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Cancer Vaccine
INV-9956 for Prostate Cancer
Phase 1
Recruiting
Research Sponsored by Shenzhen Ionova Life Sciences Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy
Metastatic disease
Must not have
Poorly controlled diabetes mellitus
Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is the first time INV-9956 is being tested in humans to see how safe it is, what the recommended dose is, and how it affects prostate cancer. The study will focus on
Who is the study for?
This trial is for adult males with advanced metastatic castration-resistant prostate cancer who've had prior chemotherapy and hormonal therapy. They must be able to swallow pills, have a life expectancy over 3 months, and maintain specific health criteria like normal blood clotting and organ function.
What is being tested?
INV-9956 is being tested in this early-phase trial to find the right dose that's safe but effective. Researchers will look at how the body processes it, its safety profile, and any signs of it fighting the cancer.
What are the potential side effects?
Potential side effects are not detailed here as this is a first-in-human study; however, common risks may include reactions at the infusion site, fatigue, nausea, changes in blood counts or chemistry levels affecting organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on hormone therapy for cancer or have had both testicles removed.
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My cancer has spread to other parts of my body.
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I am fully active or can carry out light work.
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I am a man aged 18 or older.
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My prostate cancer diagnosis was confirmed through a tissue examination.
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I can swallow pills.
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My prostate cancer is not responding to hormone therapy and my testosterone levels are low.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My diabetes is not well-managed.
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I do not have any active or unstable heart or brain blood vessel problems.
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I have had issues with my pituitary or adrenal glands.
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I have a condition or infection that makes taking steroids unsafe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD)
Recommended dose range (RDR)
Secondary study objectives
Characterize the safety of INV-9956 as assessed by CTCAE v5.0
Determine the PK using AUC of INV-9956
Determine the PK using Cmax of INV-9956
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Stage 3 INV-9956 Dose escalation beyond the optimal dose - Dose level 6Experimental Treatment1 Intervention
INV-9956 Dose escalation Dose level 6 is co-administered with dexamethasone and fludrocortisone acetate
Group II: Stage 3 INV-9956 Dose escalation beyond the optimal dose - Dose level 5Experimental Treatment1 Intervention
INV-9956 Dose escalation Dose level 5 is co-administered with dexamethasone and fludrocortisone acetate
Group III: Stage 3 INV-9956 Dose escalation beyond the optimal dose - Dose level 4Experimental Treatment1 Intervention
INV-9956 Dose escalation Dose level 4 is co-administered with dexamethasone and fludrocortisone acetate
Group IV: Stage 2 INV-9956 Dose expansion - Dose Level 2Experimental Treatment1 Intervention
INV-9956 Dose expansion Dose Level 2 is co-administered with dexamethasone and fludrocortisone acetate
Group V: Stage 2 INV-9956 Dose expansion - Dose Level 1Experimental Treatment1 Intervention
INV-9956 Dose expansion Dose Level 1 is co-administered with dexamethasone and fludrocortisone acetate
Group VI: Stage 1 INV-9956 Dose escalation Dose level 3Experimental Treatment1 Intervention
INV-9956 Dose escalation Dose level 3 is co-administered with dexamethasone and fludrocortisone acetate
Group VII: Stage 1 INV-9956 Dose escalation Dose level 2Experimental Treatment1 Intervention
INV-9956 Dose escalation Dose level 2 is co-administered with dexamethasone and fludrocortisone acetate
Group VIII: Stage 1 INV-9956 Dose escalation Dose level 1Experimental Treatment1 Intervention
INV-9956 Dose escalation Dose level 1 is co-administered with dexamethasone and fludrocortisone acetate
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Who is running the clinical trial?
Shenzhen Ionova Life Sciences Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
78 Total Patients Enrolled