Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-08 @ 9:33 PM
Study NCT ID:
NCT06609005
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Maximum tolerated dose (MTD)', 'timeFrame': 'Within first 28 days of treatment', 'description': 'The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.'}, {'measure': 'Phase 1: Recommended dose range (RDR)', 'timeFrame': '12 months', 'description': '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'}, {'measure': 'Phase 2: Evaluate Radiographic progression-free survival (rPFS)', 'timeFrame': '12 months', 'description': 'To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)'}, {'measure': 'Phase 2: Evaluate overall response rate (ORR)', 'timeFrame': '12 months', 'description': 'To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)'}], 'secondaryOutcomes': [{'measure': 'Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0', 'timeFrame': '12 months', 'description': 'To analyze the safety profile of INV-9956 as a single agent by AE, clinical lab test results, ECG and Vital signs changes'}, {'measure': 'Phase 1: Determine the PK using AUC of INV-9956', 'timeFrame': '12 months', 'description': 'To determine the pharmacokinetics (PK) using AUC of INV-9956 after a single dose and at steady state after multiple doses'}, {'measure': 'Phase 1: Determine the PK using Cmax of INV-9956', 'timeFrame': '12 months', 'description': 'To determine the pharmacokinetics (PK) using Cmax of INV-9956 after a single dose and at steady state after multiple doses'}, {'measure': 'Phase 1: Determine the blood concentration of steroid hormone', 'timeFrame': '12 months', 'description': 'To determine the blood concentration of steroid hormones at various timepoints as PD markers for INV-9956'}, {'measure': 'Phase 1: Evaluate Radiographic progression-free survival (rPFS)', 'timeFrame': '12 months', 'description': 'To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)'}, {'measure': 'Phase 1: Evaluate overall response rate (ORR)', 'timeFrame': '12 months', 'description': 'To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)'}, {'measure': 'Phase 2: Characterize the safety of INV-9956 as assessed by CTCAE v5.0', 'timeFrame': '12 months', 'description': 'To analyze the safety profile of INV-9956 as a single agent by AE, clinical lab test results, ECG and Vital signs changes'}, {'measure': 'Phase 2: Determine the PK using AUC of INV-9956', 'timeFrame': '12 months', 'description': 'To determine the pharmacokinetics (PK) using AUC of INV-9956 after a single dose and at steady state after multiple doses'}, {'measure': 'Phase 2: Determine the PK using Cmax of INV-9956', 'timeFrame': '12 months', 'description': 'To determine the pharmacokinetics (PK) using Cmax of INV-9956 after a single dose and at steady state after multiple doses'}, {'measure': 'Phase 2: Determine the blood concentration of steroid hormone', 'timeFrame': '12 months', 'description': 'To determine the blood concentration of steroid hormones at various timepoints as PD markers for INV-9956'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mCRPC', 'Prostate Cancer'], 'conditions': ['Advanced Metastatic Castration Resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion.\n\nPhase 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.\n\nPhase 2 aims to reassure the safety profile and better define efficacy. Phase 2 consists of up to 2 cohorts by different AR gene status:\n\n* Cohort A: AR mutant CRPC\n* Cohort B: AR wide-type CRPC (optional) Currently enrolling patients under Phase 2.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written informed consent obtained.\n2. Male aged ≥ 18 years.\n3. Histologically confirmed adenocarcinoma of the prostate.\n4. Castration resistant prostate cancer with serum testosterone \\<50 ng/dL.\n5. Metastatic disease.\n6. Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.\n7. 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.\n8. ECOG performance status 0-1.\n9. Adequate marrow, liver and kidney function.\n10. INR ≤1.5.\n11. Able to swallow study treatment.\n12. Has a life expectancy of \\> 3 months.\n\nExclusion Criteria:\n\n1. 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.\n2. History of pituitary or adrenal dysfunction.\n3. Poorly controlled diabetes mellitus.\n4. Clinically significant abnormality in serum potassium and sodium.\n5. 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.\n6. Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.\n7. History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.\n8. Prolonged QTcF interval.\n9. Active infection or other medical condition that would make corticosteroid contraindicated."}, 'identificationModule': {'nctId': 'NCT06609005', 'briefTitle': 'A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Ionova Life Sciences Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'INV-9956-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 INV-9956 Dose escalation Dose level 1', 'description': 'INV-9956 Dose escalation Dose level 1 is co-administered with dexamethasone and fludrocortisone acetate', 'interventionNames': ['Drug: INV-9956']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 INV-9956 Dose escalation Dose level 2', 'description': 'INV-9956 Dose escalation Dose level 2 is co-administered with dexamethasone and fludrocortisone acetate', 'interventionNames': ['Drug: INV-9956']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 INV-9956 Dose escalation Dose level 3', 'description': 'INV-9956 Dose escalation Dose level 3 is co-administered with dexamethasone and fludrocortisone acetate', 'interventionNames': ['Drug: INV-9956']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 INV-9956 Dose expansion - Cohort A', 'description': 