Study of LP-184 for Patients with Advanced Solid Tumors
Sponsor: Lantern Pharma Inc.
ClinicalTrials ID:NCT05933265
This clinical trial is testing a new drug, LP-184, to see if it is safe and well-tolerated in patients with advanced solid tumors that have not responded to standard treatments or for which no standard treatment is available.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The main goal of this study is to determine if LP-184 is safe and can be tolerated by patients with advanced solid tumors that have either returned after treatment or have not responded to existing treatments. Participants will receive LP-184 through an infusion on Day 1 and Day 8 of each 21-day cycle, for at least two cycles. Researchers will monitor participants for safety, how the drug is processed in the body, and its effects on the cancer.
Description
Participants who meet the study requirements will receive LP-184 at a dose determined by the study group they are placed in. The drug will be given through an infusion on Day 1 and Day 8 of each 21-day cycle, for at least two cycles. The study will monitor participants for safety, how the drug is processed in the body, and its effects on the cancer. The study will start with a small group of patients to find the safest dose, and then more patients will be added to test this dose further. The goal is to find the best dose for future studies.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have signed a consent form agreeing to participate.
- Must have an advanced solid tumor that has returned after treatment or has not responded to standard treatments, or for which no standard treatment is available.
- Must be in good overall health, with a performance status score of 0-1.
- Must have measurable disease according to specific medical criteria.
- Must have a life expectancy of more than 3 months.
- Must have adequate liver, kidney, and bone marrow function as determined by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after.
- Men must agree to use effective birth control during the study and for 3 months after.
- Must be willing to provide previous tumor samples for analysis.
- Must have no evidence of untreated brain metastases or have stable brain metastases that do not require immediate treatment.
Exclusion Criteria
- Have received anti-cancer therapy within 2 weeks or within at least 5 half-lives of the drug, whichever is shorter, or 4 weeks from any biologics or investigational therapy.
- Have a history of eye diseases like retinopathy or macular degeneration.
- Have received radiation within 4 weeks of starting the study, unless the tumor continues to grow after treatment.
- Have an active infection requiring treatment within 1 week before starting the study, unless controlled.
- Have hepatitis B, hepatitis C, or HIV.
- Are pregnant or breastfeeding.
- Have significant heart disease or recent heart attack or stroke.
- Have had major surgery within 4 weeks of starting the study.
- Have untreated or symptomatic brain metastases requiring steroids or anticonvulsants.
- Have any other serious medical condition that would prevent participation in the study.
- Have brain lesions requiring immediate treatment or known leptomeningeal disease.
- Male patients with pregnant partners or who are unwilling to use effective contraception during the study and for 3 months after.
- Female patients of childbearing potential who are unwilling to use effective contraception during the study and for 6 months after.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group | 72758 | Springdale | Arkansas |
| Cancer and Blood Specialty Clinic | 90720 | Los Alamitos | California |
| Northwest Oncology & Hematology | 60008 | Rolling Meadows | Illinois |
| Indiana University Melvin and Bren Simon Cancer Center | 46202 | Indianapolis | Indiana |
| Norton Healthcare, Inc. | 40205 | Louisville | Kentucky |
| John Hopkins - The Sidney Kimmel Comprehensive Cancer Center | 21287 | Baltimore | Maryland |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
| UT Health Science Center San Antonio | 78229 | San Antonio | Texas |
| START Mountain Region | 84119 | West Valley City | Utah |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.