Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients with Relapsed or Refractory Lymphomas and Solid Tumors
- Conditions
- Advanced Solid TumorRelapsed or Refractory Lymphomas
- Interventions
- Registration Number
- NCT06132503
- Lead Sponsor
- Lantern Pharma Inc.
- 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.
- Detailed Description
This FIH study is an open-label Phase 1a/1b dose escalation and dose expansion study in adult patients with R/R lymphoma and solid tumors. Patients who provide informed consent and meet the eligibility criteria for the study will be enrolled and treated with LP-284 administered intravenously (IV) on Days 1, 8, 15 of a 28-day schedule.
The study will be conducted in 2 parts: dose escalation with MTD and/or RP2D confirmation (Phase 1a) and dose expansion (Phase 1b). Up to 30 evaluable patients will be enrolled in Phase 1a; the total number of patients will depend on the number of dose levels explored. Up to 40 evaluable patients will be enrolled in each of the 2 cohorts of MCL and DLBCL tumors in Phase 1b.
Patients will remain on study treatment for up to a total of one-year OR until disease progression, unacceptable toxicity, withdrawal of consent, any study-specific discontinuation criteria are met, or the Investigator determines that it is in the best interest of the patient to discontinue study treatment, whichever is shorter.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-284 LP-284 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.
- Primary Outcome Measures
Name Time Method Phase 1a: To determine the maximum tolerated dose (MTD). 12 months 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
Phase 1a: To evaluate the safety and tolerability of escalating doses of LP-284 12 months 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
Phase 1a: To determine the recommended Phase 2 dose (RP2D). 12 months 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
Phase 1b: To obtain preliminary estimates of clinical activity of LP-284 5 years 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
- Secondary Outcome Measures
Name Time Method Phase 1b: To evaluate clinical activity endpoints for LP-284 5 years To evaluate duration of response (DOR), progression free survival (PFS) and overall survival (OS) in all in patients with relapsed or refractory DLBCL and MCL. DOR is defined as time of initial response until documented tumor progression, death, or last adequate assessment. PFS is defined as time from treatment initiation to tumor progression, death, or last adequate assessment. OS is defined as time from treatment initiation to death from any cause.
Phase 1b: To characterize the pharmacokinetics (PK) of LP-284 5 years To characterize PK parameters for LP-284 and metabolite(s) derived from plasma concentrations in patients with relapsed or refractory DLBCL and MCL
Phase 1a: To characterize the pharmacokinetics (PK) of LP-284 1 year To characterize PK parameters for LP-284 and metabolite(s) derived from plasma concentrations
Phase 1b: To evaluate the safety and tolerability of LP-284 at the recommended Phase 2 dose(s) (RP2D) 5 years Evaluate the safety and tolerability of LP-284 at the RP2D by measuring the incidence and severity of adverse events (AEs) graded according to NCI CTCAE 5.0, and changes in clinical laboratory parameters, vital signs, and electrocardiograms (ECGs) in patients with relapsed or refractory DLBCL and MCL
Phase 1a: To assess clinical activity of LP-284 1 year To obtain preliminary estimates of clinical activity by examining overall response rate based on Investigator's assessment as per Lugano Criteria and Duration of Response (DOR) for lymphoma; and to determine ORR (based on Investigator's assessment), complete response (CR), partial response (PR), and DOR for solid tumors .
Trial Locations
- Locations (4)
Cancer and Blood Specialists Clinic
🇺🇸Los Alamitos, California, United States
Florida Cancer Specialists
🇺🇸Lake Mary, Florida, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
START Mountain Region
🇺🇸West Valley City, Utah, United States