Clinical trials: SBMA, active
Triple Negative Breast Cancer
Ribociclib and Bicalutamide in AR+ TNBC
This is an open label, multi-institutional, single arm phase II trial of ribociclib in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization or blinding is involved.
- Trial name
- NCT03090165
- Testing
- ribociclib, Bicalutamide
- Where
- 6 sites in United States
- Volunteers
- 37 people
- Sponsor
- Kari Wisinski
Prostate Cancer (Adenocarcinoma)
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach…
- Trial name
- TRIPLE-SWITCH (NCT06592924)
- Testing
- Abiraterone, Enzalutamide, Apalutamide
- Where
- 395 sites in United States, Canada and 2 more
- Volunteers
- 830 people
- Sponsor
- Canadian Cancer Trials Group
PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as…
- Trial name
- NCT07226986
- Testing
- AMO959, AAA617, Enzalutamide
- Where
- 25 sites in United States, Australia and 5 more
- Volunteers
- 123 people
- Sponsor
- Novartis Pharmaceuticals
Prostate CA, Prostate Cancer (Adenocarcinoma)
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in…
- Conditions
- Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
- Trial name
- NCT06631521
- Testing
- Darolutamide, Relugolix, Radical Prostatectomy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- AdventHealth
Metastatic Castration-resistant Prostate Cancer
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled.
- Trial name
- PRESERVE-006 (NCT05682443)
- Testing
- ONC-392 low, ONC-392 high, lutetium Lu 177 vipivotide tetraxetan
- Where
- 23 sites in United States
- Volunteers
- 148 people
- Sponsor
- OncoC4, Inc.
Metastatic Castration-resistant Prostate Cancer (CRPC), Metastatic Castration-resistant Prostate Carcinoma
Novel ACK1 Inhibitor (R)-9b in Patients With Prostate Cancer
TITLE: Phase 1 First in Human Trial to Assess Safety and Tolerability of the Novel ACK1 Inhibitor (R)-9bMS in Patients with Prostate Cancer (PHAROS) STUDY DESCRIPTION: Prostate cancer (PC) patients receive androgen deprivation…
- Trial name
- PHAROS (NCT06705686)
- Testing
- (R)-9bMS
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- TechnoGenesys, Inc.
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)
The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received…
- Trial name
- EvoPAR-PR05 (NCT07711002)
- Testing
- Saruparib, Enzalutamide, Darolutamide
- Where
- 210 sites in United States, Austria and 19 more
- Volunteers
- 1,330 people
- Sponsor
- AstraZeneca
Prostate Cancer (Adenocarcinoma), mCRPC (Metastatic Castration-resistant Prostate Cancer)
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate or Darolutamide
The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have…
- Trial name
- TALENT (NCT06844383)
- Testing
- Talazoparib with enzalutamide, Talazoparib
- Where
- 8 sites in United States
- Volunteers
- 126 people
- Sponsor
- Prostate Cancer Clinical Trials Consortium
Prostate Cancer (Diagnosis), Prostate Cancer Stage IV
High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)
In patients with prostate cancer (PC), cardiovascular disease (CVD) causes significant morbidity and is the second leading cause of death.
- Conditions
- Prostate Cancer (Diagnosis), Prostate Cancer Stage IV, CV Risk
- Trial name
- NCT07223385
- Testing
- Cardio-Oncology Referral, Notification to PCP/General Cardiologist
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Cedars-Sinai Medical Center
Fertility Disorders
TRAP Study: Testosterone for Androgen Receptor Polymorphism
To determine whether pretreatment with transdermal testosterone increases the number of cumulus-oocyte complexes (COCs) obtained after ovarian stimulation by more than 1.5 in patients with low ovarian reserve and androgen…
- Trial name
- TRAP (NCT06195163)
- Testing
- Transdermal Gel in Sachet Dosage Form, No pretreatment
- Where
- Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Instituto Bernabeu
Prostate Cancer
Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer
This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy…
- Trial name
- NCT04946370
- Testing
- 225Ac-J591, Pembrolizumab, Androgen receptor inhibitor
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- Weill Medical College of Cornell University
Metastatic Castration Resistant Prostate Cancer (mCRPC)
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
The purpose of this study is to assess safety of combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI and AAA617 alone in PSMA-positive mCRPC patients who were previously treated and…
- Trial name
- PSMAndARPI (NCT06894511)
- Testing
- AAA617, ARPI: Abiraterone, ARPI: Enzalutamide
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Cancer, Castration-Resistant
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617)…
- Trial name
- NCT07047118
- Testing
- JSB462, AAA617
- Where
- 44 sites in United States, Australia and 13 more
- Volunteers
- 138 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic…
- Trial name
- AcTFirst (NCT06855277)
- Testing
- AAA817, ARPI, Standard of Care
- Where
- 106 sites in United States, Australia and 10 more
- Volunteers
- 940 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs
ANDROMEDA is a first-in-human, Phase I/II, open-label, multicenter study of AZD9750 in participants with metastatic prostate cancer.
- Trial name
- ANDROMEDA (NCT07336446)
- Testing
- AZD9750, AZD5305
- Where
- 5 sites in United States, Australia and 2 more
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
Metastatic Prostate Cancer
ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
This is a phase 1 study to assess the safety and tolerability of ARX517 as monotherapy or combination therapy in adult subjects with metastatic prostate cancer (mPC).
- Trial name
- ARX517 (NCT04662580)
- Testing
- ARX517, Apalutamide, Abiraterone acetate
- Where
- 12 sites in United States
- Volunteers
- 183 people
- Sponsor
- Janssen Research & Development, LLC
Prostatic Neoplasms
A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic castration resistant prostate cancer (mCRPC)…
- Trial name
- NCT03523442
- Testing
- Apalutamide
- Where
- 4 sites in China
- Volunteers
- 19 people
- Sponsor
- Janssen Research & Development, LLC
Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care…
- Trial name
- NCT07570979
- Testing
- INR731, Enzalutamide, Abiraterone
- Where
- 13 sites in United States, Australia and 6 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration-Resistant Prostate Cancer, mCRPC
REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult Participants
This study will test an experimental Regeneron drug called REGN21353 ("study drug") to see if it can help treat previously treated prostate cancer that has spread (also called metastatic castration-resistant prostate cancer or…
- Trial name
- NCT07850921
- Testing
- REGN21353, Nezastomig, Sarilumab Prophylaxis (Contingency)
- Volunteers
- 192 people
- Sponsor
- Regeneron Pharmaceuticals
Metastatic Prostate Cancer
Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer
The purpose of this clinical trial is to determine the anti-tumor activity of talazoparib plus enzalutamide as first line treatment for metastatic castration resistant prostate cancer (mCRPC) in participants whose disease has…
- Trial name
- TEAM PC (NCT06582628)
- Testing
- Enzalutamide capsule, Enzalutamide capsule and Talazoparib capsule
- Where
- 19 sites in France, Spain
- Volunteers
- 78 people
- Sponsor
- Fundacion Oncosur