JJ and DK have non-remunerated roles on Promontory's Scientific Advisory Board. TA and MP are employees of Promontory Therapeutics and are paid by/own equity in Promontory. Promontory in the past has covered meeting and travel expenses for TA, MP, JJ, and DK.
Bryce anderson and associates trial#
Promontory Therapeutics, as the study sponsor, paid for most aspects of the trial outside those billable to patient insurance and provided study drug (all authors). Immunogenic cell death Lung cancer Pharmacokinetics Phase I clinical trials Prostate cancer Small molecule agent. Further development of PT-112 is ongoing, as single-agent and in combination with immune checkpoint inhibition.įunding was provided by Promontory Therapeutics Inc. Given the heterogeneous patient population, subsequent studies will be needed to characterize the risk/benefit ratio in more homogenous settings. Prolonged responses were noted against thymoma and lung cancer, along with radiographic and serum marker improvement in prostate cancer. PT-112 is safe and well-tolerated in a heavily pre-treated population. Radiographic and serum marker reductions were observed among ten patients with metastatic castration resistant prostate cancer, four of whom survived two years or longer. Durable partial responses were induced in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and thymoma. Nine (17%) of the 54 efficacy evaluable patients achieved progression-free survival ≥6 months.
The recommended phase 2 dose was determined to be 360 mg/m 2. Grade 3 events were experienced by 18 patients (27%), with no grade 4-5 events observed. Treatment-related adverse events included fatigue (23 patients, 35%), nausea (16 patients, 24%), and peripheral neuropathy (14 patients, 21%). This study is registered at, number NCT02266745, with the dose-escalation portion of the study closed.īetween July 7th, 2014 and September 18th, 2018, 66 heavily pre-treated patients (median 4 prior lines, IQR 2-6) were enrolled and treated across 11 doses (12-420 mg/m 2). Patients receiving ≥1 dose of PT-112 were included in the safety and pharmacokinetic analyses, with the exploratory efficacy analysis including patients receiving ≥1 dose at 125 mg/m 2. Eligibility criteria included: age ≥18 years, Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1, and disease evaluable by Response Evaluation Criteria in Solid Tumours (RECIST) v1♱ or by informative tumour markers. The primary objective was to assess safety and pharmacokinetics, and to identify a recommended phase 2 dose (RP2D). Patients with progressing, advanced solid tumours received PT-112 intravenously (1 h) on days 1, 8, 15 of a 28-day cycle in an open-label, multi-centre 3 + 3 dose-escalation trial, conducted at four US research sites. This is the first-in-human study of PT-112 monotherapy, exploring its safety and efficacy in a patient population where standard of care therapies were exhausted and novel treatment options are needed. PT-112 also associates with bone (osteotropism), likely driven by its pyrophosphate moiety. PT-112, the first pyrophosphate-platinum conjugate, causes immunogenic cell death in experimental models, leading to recruitment of tumour-infiltrating lymphocytes.
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