Back to Trials
NCT05954312PHASE1Recruiting

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

Vividion Therapeutics, Inc.

Start Date

7/28/2023

Completion Date

2/28/2031

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 Criteria

Age Range: 18 years to No maximum

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)

Interventions

DRUG

VVD-130037

DRUG

Docetaxel

DRUG

Paclitaxel

DRUG

Pembrolizumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Advanced Solid Tumors

Locations

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

MDACC

Houston, Texas 77030

United States

NEXT Dallas

Irving, Texas 75039

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

National Cancer Center

Goyang,

South Korea

The Catholic University of Korea, St. Vincent's Hospital

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