Clinical trials: Urogenital Neoplasms
Hormone-refractory Prostate Cancer
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
There are many treatment options for men with various stages of prostate cancer. Some treatments work well for a while but can cause medical problems in some men. Also, the cancer may come back after treatment.
- Trial name
- NCT05997615
- Testing
- VIR-5500, Androgen receptor signaling inhibitor (ARSI), Docetaxel
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 347 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer Patients
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer.
- Conditions
- Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer Patients, Metastatic Castration-resistant Prostate Cancer, mCRPC, mCRPC
- Trial name
- STRIKE-001 (NCT07103018)
- Testing
- KTX-2001, KTX-2001 + Darolutamide (NUBEQA®)
- Where
- 13 sites in United States
- Volunteers
- 144 people
- Sponsor
- K36 Therapeutics, Inc.
Urothelial Cancer, Urinary Bladder Neoplasms
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer.
- Trial name
- NCT07566156
- Testing
- Enfortumab vedotin, Conventional Radiotherapy, Hypofractionated Radiotherapy
- Where
- 26 sites in United States, Canada and 2 more
- Volunteers
- 390 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Cervical Cancer
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells.
- Trial name
- NCT06952660
- Testing
- TIVDAK
- Where
- 132 sites in United States, Puerto Rico
- Volunteers
- 100 people
- Sponsor
- Pfizer
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
ACCEL is a multicenter, open label phase Ia/Ib/II study of [Ac-225]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Oligometastatic Prostate Carcinoma, Hormone Sensitive Prostate Cancer
- Trial name
- ACCEL (NCT06229366)
- Testing
- [Ac-225]-PSMA-62 (mCRPC), [Ac-225]-PSMA-62 (OmHSPC)
- Where
- 7 sites in Canada
- Volunteers
- 142 people
- Sponsor
- Eli Lilly and Company
Prostate Cancer, mCRPC
A Phase 3 Study of [177Lu]Ludotadipep for Metastatic Castration-Resistant Prostate Cancer
Primary Efficacy Endpoint Radiographic Progression-Free Survival (rPFS): rPFS is defined as the time from randomization to radiographic disease progression (PD), as assessed by Blinded Independent Central Review (BICR) according…
- Trial name
- NCT07853209
- Testing
- [177-Lu]Ludotadipep, Best supportive care/standard of care (BSC/SOC) alone
- Where
- 8 sites in South Korea
- Volunteers
- 114 people
- Sponsor
- FutureChem
Urothelial Carcinoma, Urothelial Carcinoma Recurrent
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.
- Conditions
- Urothelial Carcinoma, Urothelial Carcinoma Recurrent, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent
- Trial name
- uTRACT (NCT05874921)
- Testing
- Jelmyto (mitomycin) for pyelocalyceal solution
- Where
- 22 sites in United States
- Volunteers
- 450 people
- Sponsor
- UroGen Pharma Ltd.
Metastatic Prostate Cancer
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.
- Trial name
- NCT06800313
- Testing
- JNJ-101556143 Formulation 1, JNJ-101556143 Formulation 2, JNJ-101556143 Formulation 3
- Where
- 18 sites in United States, United Kingdom
- Volunteers
- 190 people
- Sponsor
- Janssen Research & Development, LLC
Prostate Cancer Metastatic
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
This first-in-human, Phase 1/2, open-label study evaluates the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of JSB462 (luxdegalutamide, previously ARV-766) administered as monotherapy and in…
- Trial name
- NCT05067140
- Testing
- ARV-766, Abiraterone, Corticosteroid (e.g., prednisone/prednisolone)
- Where
- 17 sites in United States
- Volunteers
- 164 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumors, Genital Neoplasm, Female
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants…
- Conditions
- Advanced Solid Tumors, Genital Neoplasm, Female, Urogenital Neoplasms, Lung Neoplasm
- Trial name
- START-001 (NCT05592626)
- Testing
- STAR0602, Irinotecan (Camptosar), Docetaxel (Taxotere)
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 366 people
- Sponsor
- Marengo Therapeutics, Inc.
