INV-9956 for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.
Must be taking: GnRH analogue
Disqualifiers: Crohn's, Diabetes, Cardiac disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, ongoing androgen deprivation therapy is required, so you should continue that treatment.
What safety data exists for INV-9956 (enzalutamide) in humans?
How does the drug INV-9956 differ from other prostate cancer treatments?
The drug INV-9956 is unique because it may involve a novel mechanism or approach not detailed in the available research, as there is no direct information about it. However, similar treatments like insulin potentiation therapy (IPT) combined with low-dose chemotherapy have shown promise in managing castration-resistant prostate cancer with minimal side effects, suggesting that INV-9956 might also offer a new way to treat this condition.678910
Eligibility Criteria
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.Inclusion Criteria
INR ≤1.5
I've had taxane chemotherapy and hormonal therapy for my cancer.
Has a life expectancy of >3 months
See 9 more
Exclusion Criteria
Clinically significant abnormality in serum potassium and sodium
My diabetes is not well-managed.
I do not have any active or unstable heart or brain blood vessel problems.
See 6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Stage 1 involves dose escalation to determine the maximum tolerated dose (MTD) and recommended dose range (RDR) of INV-9956, co-administered with dexamethasone and fludrocortisone acetate.
4 weeks
Multiple visits for dose escalation and monitoring
Dose Expansion
Stage 2 involves dose expansion to further assess the safety, tolerability, and preliminary antitumor activity of INV-9956 at the determined dose levels.
12 months
Regular visits for treatment and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of radiographic progression-free survival and overall response rate.
12 months
Treatment Details
Interventions
- INV-9956 (Cancer Vaccine)
Trial OverviewINV-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.
Participant Groups
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NEXT OncologySan Antonio, TX
NEXT OncologyFairfax, VA
Honor HealthScottsdale, AZ
Hoag Family Cancer InstituteNewport Beach, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Shenzhen Ionova Life Sciences Co., Ltd.Lead Sponsor
References
Expression of Androgen Receptor Variant 7 (AR-V7) in Circulated Tumor Cells and Correlation with Drug Resistance of Prostate Cancer Cells. [2021]BACKGROUND Prostate cancer is a common type of malignant tumor invading the male reproductive-urinary system, which has increasing incidence worldwide. Androgen receptor variant 7 (AR-V7) participates in regulating prostate cancer cell proliferation and gene expression. This study aimed to investigate the expression of AR-V7 in circulated tumor cells (CTCs) in patients with prostate cancer and to assess its correlation with drug sensitivity against enzalutamide or abiraterone. MATERIAL AND METHODS Blood samples of prostate cancer patients were collected for separating CTCs, in which mRNA expression level of full-length AR and AR-V7 was measured to analyze their correlation with enzalutamide or abiraterone resistance. Progression-free survival (PFS) of patients with different AR-V7 expression levels was compared. AR-V7 was overexpressed in transfected prostate cancer cells, and its effects on proliferation were analyzed by clonal formation assay. RESULTS qRT-PCR showed AR-V7 overexpression in a total of 13 patients; 76.92% of these patients developed drug resistance, the distal metastasis of which was significantly higher than that in the group with AR-V7 downregulation, with lower PFS (p
Enzalutamide in patients with non-metastatic castration-resistant prostate cancer after combined androgen blockade for recurrence following radical treatment in Japan (Japanese research for patients with non-metastatic castration-resistant prostate cancer-enzalutamide: JCASTRE-zero)-a prospective single-arm interventional study. [2022]The effect of enzalutamide in patients with non-metastatic castration-resistant prostate cancer after combined androgen blockade, which represents a patient profile similar to real-world clinical practice in Japan, remains unknown. Therefore, we investigate the efficacy and safety of enzalutamide after combined androgen blockade for recurrence following radical treatment in Japanese patients with non-metastatic castration-resistant prostate cancer.
Enzalutamide-induced severe thrombocytopenia complicated by a seizure in a 76-year-old man with castration-resistant prostate cancer. [2022]Adverse events with enzalutamide widely used for men with castration-resistant prostate cancer are of interest.
Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial. [2021]In the PROSPER trial, enzalutamide significantly improved metastasis-free survival in patients with non-metastatic, castration-resistant prostate cancer. Here, we report the results of patient-reported outcomes of this study.
Does castration status affect docetaxel-related adverse events? :Identification of risk factors for docetaxel-related adverse events in metastatic prostate cancer. [2022]Docetaxel-related adverse events (AEs) such as neutropenia and febrile neutropenia (FN) can be life-threatening. A previous in vivo study raised the hypothesis that the castration status affects the rate of hematologic AEs. We aimed to investigate the impact of castration status on the incidence of docetaxel-related AE in metastatic prostate cancer (mPCa) patients.
