INV-9956 for Advanced Metastatic Castration Resistant Prostate Cancer
This study is testing a new targeted therapy called INV-9956 for men with advanced metastatic castration-resistant prostate cancer (prostate cancer that has spread and is no longer responding to treatments that lower testosterone). You would receive INV-9956 along with dexamethasone and fludrocortisone acetate. The study aims to understand how safe INV-9956 is, how your body handles it, and if it can help shrink or slow the growth of your cancer. Researchers are looking for the best dose and how long patients live without their cancer getting worse. The study is currently enrolling patients in Phase 2.
- Study design
- This study has two parts: Phase 1 to find the right dose, and Phase 2 to further check safety and effectiveness. It plans to enroll 84 adult men.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will evaluate how long patients live without their cancer getting worse for up to 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
At a glance
Conditions
Where it's being run
22 sites across 18 statesWho to contact
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What this trial measures
- Phase 1: Maximum tolerated dose (MTD)Within first 28 days of treatment
The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.
- Phase 1: Recommended dose range (RDR)12 months
The RDR will be determined based on the PK and PD data, the preliminary clinical activity of INV-9956, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1
- Phase 2: Evaluate Radiographic progression-free survival (rPFS)12 months
To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
- Phase 2: Evaluate overall response rate (ORR)12 months
To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)