Study on the Safety and Effects of PT-112 Injection for Advanced Solid Tumors
Sponsor: Promontory Therapeutics Inc.
ClinicalTrials ID:NCT02266745
This clinical trial is testing the safety and effects of a new drug, PT-112, in patients with advanced solid tumors. The study is currently enrolling patients with a specific type of prostate cancer that has spread and is resistant to standard hormone treatments.
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Program Overview
This study is exploring a new treatment called PT-112 for patients with advanced solid tumors. The trial is divided into two parts: the first part determined the safest dose of PT-112, and the second part is currently enrolling patients with metastatic castrate-resistant prostate cancer (mCRPC) to further evaluate the drug's effects. The study aims to understand how the drug behaves in the body and its potential benefits for patients.
Description
This clinical trial is investigating a new drug, PT-112, for treating advanced solid tumors. The study is divided into two phases. The first phase, which is now complete, focused on finding the safest dose of PT-112. The second phase is currently open for patients with a specific type of prostate cancer that has spread and is resistant to hormone treatments. This phase aims to further assess the drug's safety and effectiveness. Participants will receive PT-112 through an IV and will be monitored for any side effects and changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older.
- Diagnosed with prostate cancer that has spread and is resistant to hormone treatments.
- Must have evidence of cancer spread on scans.
- Have received at least three previous treatments aimed at prolonging life.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Show signs of cancer progression either through physical exams, imaging, or tumor markers.
- Have adequate organ function based on lab tests.
- If there is a history of brain metastases, the disease must be stable.
Exclusion Criteria
- Have received chemotherapy within 21 days before starting the study drug.
- Have taken any drugs that affect the immune system, hormone treatments for cancer, or steroids within 14 days before starting the study drug.
- Have inadequate bone marrow reserve for participation.
- Have received radiotherapy within 14 days before starting the study drug.
- Have had radiotherapy to more than 25% of active bone marrow.
- Have had major surgery within 28 days before starting the study drug.
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