A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
NCT ID: NCT06609005
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
84 participants
INTERVENTIONAL
2025-01-23
2028-01-17
Brief Summary
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Detailed Description
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The entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion. The screening period for all phases is up to 28 days, and one treatment cycle is 28 days.
The investigational drug will be co-administered with once daily (QD) dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg as corticosteroid replacement therapy.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 INV-9956 Dose escalation Dose level 1
INV-9956 Dose escalation Dose level 1 is co-administered with dexamethasone and fludrocortisone acetate
INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation Dose level 2
INV-9956 Dose escalation Dose level 2 is co-administered with dexamethasone and fludrocortisone acetate
INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation Dose level 3
INV-9956 Dose escalation Dose level 3 is co-administered with dexamethasone and fludrocortisone acetate
INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Phase 2 INV-9956 Dose expansion - Cohort A
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Phase 2 INV-9956 Dose expansion - Cohort B
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 4
INV-9956 Dose escalation Dose level 4 is co-administered with dexamethasone and fludrocortisone acetate
INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 5
INV-9956 Dose escalation Dose level 5 is co-administered with dexamethasone and fludrocortisone acetate
INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 6
INV-9956 Dose escalation Dose level 6 is co-administered with dexamethasone and fludrocortisone acetate
INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Interventions
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INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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Shenzhen Ionova Life Sciences Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Honor Health
Scottsdale, Arizona, United States
Hoag Family Cancer Institute
Newport Beach, California, United States
UC Irvine Medical Center
Orange, California, United States
Next Oncology - Houston
Houston, Texas, United States
UT Health
San Antonio, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Summit Cancer Centers
Spokane, Washington, United States
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
He'nan Cancer Hospital
Zhengzhou, He'Nan, China
Hu'nan Cancer Hospital
Changsha, Hu'Nan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shandong Cancer Hospital
Ji'nan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Andrea House
Role: primary
Patrice Jones
Role: primary
Hazel Dimasuay
Role: primary
Paige Day
Role: primary
Epp Goodwin
Role: primary
Blake Patterson
Role: primary
Monika Chaudhry
Role: primary
Ning Xu
Role: primary
Tiejun Yang
Role: primary
Xingjiang Hu
Role: backup
Shusuan Jiang
Role: primary
Hongqian Guo
Role: primary
Yu Zeng
Role: primary
Yuping Sun
Role: primary
Jiasheng Bian
Role: backup
Jian Zhang
Role: primary
Xin Yao
Role: primary
Peng Zhao
Role: primary
Dahong Zhang
Role: primary
Other Identifiers
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INV-9956-101
Identifier Type: -
Identifier Source: org_study_id