'INV-9956 is co-administered with dexamethasone and fludrocortisone acetate', 'interventionNames': ['Drug: INV-9956']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 INV-9956 Dose expansion - Cohort B', 'description': 'INV-9956 is co-administered with dexamethasone and fludrocortisone acetate', 'interventionNames': ['Drug: INV-9956']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 4', 'description': 'INV-9956 Dose escalation Dose level 4 is co-administered with dexamethasone and fludrocortisone acetate', 'interventionNames': ['Drug: INV-9956']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 5', 'description': 'INV-9956 Dose escalation Dose level 5 is co-administered with dexamethasone and fludrocortisone acetate', 'interventionNames': ['Drug: INV-9956']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 6', 'description': 'INV-9956 Dose escalation Dose level 6 is co-administered with dexamethasone and fludrocortisone acetate', 'interventionNames': ['Drug: INV-9956']}], 'interventions': [{'name': 'INV-9956', 'type': 'DRUG', 'description': 'INV-9956 is co-administered with dexamethasone and fludrocortisone acetate', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrea House', 'role': 'CONTACT', 'email': 'clinicaltrials@honorhealth.com', 'phoneExt': '480-323-1791'}, {'name': 'Michael Gordon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Honor Health', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patrice Jones', 'role': 'CONTACT', 'email': 'clinicaltrials.@hoag.org', 'phone': '9497645501'}, {'name': 'David Benjamin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hoag Family Cancer Institute', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hazel Dimasuay', 'role': 'CONTACT', 'email': 'hdimasua@hs.uci.edu', 'phone': '714-509-2170'}, {'name': 'Edward Uchio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paige Day', 'role': 'CONTACT', 'email': 'pday@nextoncology.com', 'phone': '(210) 580-9480'}, {'name': 'Peter DeMaria, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Next Oncology - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Epp Goodwin', 'role': 'CONTACT', 'email': 'goodwine@uthscsa.edu', 'phone': '210-450-5798'}, {'name': 'John Sarantopoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Health', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Blake Patterson', 'role': 'CONTACT', 'email': 'bpatterson@nextoncology.com', 'phone': '703-783-4505'}, {'name': 'Mohamed Salkeni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '99208', 'city': 'Spokane', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monika Chaudhry', 'role': 'CONTACT', 'email': 'Monika.Chaudhry@aoncology.com', 'phone': '509-251-8973'}, {'name': 'Arvind Chaudhry, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Summit Cancer Centers', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ning Xu', 'role': 'CONTACT', 'email': 'drxun@163.com', 'phone': '+86-13235907575'}, {'name': 'Ning Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': "He'Nan", 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tiejun Yang', 'role': 'CONTACT', 'email': 'hxj319@163.com', 'phone': '+86-13967189416'}, {'name': 'Xingjiang Hu', 'role': 'CONTACT', 'email': 'tirjunyang@163.com', 'phone': '+86-136537129999'}, {'name': 'Tiejun Yang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xingjiang Hu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "He'nan Cancer Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '410006', 'city': 'Changsha', 'state': "Hu'Nan", 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shusuan Jiang', 'role': 'CONTACT', 'email': 'jiangshusuan@hnca.org.cn', 'phone': '+86-18608408523'}, {'name': 'Shusuan Jiang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hu'nan Cancer Hospital", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongqian Guo', 'role': 'CONTACT', 'email': 'gymwpi@126.com', 'phone': '+86-13605171690'}, {'name': 'Hongqian Guo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '110801', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Zeng', 'role': 'CONTACT', 'email': 'zeng_yu03@163.com', 'phone': '+86-18040097265'}, {'name': 'Yu Zeng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Liaoning Cancer Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250000', 'city': "Ji'nan", 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuping Sun', 'role': 'CONTACT', 'email': '13370582181@163.com', 'phone': '+86-13370582181'}, {'name': 'Jiasheng Bian', 'role': 'CONTACT', 'email': 'sdbjs232466@sina.com', 'phone': '+86-15954104097'}, {'name': 'Yuping Sun', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jiasheng Bian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong Cancer Hospital'}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Zhang', 'role': 'CONTACT', 'email': 'syner2000@163.com', 'phone': '+86-21-64175590'}, {'name': 'Dingwei Ye', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jian Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300202', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Yao', 'role': 'CONTACT', 'email': 'yaoxin@tjmuch.com', 'phone': '+86-13803000688'}, {'name': 'Xin Yao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Zhao', 'role': 'CONTACT', 'email': 'zhaop@zju.edu.cn', 'phone': '+86-13958124783'}, {'name': 'Peng Zhao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dahong Zhang', 'role': 'CONTACT', 'email': 'zjsgcp@126.com', 'phone': '+86-13858019285'}, {'name': 'Dahong Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yi Zhu, MD, MBA', 'role': 'CONTACT', 'email': 'yi.zhu@ionovabio.com', 'phone': '1 908 240 7514'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Ionova Life Sciences Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}