A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
Advanced Metastatic Castration Resistant Prostate Cancer
Investigational drug(s) / intervention(s)
INV-9956
INV-9956: INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Written informed consent obtained.
2. Male aged ≥ 18 years.
3. Histologically confirmed adenocarcinoma of the prostate.
4. Castration resistant prostate cancer with serum testosterone \<50 ng/dL.
5. Metastatic disease.
6. Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
7. 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.
8. ECOG performance status 0-1.
9. Adequate marrow, liver and kidney function.
10. INR ≤1.5.
11. Able to swallow study treatment.
12. Has a life expectancy of \> 3 months.
Exclusion Criteria:
1. 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.
2. History of pituitary or adrenal dysfunction.
3. Poorly controlled diabetes mellitus.
4. Clinically significant abnormality in serum potassium and sodium.
5. 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.
6. Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
7. History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.
8. Prolonged QTcF interval.
9. Active infection or other medical condition that would make corticosteroid contraindicated.
Primary outcome measure(s)
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)
Trial sites (22)
Facility
City
Region
Status
Honor Health
Scottsdale
Arizona
Recruiting
Hoag Family Cancer Institute
Newport Beach
California
Recruiting
UC Irvine Medical Center
Orange
California
Recruiting
Next Oncology - Houston
Houston
Texas
Recruiting
UT Health
San Antonio
Texas
Recruiting
NEXT Oncology
Fairfax
Virginia
Recruiting
Summit Cancer Centers
Spokane
Washington
Recruiting
Beijing GoBroad Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
Recruiting
The First People's Hospital of Foshan
Foshan
Guangdong
Not Yet Recruiting
He'nan Cancer Hospital
Zhengzhou
He'Nan
Recruiting
Hu'nan Cancer Hospital
Changsha
Hu'Nan
Not Yet Recruiting
Nanjing Drum Tower Hospital
Nanjing
Jiangsu
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Not Yet Recruiting
Liaoning Cancer Hospital
Shenyang
Liaoning
Recruiting
Shandong Cancer Hospital
Ji'nan
Shandong
Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei
Wuhan
Not Yet Recruiting
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
Recruiting
Zhejiang Provincial People's Hospital
Hangzhou
Zhejiang
Not Yet Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Zhejiang
Not Yet Recruiting
More Shenzhen Ionova Life Sciences Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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