Abstract 2427
Background
Prostate cancer is the most common malignant tumor in men and is the second leading cause of cancer-related deaths in men. Recently there are several 2nd generations of anti-androgen therapies approved and used widely in clinics. However, many patients (pts) relapse after a period of treatment in clinic due to various resistant mechanisms and require new drug or additional therapy. GT0918 is a new chemical entity of androgen receptor (AR) antagonist with more specificity and activity in inhibiting ARs with reduced drug accumulation in the CNS and also show activities on AR mutations including ART878A leading AR drug resistance in cell assays. In early phase I clinical trial of dose escalation study (NCT02826772), GT0918 was shown well tolerated in mCRPC pts progressed lines of standard and experimental therapies with some durable responses. 400mg and 500mg orally once daily were selected warranted for further clinical testing.
Trial design
The study is an open-label, randomized, multicenter, trial to assess GT0918 in mCRPC pts progressed after either abi or enza. The primary object is to evaluate the safety and tolerability of GT0918 either 400 mg or 500 mg daily dose to determine the RP2D for Ph III and/or other confirming studies. The secondary objectives are to evaluate efficacy endpoints including≥ 50% PSA suppression, the percentage of radiographic disease progression, the time to radiographic and bone progression, the time to PSA progression. The key eligibility includes histologically confirmed mCRPC, prior failed therapy either abi or enza (only 1 prior chemotherapy is allowed), progression defined by PCWG 3 criteria, and life expectancy of ≥ 6 months (at screening). 60 pts are enrolled at 12 US sites and randomized in a 1:1 ratio to orally take 400 mg or 500 mg of GT0918 once daily for initial treatment of 6 months. Pts will continue treatment with GT0918 up to 12 months at their assigned dose until disease progression, intolerable toxicities (AEs), or withdrawn consent. The trial started in May 2019. An interim analysis of both safety and efficacy will be performed after 30 pts become evaluable.
Clinical trial identification
NCT03899467 (April 2, 2019).
Editorial acknowledgement
Legal entity responsible for the study
Suzhou Kintor Pharmaceuticals Inc.
Funding
Suzhou Kintor Pharmaceuticals Inc.
Disclosure
N.J. Vogelzang: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Janssen; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Bayer. P. Zhang: Full / Part-time employment: Suzhou Kintor Pharmaceuticals Inc. K. Zhou: Full / Part-time employment: Suzhou Kintor Pharmaceuticals Inc. All other authors have declared no conflicts of interest.
Resources from the same session
2929 - Changes of the Commensal Microbiome during Treatment are Associated with Clinical Response in the Nasopharyngeal Carcinoma Patients
Presenter: Tingting Huang
Session: Poster Display session 3
Resources:
Abstract
2888 - Development and validation a nomogram based on pathological microscopic features to predict survival in nasopharyngeal carcinoma and guide treatment decision
Presenter: Kuiyuan Liu
Session: Poster Display session 3
Resources:
Abstract
3607 - Deep learning in nasopharyngeal carcinoma: a retrospective cohort study of 3D convolutional neural networks on magnetic resonance imaging
Presenter: Meng Yun Qiang
Session: Poster Display session 3
Resources:
Abstract
5848 - Combined androgen blockade in patients with advanced androgen receptor–positive salivary gland carcinoma: Exploratory biomarker analyses
Presenter: Chihiro Fushimi
Session: Poster Display session 3
Resources:
Abstract
4484 - Classification of esthesioneuroblastoma (ENB) based on chromosome (chr) arm gain and loss (CNA) in the setting of a hypomutated genomic landscape
Presenter: Russell Madison
Session: Poster Display session 3
Resources:
Abstract
5753 - Trastuzumab plus docetaxel in patients with advanced HER2–positive salivary duct carcinoma: Exploratory biomarker analyses
Presenter: Hideaki Takahashi
Session: Poster Display session 3
Resources:
Abstract
3373 - Development and characterization of salivary gland cancer organoid cultures
Presenter: Wim Boxtel
Session: Poster Display session 3
Resources:
Abstract
3118 - A parent-of-origin effect of the RB1 mutations in retinoblastoma with low penetrance and variable expressivity
Presenter: Ekaterina Alekseeva
Session: Poster Display session 3
Resources:
Abstract
4512 - The humanistic burden reported by patients diagnosed with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) in Europe
Presenter: Prianka Singh
Session: Poster Display session 3
Resources:
Abstract
3961 - Concurrent Chemotherapy and External Radiation Therapy: An Open Label Non-Inferiority Phase III Randomized Controlled Trial of Weekly versus Three Weekly Cisplatin and Radical Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: CONCERT trial
Presenter: ATUL SHARMA
Session: Poster Display session 3
Resources:
Abstract