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LP-184, an acylfulvene, for PTGR1-Positive, DNA repair deficient, urothelial carcinoma
EU CTIS ID: 2026-525808-94-00
What this study is testing
Phase Ib: To characterize the safety and tolerability of LP-184. Phase ll: To evaluate the antitumor activity in terms of objective response in patients treated with LP-184.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provide signed written ICF and voluntary consent pri-or to any mandatory study specific procedures, sam-pling, and analyses.
- At least one line of prior systemic treatment (if ineligi-ble to standard 2nd line treatment patients can be con-sidered for inclusion)
- At least 4 weeks post major surgery or radiotherapy. Limited field radiotherapy with short duration for symptom control is allowed until 2 weeks before C1D1
- Adequate organ function at screening defined as: 1) Liver Function: AST*, ALT* ≤3 × ULN or <5 × ULN in cases of documented liver metastases or involvement of the liver in the disease process. Total serum bilirubin* ≤1.5 × ULN or <5 × ULN if secondary to Gilbert’s Syn-drome or documented liver metastases or involvement of the liver in the disease process. 2) Renal Function: Serum creatinine clearance ≥45 mL/min either measured or calculated using the standard Cockcroft-Gault formula. 3) Bone Marroe Function: ANC* ≥1,5 × 10⁹/L. o Hemoglobin* ≥5,0 mmol/L (The use of transfusion or other intervention to achieve hemoglobin ≥5,0 mmol/L is ac-ceptable. For those patients undergoing RBC transfusion, hemoglobin must be evaluated at least 14 days after the last RBC transfusion). Platelet count* ≥100 × 10⁹/L (assessed ≥7 days following last platelet transfusion in patients with thrombocytopenia requir-ing platelets). 4) Blood clotting function: INR* and aPTT* ≤1.5 × ULN. Patients on therapeutic doses of anticoagulation medication must have INR and/or aPTT ≤ the upper limit of the therapeutic range for the intended use.
- Women of childbearing potential (WOCBP) must have a nega-tive serum pregnancy test within 3 days of the first dose of LP-184. A woman is of childbearing potential unless she: 1) • has had a hysterectomy, bilateral tubal ligation, or bi-lateral oophorectomy. 2) is aged ≥60 years and is amenorrhoeic. 3) is aged <60 years and has been amenorrhoeic for ≥12 months (including no irregular menses or spotting) in the absence of any medication which induces a men-opausal state and has documented ovarian failure by serum estradiol and follicle-stimulating hormone.
- Women of childbearing potential must use highly effective contraception as defined in Section 7.6 and Appendix B.
You likely can't join if
- Exposure to anti-cancer therapy within 2 weeks or within at least 5 half-lives of the anti-cancer agent whichever is shorter; or 4 weeks from any biologics/immunotherapies or any investigational therapy prior to the first dose of LP-184. (Note: low-dose steroids (oral prednisone or equivalent ≤20 mg/day), localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone-releasing hormone agonists for prostate cancer, and treatment with bisphosphonates and RANKL inhibitors are not criteria for exclusion if such therapy has not been changed within 4 weeks be-fore LP-184 treatment.)
- Any history of retinopathy and/or macular degeneration (without specifications or grades).
- Infection requiring antibiotics, antivirals, or antifungals within 1 week prior to first dose of study drug. Prophy-lactic therapy for e.g. urinary tract infections allowed.
- Hepatitis B and/or hepatitis C infection (determined on baseline hepatitis B and C screen) or known seroposi-tivity for or history of active viral infection with human immunodeficiency virus (HIV).
- Have clinically significant cardiac disease including: 1) New York Heart Association Class IV heart failure. 2) Myocardial infarction or stroke ≤3 months prior to the first dose of LP-184. 3) 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. 4) Severe aortic stenosis. 5) Uncontrolled arrhythmia. 6) QTc >470 milliseconds by Fredericia criteria. 7) Congenital long QT syndrome, or a QTcF interval >470 ms (average of triplicate ECGs) at screening and on Cycle 1 Day 1 (pre-dose) except for a documented bundle branch block or unless sec-ondary to a pacemaker.
- 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 spon-sor. Patients with chronic Grade 2 toxicities may be el-igible per the discretion of the investigator e.g., Grade 2 chemotherapy-induced neuropathy, alopecia, or hypo-thyroidism from prior immunotherapy treatment).
See the full eligibility criteria
Who can join
- Provide signed written ICF and voluntary consent pri-or to any mandatory study specific procedures, sam-pling, and analyses.
