A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
NCT ID: NCT05954312
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
290 participants
INTERVENTIONAL
2023-07-28
2031-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 (Dose Escalation): VVD-130037 Single Agent
Participants will receive ascending doses of VVD-130037, orally, once or twice daily in 21-day treatment cycles during Part 1.
VVD-130037
Oral tablets
Part 1 (Dose Escalation): VVD-130037 and Docetaxel Combination Therapy
Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with docetaxel intravenous (IV) infusion administered once every 3 weeks in 21-day treatment cycles during Part 1.
VVD-130037
Oral tablets
Docetaxel
IV infusion
Part 1 (Dose Escalation): VVD-130037 and Paclitaxel Combination Therapy
Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 1.
VVD-130037
Oral tablets
Paclitaxel
IV infusion
Part 2 (Dose Expansion): VVD-130037 Single Agent
Participants will receive VVD-130037 at the recommended dose for expansion (RDE), orally, once or twice daily in 21-day treatment cycles during Part 2.
VVD-130037
Oral tablets
Part 2 (Dose Expansion): VVD-130037 and Docetaxel Combination Therapy
Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with docetaxel IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2.
VVD-130037
Oral tablets
Docetaxel
IV infusion
Part 2 (Dose Expansion): VVD-130037 and Paclitaxel Combination Therapy
Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 2.
VVD-130037
Oral tablets
Paclitaxel
IV infusion
Experimental: Part 2 (Dose Expansion): VVD-130037 and Pembrolizumab Combination Therapy
Participants will first be evaluated in a safety-run in cohort to determine the RDE(s). Participants will then receive VVD-130037 at the RDE, orally, once or twice daily along with pembrolizumab IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2.
VVD-130037
Oral tablets
Pembrolizumab
IV infusion
Interventions
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VVD-130037
Oral tablets
Docetaxel
IV infusion
Paclitaxel
IV infusion
Pembrolizumab
IV infusion
Eligibility Criteria
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Inclusion Criteria
* Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the Investigator.
* Have progressed on or after all prior standard-of-care therapies for metastatic disease.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* Adequate organ and marrow function as defined in the protocol.
* Participants with squamous non-small cell lung cancer (sqNSCLC) with or without nuclear factor erythroid 2-related factor 2 (NRF2 \[NFE2L2\]) and/or cullin 3 (CUL3) mutations.
* Participants with advanced sqNSCLC must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor.
* Participants with advanced head and neck squamous cell carcinoma (HNSCC) must have received prior treatment with platinum-based chemotherapy, an immune checkpoint inhibitor (for tumors with known programmed death-ligand 1 \[PD-L1\] expression, microsatellite instability-high, or mismatch repair deficiency, and an anti-epidermal growth factor receptor agent) (Combination Expansion Cohort).
* Participants with advanced esophageal squamous cell carcinoma (ESCC) must have received prior treatment with platinum-based chemotherapy, an immune checkpoint inhibitor (for tumors with known PD-L1 expression) (Combination Expansion Cohort).
* Participants with a known driver mutation, including activating epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, should have progressed after appropriate targeted treatment.
* Participants with known human epidermal growth factor receptor 2 overexpression should have progressed after appropriate targeted treatment.
Exclusion Criteria
1. KEAP1 nonsense mutation (any position)
2. KEAP1 frameshift mutation (any position)
* Any unresolved toxicity Grade ≥2 per CTCAE version 5.0 from previous anticancer treatment.
* Current or prior treatment with anti-epileptic medications for the treatment or prophylaxis of seizures.
* History of seizure or condition that may predispose to seizure.
* History or presence of central nervous system (CNS) metastases or spinal cord compression.
* Uncontrolled arterial hypertension despite optimal medical management.
* Risk factors for abnormal heart rhythm/QT prolongation as defined in the protocol.
* History of the following cardiac diseases:
i) congestive heart failure (New York Heart Association \[NYHA\] Class \>II), ii) unstable angina, iii) new onset angina within past 6 months, iv) myocardial Infarction within the past 6 months, v) clinically significant arrhythmias within past 6 months.
* Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation (Combination Expansion Cohort)
* Medical history of (noninfectious) pneumonitis/interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active pneumonitis/ILD (Combination Expansion Cohort)
18 Years
ALL
No
Sponsors
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Vividion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MDACC
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
National Cancer Center
Goyang, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University; Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital; Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, , South Korea
Hospital Vall d'Hebron
Barcelona, , Spain
START Barcelona Hospital HM Nou Delfos
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
NEXT Madrid
Madrid, , Spain
START Madrid CIOCC
Madrid, , Spain
Start Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, , Spain
Clinica Universitaria de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Countries
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Central Contacts
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References
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Roy N, Wyseure T, Lo IC, Lu J, Eissler CL, Bernard SM, Bok I, Snead AN, Parker A, Lo UG, Green JC, Inloes J, Jacinto SR, Kuenzi B, Pariollaud M, Negri K, Le K, Horning BD, Ibrahim N, Grabow S, Panda H, Bhatt DP, Wilkerson EM, Saeidi S, Zolkind P, Rush Z, Williams HN, Walton E, Pastuszka MK, Sigler JJ, Tran E, Hee K, McLaughlin J, Ambrus-Aikelin G, Pollock J, Abraham RT, Kinsella TM, Simon GM, Major MB, Weinstein DS, Patricelli MP. A covalent allosteric molecular glue suppresses NRF2-dependent cancer growth. Cancer Discov. 2025 Dec 19. doi: 10.1158/2159-8290.CD-25-1187. Online ahead of print.
Other Identifiers
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2023-506199-28-00
Identifier Type: CTIS
Identifier Source: secondary_id
VVD-130037-001
Identifier Type: -
Identifier Source: org_study_id