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Phase Ib/II Study of LP-184 in Patients with Advanced or Metastatic Urothelial Carcinoma

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on urothelial carcinoma, a cancer that starts in the lining of the bladder and can spread to other parts of the body. The investigational medicine being tested is called LP-184, an experimental drug designed to work best in tumors that are PTGR1-Positive and have a weakness called DNA repair deficient. The drug is given as a powder that is mixed with liquid and delivered through an intravenous infusion, which means it is administered directly into a vein.

The purpose of the trial is to see whether the medication is safe and can help shrink or stop the growth of the cancer. Participants will receive the infusion in a series of treatment cycles, with regular check‑ups to watch for side effects and to see how the tumor responds. Throughout the study, doctors will monitor health and any changes in the cancer, using simple examinations and scans, to determine if the drug shows a beneficial effect.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After you decide to join the study, you sign an informed consent form that explains the purpose of the trial, possible risks, and what will be required of you.
Your participation is recorded and you become an official study participant.
Step 2
Baseline assessments
The study team collects information about your medical history, performs physical examinations, and takes blood samples to evaluate organ function.
Imaging tests such as scans are performed to document the size and location of your bladder cancer before treatment begins.
Step 3
Starting the study medication
You receive lp-184, a powder that is mixed with a liquid and given as an intravenous infusion (a drip into a vein).
The exact amount of the medication, how often it is given, and the total length of treatment are decided by the investigators based on safety monitoring during the early part of the trial.
Step 4
Treatment cycles and monitoring
Each treatment cycle includes the infusion of lp-184 followed by a period of observation during which blood tests and physical checks are performed to look for side effects.
Additional imaging scans are scheduled at regular intervals to see whether the tumor is responding to the medication.
Step 5
Dose adjustments and safety checks
If side effects are observed, the study doctors may adjust the dose of lp-184 or pause treatment to allow recovery.
All changes are made according to predefined safety rules that aim to protect you.
Step 6
Completion of treatment
Treatment ends after a predetermined number of cycles, or earlier if the disease progresses or unacceptable side effects occur.
You will be informed about the reason for stopping the medication.
Step 7
Post‑treatment follow‑up
After the last infusion, you continue to visit the clinic for follow‑up appointments that include physical exams, blood tests, and imaging to monitor long‑term outcomes such as disease progression and overall survival.

Who can join the trial?

22 criteria

Give a signed written informed consent form (ICF) and agree to take part before any study procedures are done.
Have received at least one previous round of cancer medicine treatment (systemic treatment).
Be at least 4 weeks past any major surgery or radiation therapy (small, symptom‑relief radiation is allowed up to 2 weeks before the first dose).
Show adequate organ health, which means:
- Liver tests (AST and ALT) are no higher than three times the normal limit (or less than five times if cancer has spread to the liver); total bilirubin is no higher than 1.5 times normal (or less than five times if the patient has Gilbert’s syndrome or liver involvement).
- Kidney function measured by serum creatinine clearance is at least 45 mL/min.
- Bone‑marrow function is sufficient: white blood cells called neutrophils (ANC) are at least 1.5 × 10⁹/L, hemoglobin is at least 5.0 mmol/L (blood transfusion is allowed if needed, but hemoglobin must be checked at least 14 days after a transfusion), and platelets are at least 100 × 10⁹/L (checked at least 7 days after any platelet transfusion).
- Blood clotting tests (INR and aPTT) are no higher than 1.5 times the normal limit; if you take blood‑thinning medication, these values must be within the therapeutic range.
- Women who could become pregnant must have a negative pregnancy test done within 3 days before the first dose.
- Women who could become pregnant must use a highly effective birth‑control method during the study.
- Men who could father a child must use a highly effective birth‑control method and must not donate sperm while taking the study drug and for 3 months after the last dose.
- Meet one of the brain‑metastasis conditions:
  - No evidence of cancer in the brain.
  - Previously treated brain metastases that have been stable for at least 4 weeks.
  - Brain metastases that have progressed but do not need immediate local treatment.
  - Being on a stable low dose (≤2 mg per day) of the steroid medication dexamethasone (or equivalent).
  - Have a confirmed diagnosis of advanced urothelial carcinoma (bladder‑related cancer that is progressive, T4b, N+, or M1) based on tissue testing.
  - Have disease that can be measured according to the RECIST 1.1 criteria (standard way doctors track tumor size).
  - Show a deficiency in DNA‑damage‑repair (DDR) based on a local laboratory test.
  - Show over‑expression of the protein PTGR1 as determined by a local test.
  - Have an ECOG performance status of 0 or 1 (meaning you are fully active or restricted only by symptoms of disease).
  - Be at least 18 years old.
  - Have a life expectancy longer than 3 months.
  - Never have been treated before with drugs called acylfulvens.