- At least one line of prior systemic treatment (if ineligi-ble to standard 2nd line treatment patients can be con-sidered for inclusion)
- At least 4 weeks post major surgery or radiotherapy. Limited field radiotherapy with short duration for symptom control is allowed until 2 weeks before C1D1
- Adequate organ function at screening defined as: 1) Liver Function: AST*, ALT* ≤3 × ULN or <5 × ULN in cases of documented liver metastases or involvement of the liver in the disease process. Total serum bilirubin* ≤1.5 × ULN or <5 × ULN if secondary to Gilbert’s Syn-drome or documented liver metastases or involvement of the liver in the disease process. 2) Renal Function: Serum creatinine clearance ≥45 mL/min either measured or calculated using the standard Cockcroft-Gault formula. 3) Bone Marroe Function: ANC* ≥1,5 × 10⁹/L. o Hemoglobin* ≥5,0 mmol/L (The use of transfusion or other intervention to achieve hemoglobin ≥5,0 mmol/L is ac-ceptable. For those patients undergoing RBC transfusion, hemoglobin must be evaluated at least 14 days after the last RBC transfusion). Platelet count* ≥100 × 10⁹/L (assessed ≥7 days following last platelet transfusion in patients with thrombocytopenia requir-ing platelets). 4) Blood clotting function: INR* and aPTT* ≤1.5 × ULN. Patients on therapeutic doses of anticoagulation medication must have INR and/or aPTT ≤ the upper limit of the therapeutic range for the intended use.
- Women of childbearing potential (WOCBP) must have a nega-tive serum pregnancy test within 3 days of the first dose of LP-184. A woman is of childbearing potential unless she: 1) • has had a hysterectomy, bilateral tubal ligation, or bi-lateral oophorectomy. 2) is aged ≥60 years and is amenorrhoeic. 3) is aged <60 years and has been amenorrhoeic for ≥12 months (including no irregular menses or spotting) in the absence of any medication which induces a men-opausal state and has documented ovarian failure by serum estradiol and follicle-stimulating hormone.
- Women of childbearing potential must use highly effective contraception as defined in Section 7.6 and Appendix B.
- Men of reproductive potential must agree to use highly effec-tive 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.
- Regarding brain metastases, based on one of the following: 1) No clinical evidence of brain metastases. 2) Previously treated brain metastases that are either sta-ble for at least 4 weeks since last treatment or pro-gressed since prior local CNS therapy and not requiring immediate re-treatment with local therapy. 3) Patients on a chronic stable dose of ≤2 mg total daily of dexamethasone (or equivalent) are eligible.
- Histologically confirmed progressive, advanced (T4b, N+ or M1) urothelial carcinoma (UC)
- Measurable disease by RECIST 1.1
- DDR deficiency by local test
- PTGR1 overexpression as defined by local test
- ECOG performance status 0-1 (appendix A)
- Minimum age of 18 years
- Life expectancy > 3 months
- No prior treatment with acylfulvens
What rules you out
- Exposure to anti-cancer therapy within 2 weeks or within at least 5 half-lives of the anti-cancer agent whichever is shorter; or 4 weeks from any biologics/immunotherapies or any investigational therapy prior to the first dose of LP-184. (Note: low-dose steroids (oral prednisone or equivalent ≤20 mg/day), localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone-releasing hormone agonists for prostate cancer, and treatment with bisphosphonates and RANKL inhibitors are not criteria for exclusion if such therapy has not been changed within 4 weeks be-fore LP-184 treatment.)
- Any history of retinopathy and/or macular degeneration (without specifications or grades).
- Infection requiring antibiotics, antivirals, or antifungals within 1 week prior to first dose of study drug. Prophy-lactic therapy for e.g. urinary tract infections allowed.
- Hepatitis B and/or hepatitis C infection (determined on baseline hepatitis B and C screen) or known seroposi-tivity for or history of active viral infection with human immunodeficiency virus (HIV).
- Have clinically significant cardiac disease including: 1) New York Heart Association Class IV heart failure. 2) Myocardial infarction or stroke ≤3 months prior to the first dose of LP-184. 3) 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. 4) Severe aortic stenosis. 5) Uncontrolled arrhythmia. 6) QTc >470 milliseconds by Fredericia criteria. 7) Congenital long QT syndrome, or a QTcF interval >470 ms (average of triplicate ECGs) at screening and on Cycle 1 Day 1 (pre-dose) except for a documented bundle branch block or unless sec-ondary to a pacemaker.
- 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 spon-sor. Patients with chronic Grade 2 toxicities may be el-igible per the discretion of the investigator e.g., Grade 2 chemotherapy-induced neuropathy, alopecia, or hypo-thyroidism from prior immunotherapy treatment).
- Have any other serious medical condition which, in the opinion of the investigator, would preclude the patient from study participation.
- Pregnant or breastfeeding women, or women of childbearing potential unwilling or unable to comply with contraception requirements outlined in Section 7.6.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.