A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INV-9956.
- Who it may be relevant to
- Registry conditions: Advanced Metastatic Castration Resistant Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
Overview
This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.
Detailed description
This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.
The entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion.
Phase 1 dose escalation of INV-9956 follows a real time monitored, PK/PD and safety guided scheme with a traditional 3+3 design for DLT assessment.
Phase 2 aims to reassure the safety profile and better define efficacy. Phase 2 consists of up to 2 cohorts by different AR gene status:
* Cohort A: AR mutant CRPC * Cohort B: AR wide-type CRPC (optional) Currently enrolling patients under Phase 2.
Interventions
- Drug INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Primary outcome measures
- Phase 1: Maximum tolerated dose (MTD) [Time frame: Within first 28 days of treatment]
- Phase 1: Recommended dose range (RDR) [Time frame: 12 months]
- Phase 2: Evaluate Radiographic progression-free survival (rPFS) [Time frame: 12 months]
- Phase 2: Evaluate overall response rate (ORR) [Time frame: 12 months]
Secondary outcome measures (10)
- Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0 [Time frame: 12 months]
- Phase 1: Determine the PK using AUC of INV-9956 [Time frame: 12 months]
- Phase 1: Determine the PK using Cmax of INV-9956 [Time frame: 12 months]
- Phase 1: Determine the blood concentration of steroid hormone [Time frame: 12 months]
- Phase 1: Evaluate Radiographic progression-free survival (rPFS) [Time frame: 12 months]
- Phase 1: Evaluate overall response rate (ORR) [Time frame: 12 months]
- Phase 2: Characterize the safety of INV-9956 as assessed by CTCAE v5.0 [Time frame: 12 months]
- Phase 2: Determine the PK using AUC of INV-9956 [Time frame: 12 months]
- Phase 2: Determine the PK using Cmax of INV-9956 [Time frame: 12 months]
- Phase 2: Determine the blood concentration of steroid hormone [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Written informed consent obtained.
- Male aged ≥ 18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Castration resistant prostate cancer with serum testosterone <50 ng/dL.
- Metastatic disease.
- Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
- 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.
- ECOG performance status 0-1.
- Adequate marrow, liver and kidney function.
- INR ≤1.5.
- Able to swallow study treatment.
- Has a life expectancy of > 3 months.
Exclusion criteria
- 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.
- History of pituitary or adrenal dysfunction.
- Poorly controlled diabetes mellitus.
- Clinically significant abnormality in serum potassium and sodium.
- 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.
- Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
- History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.
- Prolonged QTcF interval.
- Active infection or other medical condition that would make corticosteroid contraindicated.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 15 centers
- Beijing GoBroad Hospital — Beijing
- The First Affiliated Hospital of Fujian Medical University — Fuzhou
- The First People's Hospital of Foshan — Foshan
- He'nan Cancer Hospital — Zhengzhou
- Hu'nan Cancer Hospital — Changsha
- Nanjing Drum Tower Hospital — Nanjing
- The First Affiliated Hospital of Nanchang University — Nanchang
- Liaoning Cancer Hospital — Shenyang
- … and 7 more centers
United States · 7 centers
- Honor Health — Scottsdale
- Hoag Family Cancer Institute — Newport Beach
- UC Irvine Medical Center — Orange
- Next Oncology - Houston — Houston
- UT Health — San Antonio
- NEXT Oncology — Fairfax
- Summit Cancer Centers — Spokane
Identifiers
NCT: NCT06609005 · INV-9956-101