Who cannot join the trial?

14 criteria

You cannot join the study if you have received any anti‑cancer therapy (such as chemotherapy or targeted drugs) within the last 2 weeks, or within a period equal to at least five times the drug’s half‑life (the time it takes for half of the drug to leave your body), whichever is shorter; you also must not have taken any biologics or immunotherapies or any experimental drug within the last 4 weeks before the first dose of LP‑184.
Any past history of retinopathy (damage to the retina, the light‑sensing part of the eye) or macular degeneration (a condition that affects the central part of the retina) excludes you from the trial.
If you had an infection that required treatment with antibiotics, antivirals or antifungals within one week before the first dose, you cannot participate (preventive treatment for a urinary tract infection is allowed).
Having an active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) (as shown by blood tests) makes you ineligible.
Significant heart problems prevent enrollment, including:
- Severe heart failure classified as New York Heart Association Class IV (the most serious level).
- A heart attack (myocardial infarction) or stroke that occurred within the past 3 months.
- Unstable chest pain (unstable angina) within the past 12 weeks unless it has been fixed with a procedure such as a stent or bypass surgery.
- Severe narrowing of the aortic valve (aortic stenosis).
- An uncontrolled irregular heartbeat (arrhythmia).
- A prolonged heart‑rate interval on an ECG called QTc greater than 470 milliseconds (a measure of how quickly the heart’s electrical system resets).
- Congenital long QT syndrome or a QTc interval over 470 ms at screening or on the first day of treatment, unless it is due to a known block in the heart’s electrical pathway (bundle branch block) or a pacemaker.
- If you still have side effects from previous treatments that have not returned to normal or are worse than mild (graded higher than Grade 1 on the NCI‑CTCAE scale), you cannot join unless the study sponsor specifically approves it. Chronic mild side effects (Grade 2) such as nerve pain (neuropathy), hair loss (alopecia), or low thyroid function (hypothyroidism) may be allowed at the investigator’s discretion.
- Any other serious medical condition that the doctor believes would make participation unsafe will exclude you from the study.
- Pregnant or breastfeeding women, and women who could become pregnant but are unwilling or unable to follow the required birth‑control rules, are not allowed to take part.

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Verified sites

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Rigshospitalet
Verified
Copenhagen, Denmark

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Investigated drugs

LP-184 is an experimental medicine being studied for people with advanced or metastatic bladder cancer. In the trial, the drug is supplied as a powder that is mixed with a liquid and given through an IV (a needle placed into a vein). The study is looking to see if the medicine is safe to use and whether it can help shrink or control the cancer.

What is already known about the treatment

LP-184 - This medication is supplied as a powder that is mixed with liquid and given by intravenous infusion. It is currently an investigational drug being studied in Phase Ib/II clinical trials for safety and effectiveness in patients with advanced or metastatic urothelial (bladder) cancer. LP-184 belongs to the class of antineoplastic agents and works by entering cancer cells and releasing a compound that damages the cells’ DNA, which stops the cells from growing and leads to their death. Its main therapeutic aim is to treat bladder cancer that has spread or cannot be removed by surgery.

Investigated diseases

Malignant neoplasm - It is an abnormal growth of cells that can invade nearby tissues. Over time, the cells multiply uncontrollably, forming a mass that may spread to other parts of the body. The growth can become larger and involve more structures, altering normal organ function. As the disease advances, the mass may infiltrate blood vessels and lymphatics, allowing cells to travel to distant sites. This progressive expansion characterizes the disease course.