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with GT0918 up to 12 months at their assigned dose until disease progression, intolerable toxicities (AEs), or withdrawn consent.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
4370 - Continental differences in pathologic response with neoadjuvant ipilimumab (IPI) plus nivolumab (NIVO) in patients with macroscopic stage III melanoma in the phase 2 OpACIN-neo trial.
Presenter: Irene Reijers
Session: Poster Display session 3
Resources:
Abstract
3230 - Comparable responses of melanoma at primary site and synchronous lymph node metastases upon neoadjuvant ipilimumab (IPI) and nivolumab (NIVO)
Presenter: Judith Versluis
Session: Poster Display session 3
Resources:
Abstract
3171 - Adjuvant Therapies for Stage III Melanoma: Benchmarks for Bringing Clinical Trials to Clinical Practice
Presenter: Tina HIEKEN
Session: Poster Display session 3
Resources:
Abstract
3493 - Mixture-cure modeling for resected stage III/IV melanoma in the phase 3 CheckMate 238 trial
Presenter: Jeffrey Weber
Session: Poster Display session 3
Resources:
Abstract
3036 - An open-label, non-randomized, phase IIIb study of trametinib in combination with dabrafenib for patients with unresectable advanced BRAFV600-mutant melanoma: a subgroup analysis of patients with brain metastasis
Presenter: Caroline Dutriaux
Session: Poster Display session 3
Resources:
Abstract
2233 - Adverse event (AE) kinetics in patients (pts) treated with dabrafenib + trametinib (D + T) in the metastatic and adjuvant setting
Presenter: Jean Jacques Grob
Session: Poster Display session 3
Resources:
Abstract
2435 - A Single Arm, Open Label, Phase II, Multicenter Study to Assess the Detection of the BRAF V600 Mutation on cfDNA from Plasma in Patients with Advanced Melanoma
Presenter: Piotr Rutkowski
Session: Poster Display session 3
Resources:
Abstract
1766 - Efficacy and Safety of Dabrafenib and Trametinib in Patients with Metastatic BRAFV600 Mutation-positive Melanoma in the Real-World Setting – Interim results of the non-interventional COMBI-r study
Presenter: Carola Berking
Session: Poster Display session 3
Resources:
Abstract
2131 - Trial update: A randomized Phase Ib/II study of the selective small molecule Axl inhibitor Bemcentinib (BGB324) in combination with either dabrafenib/trametinib (D/T) or pembrolizumab in patients with metastatic melanoma
Presenter: Oddbjørn Straume
Session: Poster Display session 3
Resources:
Abstract
4074 - Analysis of pyrexia in patients (pts) treated with dabrafenib (D) and/or trametinib (T) across clinical trials
Presenter: Caroline Robert
Session: Poster Display session 3
Resources:
Abstract