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

June 2, 2026 updated by: Shenzhen Ionova Life Sciences Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Not yet recruiting
        • Beijing GoBroad Hospital
        • Contact:
        • Principal Investigator:
          • Chuanliang Cui, MD
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Principal Investigator:
          • Ning Xu
    • Guangdong
      • Foshan, Guangdong, China
        • Not yet recruiting
        • The First People's Hospital of Foshan
        • Contact:
        • Principal Investigator:
          • Rong Huang
    • He'Nan
      • Zhengzhou, He'Nan, China, 450000
        • Recruiting
        • He'nan Cancer Hospital
        • Principal Investigator:
          • Tiejun Yang
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xingjiang Hu
    • Hu'Nan
      • Changsha, Hu'Nan, China, 410006
        • Not yet recruiting
        • Hu'nan Cancer Hospital
        • Principal Investigator:
          • Shusuan Jiang
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Principal Investigator:
          • Hongqian Guo
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Cheng Zhang
          • Phone Number: +86-13607080357
    • Liaoning
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yu Zeng
    • Shandong
      • Ji'nan, Shandong, China, 250000
        • Recruiting
        • Shandong Cancer Hospital
        • Principal Investigator:
          • Yuping Sun
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jiasheng Bian
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Jian Zhang
        • Principal Investigator:
          • Dingwei Ye
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300202
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Principal Investigator:
          • Xin Yao
        • Contact:
    • Wuhan
      • Hubei, Wuhan, China
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Xiaoping Zhang, MD, PhD
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
        • Principal Investigator:
          • Dahong Zhang
        • Contact:
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • the First Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:
        • Principal Investigator:
          • Peng Zhao
      • Wenzhou, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Principal Investigator:
          • Wei Chen
        • Contact:
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Family Cancer Institute
        • Principal Investigator:
          • David Benjamin, MD
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Medical Center
        • Principal Investigator:
          • Edward Uchio, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • Next Oncology - Houston
        • Contact:
        • Principal Investigator:
          • Peter DeMaria, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health
        • Principal Investigator:
          • John Sarantopoulos, MD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology
        • Contact:
        • Principal Investigator:
          • Mohamed Salkeni, MD
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Summit Cancer Centers
        • Principal Investigator:
          • Arvind Chaudhry, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Maximum tolerated dose (MTD)
Time Frame: Within first 28 days of treatment
The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.
Within first 28 days of treatment
Phase 1: Recommended dose range (RDR)
Time Frame: 12 months
The RDR will be determined based on the PK and PD data, the preliminary clinical activity of INV-9956, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1
12 months
Phase 2: Evaluate Radiographic progression-free survival (rPFS)
Time Frame: 12 months
To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
12 months
Phase 2: Evaluate overall response rate (ORR)
Time Frame: 12 months
To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0
Time Frame: 12 months
To analyze the safety profile of INV-9956 as a single agent by AE, clinical lab test results, ECG and Vital signs changes
12 months
Phase 1: Determine the PK using AUC of INV-9956
Time Frame: 12 months
To determine the pharmacokinetics (PK) using AUC of INV-9956 after a single dose and at steady state after multiple doses
12 months
Phase 1: Determine the PK using Cmax of INV-9956
Time Frame: 12 months
To determine the pharmacokinetics (PK) using Cmax of INV-9956 after a single dose and at steady state after multiple doses
12 months
Phase 1: Determine the blood concentration of steroid hormone
Time Frame: 12 months
To determine the blood concentration of steroid hormones at various timepoints as PD markers for INV-9956
12 months
Phase 1: Evaluate Radiographic progression-free survival (rPFS)
Time Frame: 12 months
To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
12 months
Phase 1: Evaluate overall response rate (ORR)
Time Frame: 12 months
To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
12 months
Phase 2: Characterize the safety of INV-9956 as assessed by CTCAE v5.0
Time Frame: 12 months
To analyze the safety profile of INV-9956 as a single agent by AE, clinical lab test results, ECG and Vital signs changes
12 months
Phase 2: Determine the PK using AUC of INV-9956
Time Frame: 12 months
To determine the pharmacokinetics (PK) using AUC of INV-9956 after a single dose and at steady state after multiple doses
12 months
Phase 2: Determine the PK using Cmax of INV-9956
Time Frame: 12 months
To determine the pharmacokinetics (PK) using Cmax of INV-9956 after a single dose and at steady state after multiple doses
12 months
Phase 2: Determine the blood concentration of steroid hormone
Time Frame: 12 months
To determine the blood concentration of steroid hormones at various timepoints as PD markers for INV-9956
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Ionova Life Sciences Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2025

Primary Completion (Estimated)

January 17, 2028

Study Completion (Estimated)

January 17, 2028

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INV-9956-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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