Advanced Metastatic Castration Resistant Prostate CancerPhase 1/2NCT06609005
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
A Phase 1/2 study testing INV-9956 in people with Advanced Metastatic Castration Resistant Prostate Cancer, run by Shenzhen Ionova Life Sciences Co., Ltd. at 22 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- INV-9956
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 23 Jan 2025to 17 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 2 countries
China15 sites, 15 recruiting
- Not yet recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality
Chuanliang Cui, MD, PhD, 13691489319, 1008ccl@163.com
Chuanliang Cui, MD
- Not yet recruiting
Hu'nan Cancer Hospital
Changsha, Hu'Nan, 410006
Shusuan Jiang, +86-18608408523, jiangshusuan@hnca.org.cn
Shusuan Jiang
- Not yet recruiting
The First People's Hospital of Foshan
Foshan, Guangdong
Rong Huang, +86-18038865000, nnjbhg@163.com
Rong Huang
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Ning Xu, +86-13235907575, drxun@163.com
Ning Xu
- Recruiting
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Peng Zhao, +86-13958124783, zhaop@zju.edu.cn
Peng Zhao
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Dahong Zhang, +86-13858019285, zjsgcp@126.com
Dahong Zhang
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan
Xiaoping Zhang, MD, PhD, +86-18602752025, xzhang@hust.edu.cn
Xiaoping Zhang, MD, PhD
- Recruiting
Shandong Cancer Hospital
Ji'nan, Shandong, 250000
Yuping Sun, +86-13370582181, 13370582181@163.com
Jiasheng Bian, +86-15954104097, sdbjs232466@sina.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Cheng Zhang, +86-13607080357
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Hongqian Guo, +86-13605171690, gymwpi@126.com
Hongqian Guo
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jian Zhang, +86-21-64175590, syner2000@163.com
Dingwei Ye
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801
Yu Zeng, +86-18040097265, zeng_yu03@163.com
Yu Zeng
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300202
Xin Yao, +86-13803000688, yaoxin@tjmuch.com
Xin Yao
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Wei Chen, +86 577 5557 9937, 2818777033@qq.com
Wei Chen
- Recruiting
He'nan Cancer Hospital
Zhengzhou, He'Nan, 450000
Tiejun Yang, +86-13967189416, hxj319@163.com
Xingjiang Hu, +86-136537129999, tirjunyang@163.com
United States7 sites, 7 recruiting
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
Blake Patterson, 703-783-4505, bpatterson@nextoncology.com
Mohamed Salkeni, MD
- Recruiting
Next Oncology - Houston
Houston, Texas, 77054
Paige Day, (210) 580-9480, pday@nextoncology.com
Peter DeMaria, MD
- Recruiting
Hoag Family Cancer Institute
Newport Beach, California, 92663
Patrice Jones, 9497645501, clinicaltrials.@hoag.org
David Benjamin, MD
- Recruiting
UC Irvine Medical Center
Orange, California, 92868
Hazel Dimasuay, 714-509-2170, hdimasua@hs.uci.edu
Edward Uchio, MD
- Recruiting
UT Health
San Antonio, Texas, 78229
Epp Goodwin, 210-450-5798, goodwine@uthscsa.edu
John Sarantopoulos, MD
- Recruiting
Honor Health
Scottsdale, Arizona, 85258
Andrea House, clinicaltrials@honorhealth.com
Michael Gordon, MD
- Recruiting
Summit Cancer Centers
Spokane, Washington, 99208
Monika Chaudhry, 509-251-8973, Monika.Chaudhry@aoncology.com
Arvind Chaudhry, MD, PhD
About this study
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
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.
Read the 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.
- Being tested
- INV-9956
- Keywords
- mCRPC, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-9956Drug
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 INV-9956 Dose escalation Dose level 1 | Experimental | INV-9956 Dose escalation Dose level 1 is co-administered with dexamethasone and fludrocortisone acetate Receives: Drug: INV-9956 |
| Phase 1 INV-9956 Dose escalation Dose level 2 | Experimental | INV-9956 Dose escalation Dose level 2 is co-administered with dexamethasone and fludrocortisone acetate Receives: Drug: INV-9956 |
| Phase 1 INV-9956 Dose escalation Dose level 3 | Experimental | INV-9956 Dose escalation Dose level 3 is co-administered with dexamethasone and fludrocortisone acetate Receives: Drug: INV-9956 |
| Phase 2 INV-9956 Dose expansion - Cohort A | Experimental | INV-9956 is co-administered with dexamethasone and fludrocortisone acetate Receives: Drug: INV-9956 |
| Phase 2 INV-9956 Dose expansion - Cohort B | Experimental | INV-9956 is co-administered with dexamethasone and fludrocortisone acetate Receives: Drug: INV-9956 |
| Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 4 | Experimental | INV-9956 Dose escalation Dose level 4 is co-administered with dexamethasone and fludrocortisone acetate Receives: Drug: INV-9956 |
| Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 5 | Experimental | INV-9956 Dose escalation Dose level 5 is co-administered with dexamethasone and fludrocortisone acetate Receives: Drug: INV-9956 |
| Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 6 | Experimental | INV-9956 Dose escalation Dose level 6 is co-administered with dexamethasone and fludrocortisone acetate Receives: Drug: INV-9956 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Maximum tolerated dose (MTD)
The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.
