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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508386-32-00 | Other Identifier | EU CTIS Number |
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The study has ended
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A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation: VVD-130850 Single Agent | Experimental | Participants will receive ascending doses of VVD-130850, orally, once daily in 21-day treatment cycles during the dose escalation phase. |
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| Dose Escalation: VVD-130850 + Pembrolizumab Combination Therapy | Experimental | Participants will receive ascending doses of VVD-130850, orally, once daily, along with pembrolizumab intravenous (IV) infusion, every 3 weeks (Q3W) in 21-day treatment cycles during the dose escalation phase. |
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| Dose Expansion: VVD-130850 Single Agent | Experimental | Participants will receive VVD-130850 at recommended dose for expansion (RDE), orally, once daily in 21-day treatment cycles during the dose expansion phase. |
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| Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy | Experimental | Participants will receive VVD-130850 at RDE orally, once daily along with pembrolizumab IV infusion, Q3W in 21-day treatment cycles during the dose expansion phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVD-130850 | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period | Incidence and severity of DLTs will be assessed per DLT criteria set forth in the protocol based on adverse events (AEs) evaluated per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | From Day 1 to Day 21 of Cycle 1 [cycle length=21 days] |
| Dose Expansion: Number of Participants with AEs and Serious Adverse Events (SAEs) | Up to approximately 4 years | |
| Dose Expansion: Number of Participants with Clinically Significant Changes in Vital Signs | Up to approximately 4 years | |
| Dose Expansion: Number of Participants with Clinically Significant Changes in Laboratory Evaluations | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters | Number of participants with changes in QT/QTc interval and other ECG parameters will be assessed. | Up to approximately 4 years |
| Dose Escalation: Recommended Dose for Expansion (RDE) of VVD-130850 as a Single Agent and in Combination with Pembrolizumab |
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Key Inclusion Criteria:
Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Adequate organ and bone marrow function as defined in the protocol.
For Combination Therapy Expansion:
Measurable disease by RECIST version 1.1 as assessed by the Investigator.
Key Exclusion Criteria:
Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
Prior allogeneic transplantation.
History of cardiac diseases as defined in detail in the protocol.
Clinically significant infection or any eye infection.
Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
Combination Therapy Expansion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Research Institute | Los Angeles | California | 90027 | United States | ||
| Florida Cancer Specialists |
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| Pembrolizumab | Drug | IV infusion |
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The RDE will be based on safety, pharmacokinetics, pharmacodynamic biomarker data, and preliminary anti-tumor activity collected during the study as defined by the safety review committee. |
| Up to approximately 4 years |
| Dose Expansion: Overall Response Rate (ORR) | ORR is defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment. | Up to approximately 4 years |
| Dose Expansion: Duration of Response (DoR) | DOR is defined as the time from initial response of CR or PR to progressive disease or death, whichever comes first per RECIST version 1.1 by investigator assessment. | Up to approximately 4 years |
| Dose Expansion: Progression-free Survival (PFS) | PFS is defined as the time from the date of randomization to the time of confirmed disease progression or death, whichever occurs first per RECIST version 1.1 by investigator assessment. | Up to approximately 4 years |
| Dose Expansion: Disease Control Rate (DCR) | DCR is defined as the percentage of participants achieving CR or PR, or stable disease (SD) per RECIST version 1.1 by investigator assessment. | Up to approximately 4 years |
| Dose Escalation and Expansion: Area Under the Plasma Concentration-time Curve (AUC) of VVD-130850 | Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) |
| Dose Escalation and Expansion: Maximum Plasma Concentration (Cmax) of VVD-130850 | Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) |
| Dose Escalation and Expansion: Apparent Terminal Half-life (t1/2) of VVD-130850 | Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) |
| Sarasota |
| Florida |
| 34232 |
| United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| NEXT Austin | Austin | Texas | 78758 | United States |
| MDACC | Houston | Texas | 77030 | United States |
| NEXT Dallas | Irving | Texas | 75039 | United States |
| NEXT San Antonio | San Antonio | Texas | 78299 | United States |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| NEXT Virginia | Fairfax | Virginia | 22031 | United States |
| Blacktown Hospital | Blacktown | New South Wales | Australia |
| Orange Health Service | Orange | New South Wales | Australia |
| Gold Coast University Hospital | Southport | Queensland | Australia |
| Cancer Research South Australia | Adelaide | Australia |
| ICON Cancer Research | South Brisbane | Australia |
| START Barcelona Hospital HM Nou Delfos | Barcelona | Spain |
| Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| NEXT Madrid | Madrid | Spain |
| START Madrid CIOCC | Madrid | Spain |
| Start Madrid-FJD, Hospital Fundacion Jimenez Diaz | Madrid | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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