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A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation: VVD-159642 Single Agent | Experimental | Participants will receive ascending doses of VVD-159642, orally, daily in 21-day treatment cycles during Part 1. |
|
| Part 2: Dose Expansion (Cohort A): VVD-159642 Single Agent | Experimental | Participants will receive VVD-159642 at the recommended dose for expansion (RDE), orally, daily in 21-day treatment cycles during Part 2. |
|
| Part 2: Dose Expansion (Cohort B): VVD-159642 + Sotorasib | Experimental | Participants will receive VVD-159642 at RDE orally, daily in combination with sotorasib, in 21-day treatment cycles after a safety run-in. |
|
| Part 2: Dose Expansion (Cohort C): VVD-159642 + Trametinib | Experimental | Participants will receive VVD-159642 at RDE orally, daily in combination with trametinib, in 21-day treatment cycles after a safety run-in. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVD-159642 | Drug | Oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs) | From Day 1 to Day 21 of Cycle 1 [cycle length=21 days] | |
| Part 2: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 29 months | |
| Part 2: Incidence and Severity of Clinically Significant Changes in Vital Signs | Up to approximately 29 months | |
| Part 2: Incidence and Severity of Clinically Significant Changes in Laboratory Evaluations | Up to approximately 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Recommended Dose for Expansion (RDE) of VVD-159642 as a Single Agent | The RDE will be based on safety, tolerability, PK, and preliminary anti-tumor activity of VVD-159642 as a single agent during the dose escalation phase. | Up to approximately 29 months |
| Part 2: Recommended Phase 2 Dose (RP2D) of VVD-159642 as a Single Agent and in Combination with Sotorasib and Trametinib |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vividion Clinical Trial Call Center | Contact | 858-345-9752 | clinicaltrials@vividion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Mid West | Recruiting | Grand Rapids | Michigan | 49546 | United States | |
| NEXT Austin |
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| Sotorasib | Drug | Oral tablets |
|
| Trametinib | Drug | Oral tablets |
|
The RP2D will be based on safety, tolerability, PK and preliminary anti-tumor activity of VVD-159642 as single agent, and in combination with sotorasib and trametinib during Part 2. |
| Up to approximately 29 months |
| Part 2: 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 29 months |
| Part 2: 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 29 months |
| Part 2: 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 29 months |
| Part 2: 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 29 months |
| Parts 1 and 2: Area Under the Plasma Concentration-time Curve (AUC) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib | Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) |
| Parts 1 and 2: Maximum Plasma Concentration (Cmax) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib | Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) |
| Parts 1 and 2: Half-life (t1/2) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib | Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) |
| Recruiting |
| Austin |
| Texas |
| 78758 |
| United States |
| NEXT Dallas | Recruiting | Irving | Texas | 75039 | United States |
| START San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
| NEXT San Antonio | Recruiting | San Antonio | Texas | 78299 | United States |
| START Mountain | Recruiting | Ogden | Utah | 84401 | United States |
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| Clinical Research South Australia (CRSA) | Recruiting | Adelaide | South Australia | 5000 | Australia |
| Linear Clinical | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| ID | Term |
|---|---|
| C000706028 | sotorasib |
| C560077 | trametinib |
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