A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Purpose

This is a Phase 1 and Phase 2 study to determine the safety profile, RDR and/or MTD, DLT, PK/PD, and preliminary antitumor activity of INV-9956 in adult patients with advanced mCRPC.

Condition

  • Advanced Metastatic Castration Resistant Prostate Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts 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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1 INV-9956 Dose escalation Dose level 1 		INV-9956 Dose escalation Dose level 1 is co-administered with dexamethasone and fludrocortisone acetate
  • Drug: INV-9956
    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Experimental
Phase 1 INV-9956 Dose escalation Dose level 2 		INV-9956 Dose escalation Dose level 2 is co-administered with dexamethasone and fludrocortisone acetate
  • Drug: INV-9956
    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Experimental
Phase 1 INV-9956 Dose escalation Dose level 3 		INV-9956 Dose escalation Dose level 3 is co-administered with dexamethasone and fludrocortisone acetate
  • Drug: INV-9956
    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Experimental
Phase 2 INV-9956 Dose expansion - Cohort A 		INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
  • Drug: INV-9956
    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Experimental
Phase 2 INV-9956 Dose expansion - Cohort B 		INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
  • Drug: INV-9956
    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Experimental
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
  • Drug: INV-9956
    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Experimental
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
  • Drug: INV-9956
    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Experimental
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
  • Drug: INV-9956
    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate

Recruiting Locations

UT Health
San Antonio, Texas 78229
Contact:
Epp Goodwin
210-450-5798
goodwine@uthscsa.edu

More Details

Status
Recruiting
Sponsor
Shenzhen Ionova Life Sciences Co., Ltd.

Study Contact

Yi Zhu, MD, MBA
1 908 240 7514
yi.zhu@ionovabio.com

Detailed Description

This is a Phase 1 and Phase 2 study to determine the safety profile, RDR and/or MTD, DLT, PK/PD, and preliminary antitumor activity of INV-9956 in adult patients with advanced mCRPC. 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.