Advanced Solid Tumors, Breast Cancer
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
This is a Phase 1, open-label study to evaluate the safety and tolerability of ATV-1601 administered orally in adults with AKT1 E17K-mutant, advanced solid tumors and also in HR+/HER2- advanced and metastatic breast cancer, with…
- Conditions
- Advanced Solid Tumors, Breast Cancer, Breast Carcinoma, Breast Neoplasms
- Trial name
- NCT07038369
- Testing
- ATV-1601, ATV-1601 + Fulvestrant
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 134 people
- Sponsor
- Atavistik Bio, Inc
Prostatic Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs
- Trial name
- CYCLONE 3 (NCT05288166)
- Testing
- Abemaciclib, Abiraterone, Prednisone or Prednisolone
- Where
- 266 sites in United States, Argentina and 22 more
- Volunteers
- 925 people
- Sponsor
- Eli Lilly and Company
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, mCRPC, Urogenital Neoplasms
- Trial name
- NCT05413850
- Testing
- Lutetium (177Lu) rhPSMA-10.1 Injection, 18F-rhPSMA-7.3 injection (in phase 1 only)
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 82 people
- Sponsor
- Blue Earth Therapeutics Ltd
Prostatic Neoplasms, Castration-Resistant
Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer
This is a Phase 1, open-label, international, dose escalation study to evaluate the safety of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) in men with PSMA-positive prostate cancer who have and have not had prior exposure to…
- Trial name
- NCT04597411
- Testing
- 225^Ac-PSMA-617, 68^Ga-PSMA-11
- Where
- 2 sites in Australia, South Africa
- Volunteers
- 101 people
- Sponsor
- Endocyte
mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Diseases, Male
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.
- Conditions
- mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Diseases, Male, Urogenital Diseases, Male, Prostatic Disease
- Trial name
- NCT06190899
- Testing
- Gedatolisib, Darolutamide
- Where
- 13 sites in United States, France and 2 more
- Volunteers
- 54 people
- Sponsor
- Celcuity Inc
Head and Neck Cancers, Breast Cancer
Feasibility Study of CBCT for IGRT in Cancer Patients
Cone beam computed tomography (CBCT) is an imaging technology that is incorporated into many modern radiation therapy systems. The quality of conventional CBCT is good enough to align patients for their daily radiation therapy…
- Conditions
- Head and Neck Cancers, Breast Cancer, Thoracic Cancers, Liver Cancer
- Trial name
- NCT06681233
- Testing
- Comparison of HyperSight CBCT imaging to conventional CBCT imaging.
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Varian, a Siemens Healthineers Company
Advanced Prostate Cancer, GnRH Antagonist
A Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Patients With Advanced Prostate Cancer
The purpose of this clinical trial is to test the effectiveness of a dosing regimen of Teverelix DP castration rate defined as the cumulative probability of testosterone suppression to < 0.5 ng/mL with the lower bound of the 95%…
- Trial name
- NCT07457164
- Testing
- Teverelix DP 180 mg
- Volunteers
- 40 people
- Sponsor
- Antev Ltd.
Human Papillomavirus (HPV), Cervical Intraepithelial Neoplasia
Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer
The purpose of this study is to validate Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, a point-of-care screening and triage diagnostic tool for cervical cancer based on the…
- Conditions
- Human Papillomavirus (HPV), Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms, Cervical Cancers
- Trial name
- OPTICS (NCT06815939)
- Testing
- HPV Test, EVA System, Visual Inspection with Acetic Acid (VIA)
- Where
- El Salvador
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- DL Analytics
Urogenital Neoplasms
Expanded Access to NanoDoce
NanOlogy may consider offering expanded access to NanoDoce for patients who do not meet the enrollment criteria of clinical trials in progress.
- Trial name
- NCT04060628
- Testing
- NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension
- Sponsor
- NanOlogy, LLC
HNSCC, Melanoma
Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors
The subject of this study is the adoptive transfer of selected autologous tumor infiltrating lymphocytes (TIL) after in vitro expansion for the treatment of solid tumor malignancies.
- Conditions
- HNSCC, Melanoma, Gynecologic Cancer, Colorectal Cancer
- Trial name
- ACT (NCT05902520)
- Testing
- DP CD8 TIL, DP CD8 TIL KD, Low dose IL-2
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- AgonOx, Inc.