Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refr… (NCT06132503) | Clinical Trial Compass
RecruitingPhase 1
Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors
United States110 participantsStarted 2023-01-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Adequate organ function at Screening and on C1D1 (pre-dose) defined as:
✓. 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.
Exclusion criteria
✕. History or suspicion of central nervous system (CNS) lymphoma or meningeal involvement or central nervous system (CNS) metastases.
What they're measuring
1
Phase 1a: To evaluate the safety and tolerability of escalating doses of LP-284
Timeframe: 12 months
2
Phase 1a: To determine the maximum tolerated dose (MTD).
Timeframe: 12 months
3
Phase 1a: To determine the recommended Phase 2 dose (RP2D).
Timeframe: 12 months
4
Phase 1b: To obtain preliminary estimates of clinical activity of LP-284
. 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:
✕. 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).