A Phase 1 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
Summary
This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.
Detailed description
This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer. The entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion. Phase 1 dose escalation of INV-9956 follows a real time monitored, PK/PD and safety guided scheme with a traditional 3+3 design for DLT assessment. Phase 2 aims to reassure the safety profile and better define efficacy. Phase 2 consists of up to 2 cohorts by different AR gene status: * Cohort A: AR mutant CRPC * Cohort B: AR wide-type CRPC (optional) Currently enrolling patients under Phase 2.
Arms & interventions
- DrugINV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Outcome measures
Primary
Phase 1: Maximum tolerated dose (MTD)
The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.
Time frame: Within first 28 days of treatment
Phase 1: Recommended dose range (RDR)
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
Time frame: 12 months
Phase 2: Evaluate Radiographic progression-free survival (rPFS)
To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
Time frame: 12 months
Phase 2: Evaluate overall response rate (ORR)
To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
Time frame: 12 months
Secondary
Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0
Time frame: 12 months
Phase 1: Determine the PK using AUC of INV-9956
Time frame: 12 months
Phase 1: Determine the PK using Cmax of INV-9956
Time frame: 12 months
Phase 1: Determine the blood concentration of steroid hormone
Time frame: 12 months
Phase 1: Evaluate Radiographic progression-free survival (rPFS)
Time frame: 12 months
Phase 1: Evaluate overall response rate (ORR)
Time frame: 12 months
Phase 2: Characterize the safety of INV-9956 as assessed by CTCAE v5.0
Time frame: 12 months
Phase 2: Determine the PK using AUC of INV-9956
Time frame: 12 months
Phase 2: Determine the PK using Cmax of INV-9956
Time frame: 12 months
Phase 2: Determine the blood concentration of steroid hormone
Time frame: 12 months
Eligibility criteria
Study locations (7)
Honor Health
Scottsdale, Arizona, 85258
Hoag Family Cancer Institute
Newport Beach, California, 92663
UC Irvine Medical Center
Orange, California, 92868
Next Oncology - Houston
Houston, Texas, 77054
UT Health
San Antonio, Texas, 78229
NEXT Oncology
Fairfax, Virginia, 22031
Summit Cancer Centers
Spokane, Washington, 99208