Clinical trials: Androgen Receptor Positive
PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC).
- Trial name
- NCT07311694
- Testing
- HRS-4357 injection, Enzalutamide；Abiraterone
- Where
- China
- Volunteers
- 370 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Metastatic Breast Cancer
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
This study is a multi-center, open-label, dose-esclation I/Ib clinical study to explore safety, efficacy an pharmacokinetics of proxalutamide in patients with metastatic breast cancer.
- Trial name
- NCT04103853
- Testing
- Proxalutamide
- Where
- 7 sites in China
- Volunteers
- 63 people
- Sponsor
- Suzhou Kintor Pharmaceutical Inc,
HER2 Amplified, Advanced Breast Cancer
A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.
- Conditions
- HER2 Amplified, Advanced Breast Cancer, Human Epidermal Growth Factor Receptor 2 (HER2)
- Trial name
- NCT02091960
- Testing
- Enzalutamide, Trastuzumab
- Where
- 39 sites in United States, Belgium and 4 more
- Volunteers
- 103 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Castration-resistant Prostate Cancer
The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor…
- Trial name
- NCT06520345
- Testing
- 177Lu-TLX591, Enzalutamide, Abiraterone
- Where
- 33 sites in United States, Australia and 4 more
- Volunteers
- 520 people
- Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer
The purpose of this study is to evaluate the efficacy of [177Lu]Lu-PSMA-617 over a change of androgen receptor-directed therapy (ARDT) treatment in prolonging radiographic progression free survival (rPFS) in Chinese metastatic…
- Trial name
- NCT05658003
- Testing
- [177Lu]Lu-PSMA-617, ARDT, [68Ga]Ga-PSMA-11
- Where
- 15 sites in China
- Volunteers
- 63 people
- Sponsor
- Novartis Pharmaceuticals
Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor…
- Trial name
- NCT01889238
- Testing
- Enzalutamide
- Where
- 132 sites in United States, Belgium and 5 more
- Volunteers
- 118 people
- Sponsor
- Pfizer
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC
The purpose of this study was to assess the efficacy, safety, tolerability, Pharmacokinetic(s) (PK) and dosimetry of [177Lu]Lu-PSMA-617 when administered in addition to Best Supportive/Best Standard of Care (BSC/BSoC) in Chinese…
- Trial name
- NCT05670106
- Testing
- [177Lu]Lu-PSMA-617, Best supportive/best standard of care (BS/BSOC), 68Ga-PSMA-11
- Where
- 17 sites in China
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasm
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium [177Lu] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive…
- Trial name
- PSMACare (NCT05849298)
- Testing
- AAA617, AAA517, Piflufolastat F 18
- Where
- 31 sites in United States, Brazil and 9 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Prostate Cancer
Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer
The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with…
- Trial name
- NCT02130700
- Testing
- VT-464: given orally twice daily in 28-day cycles, VT-464: given orally once daily in 28-day cycles
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Innocrin Pharmaceutical
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
Salivary Gland Neoplasms
A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
The purpose of the study is to evaluate the overall response rate (ORR) of apalutamide in combination with a gonadotropin-releasing hormone (GnRH) agonist in participants with androgen receptor (AR) expressing locally advanced or…
- Trial name
- YATAGARASU (NCT04325828)
- Testing
- Apalutamide, GnRH Agonist
- Where
- 7 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Janssen Pharmaceutical K.K.
Triple Negative Breast Cancer
Efficacy and Safety of GTx-024 in Patients With Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)
The purpose of this study is to determine if GTx-024 is effective and safe in the treatment of patients with advanced, androgen receptor positive triple negative breast cancer (AR+ TNBC).
- Trial name
- NCT02368691
- Testing
- GTx-024
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- GTx
Breast Cancer
To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.
- Trial name
- NCT05673694
- Testing
- EG017
- Where
- 5 sites in China
- Volunteers
- 70 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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
Metastatic Breast Cancer
Phase II Study of GTx024 in Women With Metastatic Breast Cancer
The primary efficacy analysis will be the clinical benefit at 6 months as measured by a modified Response Evaluation Criteria in Solid Tumors RECIST classification.
- Trial name
- NCT01616758
- Testing
- GTx-024 9mg
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- GTx