Low-dose chemotherapy with insulin (insulin potentiation therapy) in combination with hormone therapy for treatment of castration-resistant prostate cancer. [2021]Purpose. To evaluate the results and quality of life of patients with resistant of castration-resistant tumors previously treated with Insulin-potentiation therapy (IPT) combined with hormone therapy. Materials and methods. Sixteen patients with metastasis prostate tumors after bilateral castration, androgenic blockade, and progression of the disease were observed during the study. The patients were divided into two groups: group A consisting of 8 patients treated with low-dose chemotherapy Epirubicin, Vinblastine, and Cyclophosphamide combined with LHRH agonist and group B consisting of another 8 patients treated with low-dose chemotherapy Docetaxel combined with LHRH agonist. Results. The overall (groups A and B) results concerning PSA after the sixth IPT show partial effect in 8 out of 16 (50%) patients, stabilization in 4 out of 16 (25%), and progression in 4 out of 16 (25%). The median survival for all treated patients is 11,7 months (range 3-30 months). During the treatment no significant side effects were observed, and no lethal cases occurred. Conclusion. In spite of the small number of the treated patients with castration-resistant prostate tumors, the preliminary results are promising and this gives us hope and expectations for future serious multicenter research over the possibilities for routine implementation of IPTLD.
Plain language summary: Can declines in prostate-specific antigen level indicate how long patients with advanced prostate cancer will live when treated with enzalutamide? [2023]Label="WHAT IS THIS SUMMARY ABOUT?" NlmCategory="UNASSIGNED">This is a summary of a research article originally published in the Journal of Urology. The PROSPER study involved men who had a type of advanced prostate cancer called non-metastatic castration-resistant prostate cancer (nmCRPC). In patients with nmCRPC, their prostate cancer keeps growing even after traditional hormone treatments. In these patients, rising prostate-specific antigen (PSA) levels suggest that cancer is active but CT and bone scans show that it has not spread to other parts of the body. Everyone in this study received androgen deprivation therapy (ADT) either with the medicine enzalutamide or a placebo. Enzalutamide is a medicine that can slow or stop androgens, such as testosterone, from making prostate cancer grow. The main results of the PROSPER study showed that patients with nmCRPC treated with enzalutamide and ADT lived longer than patients treated with placebo and ADT. In this study, researchers wanted to know if the findings were different depending on how much patients' PSA level declined after enzalutamide treatment. Researchers also wanted to know if this made a difference in how long patients lived without the cancer spreading to other parts of their body.
First-line use of novel hormonal agents in prostate cancer: a critical appraisal. [2018]Castration has been the hallmark of the treatment of advanced prostate cancer for nearly a century. Conventional surgical or medical castration for the management of metastatic prostate cancer has been associated with an initial response rate greater than 60% to 70%, depending on the criteria employed. The median duration of the initial response is usually less than 3 to 5 years, however, depending on the extent of disease. The failure of disease to respond to castration has been associated with an increase in the production of adrenal androgens and/or the evolution of upregulated or mutated androgen receptors. Second-line hormonal treatment with adrenal inhibitors is sometimes used, but remissions usually last for less than a year. Extensive translational research has produced a series of second-line, multitargeted, hormonally active agents that inhibit androgen receptor function and/or multiple sites within the hypothalamic/pituitary/end-organ axis. Abiraterone and enzalutamide have been shown to be active in second-line or subsequent hormonal therapy for castration-resistant prostate cancer, and recent data have shown a substantial anticancer effect in initial therapy. The potential use of abiraterone and enzalutamide as initial therapy for advanced prostate cancer is the focus of this brief review, which emphasizes that new approaches should not become the standard of care until they have been validated in randomized trials. In addition, it remains unclear whether first-line treatment with chemohormones or new-generation hormones should be the current standard for all patients with newly diagnosed metastatic prostate cancer.
Phase II trial of a new biological response modifier (ImuVert) in advanced prostate cancer. [2019]ImuVert, a new biological response modifier of bacterial origin, was evaluated in a Phase II trial of patients with metastatic prostate cancer. Sixteen patients with hormone refractory measurable or evaluable disease were treated with ImuVert 1.0 mg subcutaneously once weekly for 5 weeks. After a 1 week rest period, the dose was escalated to 3.0 mg weekly for 5 additional weeks. Eleven patients received the full 10 weeks of therapy. Toxicity consisted of mild transient flu-like symptoms as well as the development of tenderness and induration at injection sites. No patient responded to treatment. ImuVert at this dose and schedule is inactive in advanced prostate cancer.
Clinical and immunologic impact of short-course enzalutamide alone and with immunotherapy in non-metastatic castration sensitive prostate cancer. [2021]The standard treatment for non-metastatic castration sensitive prostate cancer (nmCSPC) is androgen deprivation therapy (ADT) or surveillance. This study evaluated the potential synergy of immunotherapy and enzalutamide (without ADT) in nmCSPC. In addition, the immunologic impact of enzalutamide was also evaluated in men with normal testosterone.