A Phase 1, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Patients with Advanced Solid Tumors and Subsequent Expansion Cohorts

metastatic castrate resistant prostate cancer

Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): Define the recommended dose and schedule for PT-112 for pivotal studies, administered either as 250 mg/m2 on Days 1 and 15 of each 28- day cycle (Arm 2) or as 360 mg/m2 on Days 1 and 15 of Cycle 1, then 250 mg/m2 on Day 15 of each subsequent 28-day cycle (Arm 3), where the primary endpoint (benefit) is defined as DCR4.

● Disease control rate (DCR) by disease manifestation, ● Objective response rate (ORR) in patients with RECIST-measurable disease, defined as the percentage of patients achieving a confirmed PR and CR, based on tumor assessments by CT with contrast at baseline and after every 2 cycles (8±1 weeks) of treatment through the first 6 months, then every 3 cycles (12±1 weeks), evaluated using PCWG3-modified RECIST criteria;, ● The median duration of response (DOR) for soft tissue (non-bone) lesions, calculated as from the first observation of response to the first observation of disease progression using PCWG3-modified RECIST criteria;, ● Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0);, ● Percentage of patients who have ≥ 3 CTCs at baseline and ≤ 3 CTCs in one or more post-baseline samples (i.e., CTC conversion);, ● Percentage of patients achieving PSA50 defined as ≥ 50% reduction in serum PSA from Cycle 1 Day 1 that is confirmed at the start of a subsequent cycle as defined by PCWG3 criteria;, ● Median radiographic progression-free survival (rPFS), calculated from the start of study drug to the first observation of radiographic disease progression by PCWG3 criteria;, ● Median overall survival (OS);, ● Time to PSA progression by PCWG3 criteria, calculated from the start of study drug to the first observation of PSA progression by PCWG3 criteria;, ● Change in disease-related pain, based on American Cancer Society Daily Pain Diary assessment of worst pain over the past 24 hours (11 point scale) and analgesic consumption, ● Number of treatment-related adverse events (TRAEs) as a measure of safety and tolerability;, ● Determine the pharmacokinetics of PT-112 following dosing on Days 1 and 15 of Cycle 1;, ● Assess exposure-response and exposure-safety relationships for PT-112.

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