PT-112 Injection for Advanced Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Daniel D. Karp, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors, including metastatic castrate-resistant prostate cancer, who have limited treatment options. Participants must be in good physical condition (ECOG 0-1), have stable brain metastases if present, and adequate organ function. They can't join if they've had extensive chemotherapy, uncontrolled heart issues, recent major surgery or radiotherapy, active infections or certain previous cancers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and pharmacokinetics
Dose Expansion
Study of PT-112 in patients with thymoma, thymic carcinoma, and metastatic castrate-resistant prostate cancer (mCRPC)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PT-112 Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phosplatin Therapeutics
Lead Sponsor
Promontory Therapeutics Inc.
Lead Sponsor