prior to first dose of study drug.
- 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...
- 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...
- Concurrent medical conditions including psychiatric disorders that in the judgment of the Investigator will interfere with the patient's ability to participate or with achieving the objectives of the study or pose a...
- The patient is pregnant or breastfeeding.
- Prior allogeneic hematopoietic stem cell transplant.
- Autologous hematopoietic stem cell transplant within 6 months prior to first dose of study drug or patient has progressed within 6 months from the day of stem cell infusion.
- Radiation treatment within 4 weeks prior to the first dose of study drug, unless the tumor site continues to increase in size after the patient has completed radiotherapy treatment.
- Major surgery requiring general anesthesia within 4 weeks prior to the first dose of study drug. If a patient required general anesthesia within the prior 4 weeks, consultation with the Medical Monitor is required prior...
- Received live vaccine within 1 month prior to the first dose of study drug.
- Exposure to 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) prior to the first dose of study...
- Patient has completed a course of SARS-CoV-2 vaccine within 14 days prior to first dose of study drug.
- Patient is unable or unwilling to comply with all requirements of the study.
- Patient with dependency on the Sponsor, Investigator or study site.
- A person that is committed to an institution by official or judicial order.
- Male patients with partners currently pregnant or male patients able to father children and female patients of childbearing potential who are unwilling or unable to use highly effective methods of contraception as...
The study team makes the final eligibility decision.
Where it's taking place
- West Valley City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Valley City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.