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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Honor Health
Scottsdale, Arizona, United States
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
Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0
To analyze the safety profile of INV-9956 as a single agent by AE, clinical lab test results, ECG and Vital signs changes
Time frame: 12 months
Phase 1: Determine the PK using AUC of INV-9956
To determine the pharmacokinetics (PK) using AUC of INV-9956 after a single dose and at steady state after multiple doses
Time frame: 12 months
Phase 1: Determine the PK using Cmax of INV-9956
To determine the pharmacokinetics (PK) using Cmax of INV-9956 after a single dose and at steady state after multiple doses
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Hoag Family Cancer Institute
Newport Beach, California, United States
RECRUITINGUC Irvine Medical Center
Orange, California, United States
RECRUITINGNext Oncology - Houston
Houston, Texas, United States
RECRUITINGUT Health
San Antonio, Texas, United States
RECRUITINGNEXT Oncology
Fairfax, Virginia, United States
RECRUITINGSummit Cancer Centers
Spokane, Washington, United States
RECRUITINGBeijing GoBroad Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGThe First People's Hospital of Foshan
Foshan, Guangdong, China
NOT_YET_RECRUITING...and 12 more locations
Time frame: 12 months
Phase 1: Determine the blood concentration of steroid hormone
To determine the blood concentration of steroid hormones at various timepoints as PD markers for INV-9956
Time frame: 12 months
Phase 1: 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 1: 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
Phase 2: Characterize the safety of INV-9956 as assessed by CTCAE v5.0
To analyze the safety profile of INV-9956 as a single agent by AE, clinical lab test results, ECG and Vital signs changes
Time frame: 12 months
Phase 2: Determine the PK using AUC of INV-9956
To determine the pharmacokinetics (PK) using AUC of INV-9956 after a single dose and at steady state after multiple doses
Time frame: 12 months
Phase 2: Determine the PK using Cmax of INV-9956
To determine the pharmacokinetics (PK) using Cmax of INV-9956 after a single dose and at steady state after multiple doses
Time frame: 12 months
Phase 2: Determine the blood concentration of steroid hormone
To determine the blood concentration of steroid hormones at various timepoints as PD markers for INV-9956
Time frame: 12 months