A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
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
1 other identifier
interventional
84
2 countries
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2025
Typical duration for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedStudy Start
First participant enrolled
January 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2028
ExpectedDecember 17, 2025
December 1, 2025
1.2 years
September 11, 2024
December 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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
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)
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)
12 months
Secondary Outcomes (10)
Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0
12 months
Phase 1: Determine the PK using AUC of INV-9956
12 months
Phase 1: Determine the PK using Cmax of INV-9956
12 months
Phase 1: Determine the blood concentration of steroid hormone
12 months
Phase 1: Evaluate Radiographic progression-free survival (rPFS)
12 months
- +5 more secondary outcomes
Study Arms (8)
Phase 1 INV-9956 Dose escalation Dose level 1
EXPERIMENTALINV-9956 Dose escalation Dose level 1 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation Dose level 2
EXPERIMENTALINV-9956 Dose escalation Dose level 2 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation Dose level 3
EXPERIMENTALINV-9956 Dose escalation Dose level 3 is co-administered with dexamethasone and fludrocortisone acetate
Phase 2 INV-9956 Dose expansion - Cohort A
EXPERIMENTALINV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Phase 2 INV-9956 Dose expansion - Cohort B
EXPERIMENTALINV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 4
EXPERIMENTALINV-9956 Dose escalation Dose level 4 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 5
EXPERIMENTALINV-9956 Dose escalation Dose level 5 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 6
EXPERIMENTALINV-9956 Dose escalation Dose level 6 is co-administered with dexamethasone and fludrocortisone acetate
Interventions
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Eligibility Criteria
You may qualify if:
- Written informed consent obtained.
- Male aged ≥ 18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Castration resistant prostate cancer with serum testosterone \<50 ng/dL.
- Metastatic disease.
- Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
- Received at least one prior line of taxane-based chemotherapy and at least one line of hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who have refused or were intolerant to taxane-based chemotherapy may be enrolled.
- ECOG performance status 0-1.
- Adequate marrow, liver and kidney function.
- INR ≤1.5.
- Able to swallow study treatment.
- Has a life expectancy of \> 3 months.
You may not qualify if:
- Have a medical condition such as Crohn's disease or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.
- History of pituitary or adrenal dysfunction.
- Poorly controlled diabetes mellitus.
- Clinically significant abnormality in serum potassium and sodium.
- Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
- History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.
- Prolonged QTcF interval.
- Active infection or other medical condition that would make corticosteroid contraindicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Honor Health
Scottsdale, Arizona, 85258, United States
Hoag Family Cancer Institute
Newport Beach, California, 92663, United States
UC Irvine Medical Center
Orange, California, 92868, United States
Next Oncology - Houston
Houston, Texas, 77054, United States
UT Health
San Antonio, Texas, 78229, United States
NEXT Oncology
Fairfax, Virginia, 22031, United States
Summit Cancer Centers
Spokane, Washington, 99208, United States
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
He'nan Cancer Hospital
Zhengzhou, He'Nan, 450000, China
Hu'nan Cancer Hospital
Changsha, Hu'Nan, 410006, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801, China
Shandong Cancer Hospital
Ji'nan, Shandong, 250000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300202, China
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2024
First Posted
September 23, 2024
Study Start
January 23, 2025
Primary Completion
April 17, 2026
Study Completion (Estimated)
January 17, 2028
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share