Trial Title:
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
Condition:
Advanced Metastatic Castration Resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
mCRPC
Prostate Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
INV-9956
Description:
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Arm group label:
Stage 1 INV-9956 Dose escalation Dose level 1
Arm group label:
Stage 1 INV-9956 Dose escalation Dose level 2
Arm group label:
Stage 1 INV-9956 Dose escalation Dose level 3
Arm group label:
Stage 2 INV-9956 Dose expansion - Dose Level 1
Arm group label:
Stage 2 INV-9956 Dose expansion - Dose Level 2
Arm group label:
Stage 3 INV-9956 Dose escalation beyond the optimal dose - Dose level 4
Arm group label:
Stage 3 INV-9956 Dose escalation beyond the optimal dose - Dose level 5
Arm group label:
Stage 3 INV-9956 Dose escalation beyond the optimal dose - Dose level 6
Summary:
This is a Phase 1a, first-in-human, open-label dose-escalation study to determine the RDR
and/or MTD, and to assess the DLT of INV-9956. The safety, tolerability, PK/PD, and
preliminary antitumor activity of INV-9956 will be assessed in adult patients with
advanced mCRPC.
Detailed description:
This is a Phase 1a, first-in-human, open-label dose-escalation study to determine the RDR
and/or MTD, and to assess the DLT of INV-9956. The safety, tolerability, PK/PD, and
preliminary antitumor activity of INV-9956 will be assessed in adult patients with
advanced mCRPC. The study will be conducted in 3 stages: Stage 1: dose escalation; Stage
2: dose expansion; Stage 3 (optional): Dose escalation beyond the optimal dose.
The total number of patients enrolled will depend upon the number of dose-escalation
cohorts and the number of doses evaluated in Stage 2.
The investigational drug will be co-administered with dexamethasone and fludrocortisone
acetate as corticosteroid replacement therapy.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Honor Health
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Andrea House
Phone ext:
480-323-1791
Email:
clinicaltrials@honorhealth.com
Investigator:
Last name:
Michael Gordon, MD
Email:
Principal Investigator
Facility:
Name:
Hoag Family Cancer Institute
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Patrice Jones
Phone:
949-764-5501
Email:
clinicaltrials.@hoag.org
Investigator:
Last name:
David Benjamin, MD
Email:
Principal Investigator
Facility:
Name:
UT Health
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Epp Goodwin
Phone:
210-450-5798
Email:
goodwine@uthscsa.edu
Investigator:
Last name:
John Sarantopoulos, MD
Email:
Principal Investigator
Facility:
Name:
NEXT Oncology
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Blake Patterson
Phone:
703-783-4505
Email:
bpatterson@nextoncology.com
Investigator:
Last name:
Mohamed Salkeni, MD
Email:
Principal Investigator
Start date:
October 17, 2024
Completion date:
March 17, 2027
Lead sponsor:
Agency:
Shenzhen Ionova Life Sciences Co., Ltd.
Agency class:
Industry
Source:
Shenzhen Ionova Life Sciences Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06609005
