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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: PT-112 injection | Experimental | Arm 1: PT-112 Injection, administered by intravenous infusion, biweekly 360 mg/m2 |
|
| Arm 2: PT-112 injection | Experimental | Arm 2: PT-112 Injection, administered by intravenous infusion, biweekly 250 mg/m2 |
|
| Arm 3: PT-112 injection | Experimental | Arm 3: PT-112 Injection, administered by intravenous infusion, 360 mg/m2 for two doses, 250 mg/m2 for subsequent doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT-112 Injection | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 28-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria | Cohort D only | up to 24 months |
| Objective Response Rate (ORR) in patients with RECIST-measurable disease, evaluated using PCWG3-modified RECIST criteria |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel D. Karp, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona | Phoenix | Arizona | 85054 | United States | ||
| Tucson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35747193 | Derived | Karp DD, Camidge DR, Infante JR, Ames TD, Price MR, Jimeno J, Bryce AH. Phase I study of PT-112, a novel pyrophosphate-platinum immunogenic cell death inducer, in advanced solid tumours. EClinicalMedicine. 2022 May 27;49:101430. doi: 10.1016/j.eclinm.2022.101430. eCollection 2022 Jul. |
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Subjects enrolled in Cohort D Part 2 will be randomized.
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Cohort D only
| up to 24 months |
| Median duration of response (DOR) as defined by PCWG3-modified RECIST criteria | Cohort D only | up to 24 months |
| Percentage of patients achieving PSA50 as defined by PCWG3 criteria | Cohort D only | 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 | 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 | up to 24 months |
| Median radiographic progression free survival (rPFS) by PCWG3 criteria | Cohort D only | up to 24 months |
| Median overall survival (OS) | Cohort D only | up to 24 months |
| Time to PSA progression by PCWG3 criteria | Cohort D only | up to 24 months |
| Change in disease related pain based on ACS Daily Pain Diary assessment | Cohort D only | up to 24 months |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Duarte | Duarte | California | 91010 | United States |
| Colorado | Aurora | Colorado | 80045 | United States |
| Jacksonville | Jacksonville | Florida | 32224 | United States |
| Orlando | Orlando | Florida | 32806 | United States |
| Indianapolis | Indianapolis | Indiana | 46202 | United States |
| Boston | Boston | Massachusetts | 02215 | United States |
| Minneapolis | Minneapolis | Minnesota | 55426 | United States |
| Rochester | Rochester | Minnesota | 55905 | United States |
| Omaha | Omaha | Nebraska | 68130 | United States |
| Albuquerque | Albuquerque | New Mexico | 87190 | United States |
| Brooklyn | Brooklyn | New York | 11215 | United States |
| New York | New York | New York | 10065 | United States |
| Durham | Durham | North Carolina | 27705 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Seattle | Seattle | Washington | 19024 | United States |
| Besançon | Besançon | France |
| Bordeaux | Bordeaux | France |
| Caen | Caen | France |
| Clermont-Ferrand | Clermont-Ferrand | France |
| Marseille | Marseille | France |
| Nice | Nice | France |
| Paris | Paris | France |
| Rennes | Rennes | France |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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