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Clinical Trials in the USA / NCT05954312
Recruiting Phase 1

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors

NCT05954312 · tracked via the Priya Life Science USA tracker
Sponsor
Vividion Therapeutics, Inc.
Phase
Phase 1
Started
2023-07-28
Last updated
2026-05-08

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

VVD-130037Docetaxel →Paclitaxel →Pembrolizumab →

VVD-130037: Oral tablets

Docetaxel: IV infusion

Paclitaxel: IV infusion

Pembrolizumab: IV infusion

Study summary

A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria for Parts 1 and 2: * Histologically or cytologically confirmed metastatic or unresectable solid tumor. * 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. Additional Key Inclusion Criteria for Part 2: * 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. Key Exclusion Criteria for Parts 1 and 2: * Participant is known to have a mutation that has no expectation of benefit from VVD-130037. Current such mutations include the following: 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)

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Mayo Clinic Jacksonville Jacksonville Florida Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
MDACC Houston Texas Recruiting
NEXT Dallas Irving Texas Recruiting
NEXT Virginia Fairfax Virginia Recruiting
National Cancer Center Goyang South Korea Recruiting
The Catholic University of Korea, St. Vincent's Hospital Goyang South Korea Recruiting
Gachon University Gil Medical Center Incheon South Korea Recruiting
Seoul National University; Bundang Hospital Seongnam South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital; Yonsei University Health System Seoul South Korea Recruiting
The Catholic University of Korea, St. Vincent's Hospital Suwon South Korea Recruiting
Hospital Vall d'Hebron Barcelona Spain Recruiting
START Barcelona Hospital HM Nou Delfos Barcelona Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
NEXT Madrid Madrid Spain Recruiting
START Madrid CIOCC Madrid Spain Recruiting
Start Madrid-FJD, Hospital Fundacion Jimenez Diaz Madrid Spain Recruiting
Clinica Universitaria de Navarra Pamplona Spain Recruiting
Hospital Clinico Universitario de Valencia Valencia Spain Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05954312 on ClinicalTrials.gov ↗ ← All trials in the USA