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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004808-30 | EudraCT Number |
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Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).
Part 2 VIP152 Monotherapy (Global). Part 3 dose escalation with VIP152 in combination with pembrolizumab (US only). Part 4 dose expansion with VIP152 in combination with pembrolizumab (US only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed) | Experimental | Investigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL |
|
| Dose expansion of VIP152 (BAY 1251152) / PART 2 | Experimental | Investigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL |
|
| Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3 | Experimental | Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose escalation cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI. |
|
| Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4 | Experimental | Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose expansion cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIP152 (BAY 1251152) | Drug | The starting dose of Cohort 1 will be 5 mg IV (30 minute infusion) fixed dose once weekly (5 mg/week) for 21 day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152) | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days | |
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP152 (BAY1251152) | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days | |
| Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152) | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days | |
| AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152) | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days | |
| Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of VIP152 (BAY1251152) | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days | |
| AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of VIP152 (BAY1251152) | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days | |
| Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days | |
| Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152) in combination with Keytruda® (pembrolizumab) | Cycle 1 Day 1 through Cycle 3 Day 1, where each cycle is up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response evaluation based on the response criteria as applicable (RECIST v1.1 criteria for solid tumors and revised Lugano Classification for aggressive NHL) | Up to 3 Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months) |
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Part 2 (Global), Part 3 (US Only), and Part 4 (US Only)
Inclusion Criteria:
In the addition to the above Part 3 (US Only) and Part 4 (US Only)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincerx Study Director | Vincerx Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States | ||
| Norton Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35046056 | Derived | Diamond JR, Boni V, Lim E, Nowakowski G, Cordoba R, Morillo D, Valencia R, Genvresse I, Merz C, Boix O, Frigault MM, Greer JM, Hamdy AM, Huang X, Izumi R, Wong H, Moreno V. First-in-Human Dose-Escalation Study of Cyclin-Dependent Kinase 9 Inhibitor VIP152 in Patients with Advanced Malignancies Shows Early Signs of Clinical Efficacy. Clin Cancer Res. 2022 Apr 1;28(7):1285-1293. doi: 10.1158/1078-0432.CCR-21-3617. |
| Label | URL |
|---|---|
| Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. | View source |
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| VIP152 (BAY 1251152) 30 mg | Drug | 30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle. |
|
| Keytruda | Drug | 200 mg IV fixed dose once every 3 weeks of a 21 day cycle |
|
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| VIP152 (BAY 1251152) 15 mg | Drug | The starting dose of Cohort 3 will be 15 mg IV (30 minute infusion) fixed dose once weekly (15 mg/week) for 21 day cycles. |
|
| Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days |
| Number of participants with adverse events as a measure safety and tolarability | Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months) |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Maryland Oncology Hematology | Silver Spring | Maryland | 20904 | United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| Willamette Valley Cancer Institute | Eugene | Oregon | 97401 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Avera Health | Sioux Falls | South Dakota | 57105 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| NEXT Oncology | Austin | Texas | 78758 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| Centro de Investigaciones Clínicas Viña del Mar | Viña del Mar | Valparaiso | 2540364 | Chile |
| Oncocentro | Viña del Mar | 2520598 | Chile |
| START Madrid- Fundación Jiménez Diaz | Madrid | 28040 | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D004938 | Esophageal Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D013274 | Stomach Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D015266 | Carcinoma, Merkel Cell |
| D002292 | Carcinoma, Renal Cell |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D013272 | Stomach Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000230 | Adenocarcinoma |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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