Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLantern Pharma Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Symptomatic ischemia, or
Trial design
Design model
Single group
Treatments tested in this trial
LP-284
DrugLP-284 is a small molecule alkylating agent causing tumor cell death through DNA damage.
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-284Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 months2
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
Time frame
12 months3
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
Time frame
12 months4
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
Time frame
5 yearsSecondary outcomes
1
Phase 1a: To characterize the pharmacokinetics (PK) of LP-284
To characterize PK parameters for LP-284 and metabolite(s) derived from plasma concentrations
Time frame
1 year2
Phase 1a: To assess clinical activity of LP-284
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 .
Time frame
1 year3
Phase 1b: To evaluate the safety and tolerability of LP-284 at the recommended Phase 2 dose(s) (RP2D)
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
Time frame
5 years4
Phase 1b: To evaluate clinical activity endpoints for LP-284
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.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov