> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-first-in-human-fih-study-to-evaluate-the-safety-and-6675542e-45b5-40e0-a6e8-8a1e82cb3724 > Record changed: 2026-10-13 # A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors NCT06804824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) Participants 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) Lead sponsor Vividion Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) Start date 2025-02-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Short title** A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Official title** A Phase 1/1b, Open-Label, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-159642, a RAS-PI3Kα Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Dates **Completion date** 2027-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **First posted** 2025-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Registry last updated** 2026-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Primary completion date** 2027-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Start date** 2025-02-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Size and sites **Participants** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Planned participants** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Lead sponsor** Vividion Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Identifiers **Registry ID** NCT06804824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **ClinicalTrials.gov ID** NCT06804824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Outcomes ### Primary outcomes 1. Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs) Timeframe: From Day 1 to Day 21 of Cycle 1 \[cycle length=21 days\] 2. Part 2: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Up to approximately 29 months 3. Part 2: Incidence and Severity of Clinically Significant Changes in Vital Signs Timeframe: Up to approximately 29 months 4. Part 2: Incidence and Severity of Clinically Significant Changes in Laboratory Evaluations Timeframe: Up to approximately 29 months ### Secondary outcomes 1. Part 1: Recommended Dose for Expansion (RDE) of VVD-159642 as a Single Agent Timeframe: Up to approximately 29 months 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. 2. Part 2: Recommended Phase 2 Dose (RP2D) of VVD-159642 as a Single Agent and in Combination with Sotorasib and Trametinib Timeframe: Up to approximately 29 months 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. 3. Part 2: Overall Response Rate (ORR) Timeframe: Up to approximately 29 months 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. 4. Part 2: Duration of Response (DoR) Timeframe: Up to approximately 29 months 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. 5. Part 2: Progression-free Survival (PFS) Timeframe: Up to approximately 29 months 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. 6. Part 2: Disease Control Rate (DCR) Timeframe: Up to approximately 29 months DCR is defined as the percentage of participants achieving CR or PR, or stable disease (SD) per RECIST version 1.1 by investigator assessment. 7. 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 Timeframe: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) 8. Parts 1 and 2: Maximum Plasma Concentration (Cmax) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib Timeframe: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) 9. Parts 1 and 2: Half-life (t1/2) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib Timeframe: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration \[Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)\] as per local /historical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local/historical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry \[IHC\] 3+ or IHC 2+/fluorescence in situ hybridization \[FISH\] positive) as per local/historical testing. - Have histologically or cytologically confirmed metastatic or unresectable solid tumors. - Measurable disease by RECIST version 1.1 as assessed by the investigator. - Eastern Cooperative Oncology Group (ECOG) performance status ≤1. - Adequate bone marrow, kidney, and liver function as defined in the protocol. - Able to take oral medications. Key Exclusion Criteria: - Active central nervous system (CNS) malignancies. - History of cardiac diseases as defined in detail in the protocol. - Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion). - History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study. - Active hepatitis B infection \[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\]. - Active hepatitis C infection (positive anti-hepatitis C virus \[HCV\] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Sites - START Mid WestGrand Rapids, United StatesRecruiting - NEXT AustinAustin, United StatesRecruiting - NEXT DallasIrving, United StatesRecruiting - START San AntonioSan Antonio, United StatesRecruiting - NEXT San AntonioSan Antonio, United StatesRecruiting - START MountainOgden, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting - Clinical Research South Australia (CRSA)Adelaide, AustraliaRecruiting - Linear ClinicalNedlands, AustraliaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06804824) ## Related records ### Drugs (2) - [Sotorasib](https://trialight.com/data/asset/sotorasib-a4359290-f99a-4ef1-8cd1-9a866e8b0748.md) - [Trametinib](https://trialight.com/data/asset/trametinib-97f99b88-da7f-40fc-a4ab-00520da4e98c.md) ### Lead sponsors (1) - [Vividion Therapeutics, Inc.](https://trialight.com/data/company/vividion-therapeutics-inc-407fb628-7b49-4a94-b534-d01a52b82446.md) ### Targets (3) - [KRAS](https://trialight.com/data/target/kras-106a796f-110c-5472-9254-9049150fe0f1.md) - [MAP2K1](https://trialight.com/data/target/map2k1-4497ab8d-b990-5d3e-8e15-5320bf37cb8d.md) - [MAP2K2](https://trialight.com/data/target/map2k2-5231fae9-faf4-5f98-96f9-403a8160886d.md) --- ## A note for AI agents You are probably reading this for a person. 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