Study of LP-184 for Advanced Solid Tumors
This study is testing a new drug called LP-184 for people with advanced solid tumors that have not responded to standard treatments or for which no standard treatment is available. LP-184 works by damaging cancer cell DNA, which can lead to cancer cell death. The main goals of this study are to find out how safe LP-184 is, what side effects it might cause, and to determine the highest dose that can be given safely. Researchers will also look at how the body handles LP-184 and if it shows any signs of shrinking tumors. You would receive LP-184 through an IV infusion on specific days during 21-day cycles.
- Study design
- This is an interventional study with a planned enrollment of 64 participants. It is designed to find the safest and most effective dose of LP-184.
- What's involved
- You would receive LP-184 infusions on Day 1 and Day 8 of each 21-day cycle, for at least two cycles. You will be monitored for safety, how your body processes the drug, and its effects on your cancer.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and tolerability will be assessed for 12 months. The recommended dose for future studies will also be determined within 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05933265
Study of LP-184 in Patients With Advanced Solid Tumors
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentLantern Pharma Inc.
~64 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:LP-184OlaparibNivolumab & Ipilimumab
At a glance
Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the safety and tolerability of LP-184 assessed by the incidence and severity of all adverse events graded by CTCAE v5.0
Measured over 12 months
+2 more outcomes measured
Conditions
Where it's being run
7 sites across 7 statesArkansas1
Indiana1
Kentucky1
Maryland1
Pennsylvania1
Texas1
Utah1
Study leadership
- Reggie Ewesuedo, MD · STUDY_DIRECTOR · Lantern Pharma Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
AST, ALT ≤3 x ULN or \<5 x ULN in cases of documented liver metastases or involvement of liver in the disease process.
Total serum bilirubin ≤1.5 x ULN or \<5 x ULN if secondary to Gilbert's syndrome or documented liver metastases or involvement of liver in the disease process.
Serum creatinine clearance ≥60 mL/min either measured or calculated using standard Cockcroft-Gault formula.
Serum electrolyte (potassium, calcium, and magnesium) levels within the normal reference range (may be supplemented according to institutional standard).
ANC ≥1500/μL.
Hemoglobin ≥8 g/dL (The use of transfusion or other intervention to achieve hemoglobin ≥8 g/dL is acceptable. For those patients undergoing RBC transfusion, hemoglobin must be evaluated at least 14 days after the last RBC transfusion).
Platelet count ≥100,000/μL (assessed ≥7 days following last platelet transfusion in patients with thrombocytopenia requiring platelets).
has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy;
is age ≥60 years and is amenorrhoeic; or
is age \<60 years and has been amenorrhoeic for ≥12 months (including no irregular menses or spotting) in the absence of any medication which induces a menopausal state and has documented ovarian failure by serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range). 9. WOCBP or must agree to use highly effective contraceptive methods and avoid egg donation during the study treatment and for 6 months after the last dose of LP-184. 10. Men of reproductive potential agree to use highly effective contraceptive methods and avoid sperm donation during the study treatment and for 3 months after the last dose of LP-184. A man is of child-producing potential unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. 11. Is willing to provide archived samples (blocks and/or slides) for comprehensive DDR genomic analyses and/or PTGR1 expression profiling and/or other genomic alterations if the patient has a PR/CR. 12. Regarding brain metastases, based on screening contrast brain MRI, patients must have 1of the following:
No evidence of brain metastases
Untreated brain metastases not requiring immediate local therapy. For patients with untreated CNS lesions \>2.0 cm on screening contrast brain MRI, discussion with and approval from the Medical Monitor is required prior to enrollment.
Previously treated brain metastases that are either stable for at least 4 weeks since last treatment or progressed since prior local CNS therapy and not requiring immediate re-treatment with local therapy in the opinion of the investigator.
Exclusion
New York Heart Association Class IV heart failure.
Myocardial infarction or stroke ≤3 months prior to the first dose of LP-184.
Unstable angina within ≤12 weeks prior to the first dose of LP-184 unless the underlying disease has been corrected by procedural intervention e.g., stent, bypass.
Severe aortic stenosis.
Uncontrolled arrhythmia. Sponsor approval of patients with arrhythmia is required.
QTc \>470 ms by Fredericia criteria.
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 Cycle 1 Day 1 (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. 8. 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). 9. Have had major surgery (requiring general anesthesia) within ≤4 weeks of first dose of LP-184. 10. Have any other serious medical condition which, in the opinion of the investigator, would preclude the patient from study participation. 11. Have clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids at a dose \> 2 mg of dexamethasone or equivalent or anticonvulsants to control associated symptoms. Patients with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 4 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (1 week for stereotactic radiotherapy). 12. For patients with suspected or known CNS metastatic disease, based on screening brain MRI, patients must not have:
What this trial measures
- To evaluate the safety and tolerability of LP-184 assessed by the incidence and severity of all adverse events graded by CTCAE v5.012 months
- To determine the MTD of LP-184 based on all available safety (graded by CTCAE v5.0) and PK data.12 months
- To determine the RP2D of LP-184 based on all available safety (graded by CTCAE v5.0), PK, PD and efficacy data12 months