Advanced Solid Tumors, CRPC, Genital Neoplasms, Male, mCRPC, Metastatic Castrate-resistant Prostate Cancer, Neoplasms by Site, Prostatic Neoplasms, PT-112, Urogenital Neoplasms
Conditions
Keywords
PT-112
Brief summary
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).
Detailed description
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.
Interventions
DRUGPT-112 Injection
Sponsors
Promontory Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects enrolled in Cohort D Part 2 will be randomized.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male \>/= 18 years of age * Histologically or cytologically confirmed adenocarcinoma of the prostate. * Document current evidence of metastatic castration-resistant prostate cancer (mCRPC), where metastatic status is defined as having documented metastatic lesion(s) on either bone scan or CT/MRI scan. * Patients who have received at least three prior intended life-prolonging therapies for metastatic disease. * Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1. * Progressive disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor marker(s). * Adequate organ function based on laboratory values. * If there is a known history of brain metastases, either treated or untreated, the disease must be stable. Key
Exclusion criteria
* Any cytotoxic chemotherapy within 21 days prior to initiation of study drug. * Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug. * Bone marrow reserve which is not adequate for participation in this trial. * Radiotherapy within 14 days prior to baseline. * Fraction of radiotherapy to \>25 % of active bone marrow. * Major surgery within 28 days prior to initiation of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial design: Comparison of two dose levels, administered on Days 1 and 15 of each 28-day cycle: | 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 |
| Modified design: Define the recommended dose and schedule for PT-112 for pivotal studies | 28-day cycle | Define the recommended dose and schedule for PT-112 for pivotal studies. Cohort D only |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median duration of response (DOR) as defined by PCWG3-modified RECIST criteria | up to 24 months | Cohort D only |
| Percentage of patients achieving PSA50 as defined by PCWG3 criteria | up to 24 months | Cohort D only |
| Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0) | up to 24 months | Cohort D only |
| Percentage of patients who have ≥ 3 CTCs at baseline and ≤ 3 CTCs in one or more post-baseline samples (i.e., CTC conversion) | up to 24 months | Cohort D only |
| Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria | up to 24 months | Cohort D only |
| Median overall survival (OS) | up to 24 months | Cohort D only |
| Time to PSA progression by PCWG3 criteria | up to 24 months | Cohort D only |
| Change in disease related pain based on ACS Daily Pain Diary assessment | up to 24 months | Cohort D only |
| Median radiographic progression free survival (rPFS) by PCWG3 criteria | up to 24 months | Cohort D only |
| Objective Response Rate (ORR) in patients with RECIST-measurable disease, evaluated using PCWG3-modified RECIST criteria | up to 24 months | Cohort D only |
Countries
France, United States
Outcome results
None listed