Clinical trials: Urogenital Disease
IgA Nephropathy (IgAN)
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
This Phase 3 study will evaluate the safety and efficacy of JADE101 compared with placebo in adults with immunoglobulin A nephropathy (IgAN).
- Trial name
- NCT07902817
- Testing
- JADE101
- Volunteers
- 480 people
- Sponsor
- Jade Biosciences, 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
- 29 sites in United States, Canada and 2 more
- Volunteers
- 390 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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
- 26 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.
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, 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
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
IgA Nephropathy
A Study of JADE101 in Participants With Immunoglobulin A Nephropathy
This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in participants with IgA nephropathy, and the results will contribute to the overall clinical characterization of JADE101 in this patient…
- Trial name
- NCT07541287
- Testing
- JADE101
- Where
- 20 sites in United States, Australia and 3 more
- Volunteers
- 30 people
- Sponsor
- Jade Biosciences, Inc.
Kidney Diseases, Kidney Diseases, Chronic
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN).
- Conditions
- Kidney Diseases, Kidney Diseases, Chronic, Urological Diseases, Glomerulonephritis
- Trial name
- NCT06858319
- Testing
- zigakibart
- Where
- 26 sites in United States, Argentina and 7 more
- Volunteers
- 220 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
Bacterial Infections, Bacterial Infections and Mycoses
Large Algorithm Setting and Validation Study
In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a…
- Conditions
- Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis
- Trial name
- LAVA (NCT07607470)
- Testing
- Nanopath Vaginitis Assay, BD Max™ Vaginal Panel, Cepheid Xpert® Xpress MVP
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Nanopath, Inc
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
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
Bacterial Vaginosis
A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.
- Trial name
- NCT07302035
- Testing
- GenSci142
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
ccRCC, Clear Cell Renal Cell Carcinoma
Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)
The goal of the Lead-in phase of the study is to evaluate the safety, efficacy, pharmacokinetics (PK) and determine recommended dose for expansion (RDE) of NKT2152 in combination with palbociclib (Doublet) and with palbociclib…
- Conditions
- ccRCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasms
- Trial name
- NCT05935748
- Testing
- NKT2152, palbociclib, sasanlimab
- Where
- 8 sites in United States
- Volunteers
- 18 people
- Sponsor
- NiKang Therapeutics, Inc.
Bladder Cancer Cell Transitional, Non-Muscle Invasive Bladder Cancer
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder.
- Conditions
- Bladder Cancer Cell Transitional, Non-Muscle Invasive Bladder Cancer, Bladder Cancer, Urinary Bladder
- Trial name
- NCT03081858
- Testing
- TSD-001
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Lipac Oncology LLC