Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors

NCT06132503 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LP-284-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsed or Refractory Lymphomas; Advanced Solid Tumor

Keywords

LP-284; Phase 1a/1b; Lantern Pharma; Cancer; lymphoma; DLBCL; MCL; Sarcoma

Outcome Measures

Primary Outcomes (4)

• Phase 1a: To evaluate the safety and tolerability of escalating doses of LP-284

  Evaluate the safety and tolerability of escalating doses of LP-284 by measuring the incidence and severity of adverse events (AEs) of escalating doses of LP-284 to determine the maximum tolerated dose (MTD) in patients with relapsed or refractory (R/R) lymphomas and solid tumors

  12 months

• Phase 1a: To determine the maximum tolerated dose (MTD).

  Determine the maximum tolerated dose (MTD) of LP-284 by measuring the incidence and severity of adverse events (AEs) graded according to NCI CTCAE 5.0, clinical laboratory, and electrocardiogram (ECG) abnormalities defined as dose-limiting toxicities (DLTs) in patients with relapsed or refractory (R/R) lymphomas and solid tumors

  12 months

• Phase 1a: To determine the recommended Phase 2 dose (RP2D).

  Determine the recommended Phase 2 dose (RP2D) of LP-284 by measuring the incidence and severity of adverse events (AEs) graded according to NCI CTCAE 5.0, clinical laboratory, and electrocardiogram (ECG) abnormalities defined as dose-limiting toxicities (DLTs) in patients with relapsed or refractory (R/R) lymphomas and solid tumors

  12 months

• Phase 1b: To obtain preliminary estimates of clinical activity of LP-284

  To obtain preliminary estimates of clinical activity by examining the overall response rate, based on Investigator's assessment as per Lugano criteria, of LP-284 in adult patients with relapsed/refractory MCL and DLBCL

  5 years

Secondary Outcomes (5)

• Phase 1a: To characterize the pharmacokinetics (PK) of LP-284

  1 year

• Phase 1a: To assess clinical activity of LP-284

  1 year

• Phase 1b: To evaluate the safety and tolerability of LP-284 at the recommended Phase 2 dose(s) (RP2D)

  5 years

• Phase 1b: To evaluate clinical activity endpoints for LP-284

  5 years

• Phase 1b: To characterize the pharmacokinetics (PK) of LP-284

  5 years

Study Arms (1)

Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-284

EXPERIMENTAL

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.

Drug: LP-284

Interventions

LP-284 DRUG

LP-284 is a small molecule alkylating agent causing tumor cell death through DNA damage.

Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-284

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. The lesion must be positive on positron emission tomography (PET) scan.
• Note: Patients without measurable disease per Lugano Classification \[9\] may be eligible for Part 1a, following discussion with the Investigator and the Sponsor, if the patient presents with non-measurable but assessable disease of any size unequivocally attributable to advanced lymphoma.
• 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 lymphoma involvement of liver.
• ii Total serum bilirubin ≤ 1.5 x ULN or \< 5x ULN if secondary to Gilbert's syndrome or documented lymphoma involvement of liver.
• Renal Function iii Serum creatinine clearance ≥60 mL/min, either measured or calculated using standard Cockcroft-Gault formula.
• iv Serum electrolyte (potassium, calcium, and magnesium) levels within the normal reference range (may be supplemented according to institutional standards).
• Bone Marrow Function:
• v Absolute neutrophil count (ANC) ≥ 1500/μL. (Phase 1b: ANC ≥ 1000/μL if documented by investigator as the normal baseline for the patient) vi Hemoglobin ≥ 8 g/dL (for those patients undergoing red blood cell \[RBC\] transfusion, hemoglobin must be evaluated after at least 14 days after the last RBC transfusion).
• vii Platelet count ≥ 100,000/μL (assessed ≥ 7 days following last platelet transfusion in patients with thrombocytopenia requiring platelets). (Phase 1b: ≥ 75,000/μL may be acceptable after discussion with the Sponsor)
• 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.

You may not qualify if:

• 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 treated basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder.
• 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 per the discretion of the investigator and Sponsor (e.g., Grade 2 chemotherapy-induced neuropathy or hypothyroidism from prior immunotherapy treatment)
• 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 branch block will not be excluded), or
• 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 secondary to pacemaker. In the case of a documented bundle branch block or a pacemaker, discussion with the Medical Monitor is required prior to enrollment.
• 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 infection and with clinical improvement). In the case of prophylactic use of these agents, discussion with the Medical Monitor is required prior to enrollment.
• 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 active viral infection with human immunodeficiency virus (HIV).
• 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 safety risk.
• The patient is pregnant or breastfeeding.

Sponsors & Collaborators

• Lantern Pharma Inc.: lead

Study Sites (1)

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma; Neoplasms; Sarcoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Connective and Soft Tissue

Study Officials

• Reggie Ewesuedo, MD

  reggie@lanternpharma.com

  STUDY DIRECTOR

Central Study Contacts

Sandra Sinclair, BSBA, MHA/Ed, RN

CONTACT

832-622-1699; sandra@lanternpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 15, 2023
• Study Start: January 3, 2023
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)