Study of LP-184 in Patients With Advanced Solid Tumors (NCT05933265) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of LP-184 in Patients With Advanced Solid Tumors
United States64 participantsStarted 2023-06-09
Plain-language summary
The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available. The secondary objectives are to characterize the PK of LP-184 and its metabolites in plasma and assess clinical activity of LP-184.
Participants will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, PK, and clinical activity
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥18 years of age at the time of consent
✓. Provided signed written ICF and voluntary consent prior to any mandatory study-specific procedures, sampling, and analyses.
✓. Have a histologically or cytologically documented advanced solid tumor that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available.
✓. ECOG performance status 0-1 or Karnofsky performance scale \>60 for GBM patients.
✓. Patients must have measurable disease per RECIST 1.1 or RANO 2.0 criteria as applicable.
✓. Patients must have life expectancy \>3 months.
✓. Adequate organ function at screening defined as:
✓. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 3 days of first dose of LP-184. A woman is of child-bearing potential unless she:
Exclusion criteria
✕. Exposure to anti-cancer therapy within 2 weeks or within at least 5 half-lives of the anticancer agent whichever is shorter; or 4 weeks from any biologics/immunotherapies or any investigational therapy prior to the first dose of LP-184.
What they're measuring
1
To evaluate the safety and tolerability of LP-184 assessed by the incidence and severity of all adverse events graded by CTCAE v5.0
Timeframe: 12 months
2
To determine the MTD of LP-184 based on all available safety (graded by CTCAE v5.0) and PK data.
Timeframe: 12 months
3
To determine the RP2D of LP-184 based on all available safety (graded by CTCAE v5.0), PK, PD and efficacy data
✕. Any history of retinopathy and/or macular degeneration (without specifications or grades).
✕. Has received radiation within 4 weeks of Cycle 1 Day 1. Unless the tumor at the site of treatment continues to increase in size after the patient has completed radiotherapy treatment.
✕. 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).
✕. Are pregnant or breastfeeding. (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
✕. Have clinically significant cardiac disease including:
✕. Have 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, alopecia, or hypothyroidism from prior immunotherapy treatment).