Measured: Within first 28 days of treatment
Phase 1: Recommended dose range (RDR)
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
Measured: 12 months
Phase 2: Evaluate Radiographic progression-free survival (rPFS)
To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
Measured: 12 months
Phase 2: Evaluate overall response rate (ORR)
To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
Measured: 12 months
Secondary outcomes (10)
Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0
To analyze the safety profile of INV-9956 as a single agent by AE, clinical lab test results, ECG and Vital signs changes
Measured: 12 months
Phase 1: Determine the PK using AUC of INV-9956
To determine the pharmacokinetics (PK) using AUC of INV-9956 after a single dose and at steady state after multiple doses
Measured: 12 months
Phase 1: Determine the PK using Cmax of INV-9956
To determine the pharmacokinetics (PK) using Cmax of INV-9956 after a single dose and at steady state after multiple doses
Measured: 12 months
Phase 1: Determine the blood concentration of steroid hormone
To determine the blood concentration of steroid hormones at various timepoints as PD markers for INV-9956
Measured: 12 months
Phase 1: Evaluate Radiographic progression-free survival (rPFS)
To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
Measured: 12 months
Phase 1: Evaluate overall response rate (ORR)
To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
Measured: 12 months
Phase 2: Characterize the safety of INV-9956 as assessed by CTCAE v5.0
To analyze the safety profile of INV-9956 as a single agent by AE, clinical lab test results, ECG and Vital signs changes
Measured: 12 months
Phase 2: Determine the PK using AUC of INV-9956
To determine the pharmacokinetics (PK) using AUC of INV-9956 after a single dose and at steady state after multiple doses
Measured: 12 months
Phase 2: Determine the PK using Cmax of INV-9956
To determine the pharmacokinetics (PK) using Cmax of INV-9956 after a single dose and at steady state after multiple doses
Measured: 12 months
Phase 2: Determine the blood concentration of steroid hormone
To determine the blood concentration of steroid hormones at various timepoints as PD markers for INV-9956
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start23 Jan 2025
- Primary completion17 Jan 2028 (estimated)
- Study completion17 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609005
- Sponsor's protocol ID
- INV-9956-101
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06609005
- Acronym / sponsor ID
- INV-9956-101
- Keywords
- mCRPC, Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 17 Jan 2028 (estimated)
- Study completion
- 17 Jan 2028 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Phase 1 INV-9956 Dose escalation Dose level 1 | Experimental | Drug: INV-9956INV-9956 Dose escalation Dose level 1 is co-administered with dexamethasone and fludrocortisone acetate |
| Phase 1 INV-9956 Dose escalation Dose level 2 | Experimental | Drug: INV-9956INV-9956 Dose escalation Dose level 2 is co-administered with dexamethasone and fludrocortisone acetate |
| Phase 1 INV-9956 Dose escalation Dose level 3 | Experimental | Drug: INV-9956INV-9956 Dose escalation Dose level 3 is co-administered with dexamethasone and fludrocortisone acetate |
| Phase 2 INV-9956 Dose expansion - Cohort A | Experimental | Drug: INV-9956INV-9956 is co-administered with dexamethasone and fludrocortisone acetate |
| Phase 2 INV-9956 Dose expansion - Cohort B | Experimental | Drug: INV-9956INV-9956 is co-administered with dexamethasone and fludrocortisone acetate |
| Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 4 | Experimental | Drug: INV-9956INV-9956 Dose escalation Dose level 4 is co-administered with dexamethasone and fludrocortisone acetate |
| Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 5 | Experimental | Drug: INV-9956INV-9956 Dose escalation Dose level 5 is co-administered with dexamethasone and fludrocortisone acetate |
| Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 6 | Experimental | Drug: INV-9956INV-9956 Dose escalation Dose level 6 is co-administered with dexamethasone and fludrocortisone acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INV-9956INV-9956 is co-administered with dexamethasone and fludrocortisone acetate | Drug | Phase 1 INV-9956 Dose escalation Dose level 1, Phase 1 INV-9956 Dose escalation Dose level 2, Phase 1 INV-9956 Dose escalation Dose level 3, Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 4, Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 5, Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 6, Phase 2 INV-9956 Dose expansion - Cohort A, Phase 2 INV-9956 Dose expansion - Cohort B |
Primary outcome
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.
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
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)
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)
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INV-9956 in people with Advanced Metastatic Castration Resistant Prostate Cancer, run by Shenzhen Ionova Life Sciences Co., Ltd. at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhu, MD, MBA (1 908 240 7514, yi.zhu@ionovabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Maximum tolerated dose (MTD) (time frame: Within first 28 days of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.