This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase is complete and no longer enrolling. The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase, and the Dose Expansion Phase The Dose Escalation Phase and the Dose Expansion Thymoma Cohort are complete and no longer enrolling. The Dose Expansion Phase of the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) is open and enrolling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
Arizona
Phoenix, Arizona, United States
Tucson
Tucson, Arizona, United States
Duarte
Duarte, California, United States
Colorado
Aurora, Colorado, United States
Jacksonville
Jacksonville, Florida, United States
Orlando
Orlando, Florida, United States
Indianapolis
Indianapolis, Indiana, United States
Boston
Boston, Massachusetts, United States
Minneapolis
Minneapolis, Minnesota, United States
Rochester
Rochester, Minnesota, United States
...and 15 more locations
Initial design: Comparison of two dose levels, administered on Days 1 and 15 of each 28-day cycle:
\[ \] Define the recommended dose level for PT-112 for pivotal studies based on the risk/benefit ratio across Arms 1, 2 and 3. Cohort D only
Time frame: 28-day cycle
Modified design: Define the recommended dose and schedule for PT-112 for pivotal studies
Define the recommended dose and schedule for PT-112 for pivotal studies. Cohort D only
Time frame: 28-day cycle
Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria
Cohort D only
Time frame: up to 24 months
Objective Response Rate (ORR) in patients with RECIST-measurable disease, evaluated using PCWG3-modified RECIST criteria
Cohort D only
Time frame: up to 24 months
Median duration of response (DOR) as defined by PCWG3-modified RECIST criteria
Cohort D only
Time frame: up to 24 months
Percentage of patients achieving PSA50 as defined by PCWG3 criteria
Cohort D only
Time frame: up to 24 months
Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0)
Cohort D only
Time frame: up to 24 months
Percentage of patients who have ≥ 3 CTCs at baseline and ≤ 3 CTCs in one or more post-baseline samples (i.e., CTC conversion)
Cohort D only
Time frame: up to 24 months
Median radiographic progression free survival (rPFS) by PCWG3 criteria
Cohort D only
Time frame: up to 24 months
Median overall survival (OS)
Cohort D only
Time frame: up to 24 months
Time to PSA progression by PCWG3 criteria
Cohort D only
Time frame: up to 24 months
Change in disease related pain based on ACS Daily Pain Diary assessment
Cohort D only
Time frame: up to 24 months
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