> 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-b145ebef-8578-4d37-8777-0a40a65f8ae6 > Record changed: 2026-11-04 # A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors NCT06188208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) Participants 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) Lead sponsor Vividion Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) Start date 2024-01-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) Number of sites 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Short title** A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Official title** A Phase 1, Open-Label, 2-Part, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of the STAT3 Inhibitor VVD-130850 as Single Agent and in Combination With Checkpoint Inhibition in Participants With Advanced Solid and Hematologic Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Reason stopped** The study has ended Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Dates **Completion date** 2026-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **First posted** 2024-01-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Registry last updated** 2026-06-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Primary completion date** 2026-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Start date** 2024-01-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Size and sites **Actual participants** 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Participants** 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Number of sites** 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Lead sponsor** Vividion Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Identifiers **Registry ID** NCT06188208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **ClinicalTrials.gov ID** NCT06188208 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Outcomes ### Primary outcomes 1. Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period Timeframe: From Day 1 to Day 21 of Cycle 1 \[cycle length=21 days\] 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. 2. Dose Expansion: Number of Participants with AEs and Serious Adverse Events (SAEs) Timeframe: Up to approximately 4 years 3. Dose Expansion: Number of Participants with Clinically Significant Changes in Vital Signs Timeframe: Up to approximately 4 years 4. Dose Expansion: Number of Participants with Clinically Significant Changes in Laboratory Evaluations Timeframe: Up to approximately 4 years ### Secondary outcomes 1. Dose Escalation: QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters Timeframe: Up to approximately 4 years Number of participants with changes in QT/QTc interval and other ECG parameters will be assessed. 2. Dose Escalation: Recommended Dose for Expansion (RDE) of VVD-130850 as a Single Agent and in Combination with Pembrolizumab Timeframe: Up to approximately 4 years 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. 3. Dose Expansion: Overall Response Rate (ORR) Timeframe: Up to approximately 4 years 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. Dose Expansion: Duration of Response (DoR) Timeframe: Up to approximately 4 years 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. Dose Expansion: Progression-free Survival (PFS) Timeframe: Up to approximately 4 years 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. Dose Expansion: Disease Control Rate (DCR) Timeframe: Up to approximately 4 years 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. Dose Escalation and Expansion: Area Under the Plasma Concentration-time Curve (AUC) of VVD-130850 Timeframe: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) 8. Dose Escalation and Expansion: Maximum Plasma Concentration (Cmax) of VVD-130850 Timeframe: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days) 9. Dose Escalation and Expansion: Apparent Terminal Half-life (t1/2) of VVD-130850 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/NCT06188208) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL). 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 3. Adequate organ and bone marrow function as defined in the protocol. 4. For Combination Therapy Expansion: - Serine/threonine kinase 11/ liver kinase B1 (STK11/LKB1) mutated non-small cell lung cancer (NSCLC) as assessed by historical (local) test. - Must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor (CPI). These therapies could have been given in the same line of therapy or different lines of therapy. 5. Measurable disease by RECIST version 1.1 as assessed by the Investigator. Key Exclusion Criteria: 1. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy. 2. Prior allogeneic transplantation. 3. History of cardiac diseases as defined in detail in the protocol. 4. Clinically significant infection or any eye infection. 5. Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary). 6. Combination Therapy Expansion: - Known hypersensitivity or contraindication to pembrolizumab or any of its components. - Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation with the exception of the history of immunotherapy-related endocrinopathy controlled with ongoing medical management (e.g., hypothyroidism, adrenal insufficiency, diabetes). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Sites - California Research InstituteLos Angeles, United States - Florida Cancer SpecialistsSarasota, United States - Sarah Cannon Research InstituteNashville, United States - NEXT AustinAustin, United States - MDACCHouston, United States - NEXT DallasIrving, United States - NEXT San AntonioSan Antonio, United States - University of Utah Huntsman Cancer InstituteSalt Lake City, United States - NEXT VirginiaFairfax, United States - Blacktown HospitalBlacktown, Australia - Orange Health ServiceOrange, Australia - Gold Coast University HospitalSouthport, Australia - Cancer Research South AustraliaAdelaide, Australia - ICON Cancer ResearchSouth Brisbane, Australia - START Barcelona Hospital HM Nou DelfosBarcelona, Spain - Vall d'HebronBarcelona, Spain - Hospital Universitario 12 de OctubreMadrid, Spain - NEXT MadridMadrid, Spain - START Madrid CIOCCMadrid, Spain - Start Madrid-FJD, Hospital Fundacion Jimenez DiazMadrid, Spain Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## References ### Other registry identifiers (2) - 2023 - 2023-508386-32-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06188208) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Vividion Therapeutics, Inc.](https://trialight.com/data/company/vividion-therapeutics-inc-407fb628-7b49-4a94-b534-d01a52b82446.md) ### Conditions (1) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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