Actively Recruiting
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
Led by Vividion Therapeutics, Inc. · Updated on 2026-05-08
290
Participants Needed
26
Research Sites
396 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic or unresectable solid tumor.
- Measurable disease by RECIST v1.1 criteria as assessed by the Investigator.
- Disease progression after all prior standard-of-care therapies for metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and marrow function as defined in the protocol.
- For Part 2, participants with squamous non-small cell lung cancer (sqNSCLC) with or without NRF2 (NFE2L2) and/or CUL3 mutations.
- For Part 2, participants with advanced sqNSCLC refractory to or progressed after platinum-based doublet therapy and immune checkpoint inhibitor.
- For Part 2, participants with advanced head and neck squamous cell carcinoma (HNSCC) must have prior treatment with platinum chemotherapy, immune checkpoint inhibitor, and for some tumors, an anti-EGFR agent.
- For Part 2, participants with advanced esophageal squamous cell carcinoma (ESCC) must have prior platinum chemotherapy and immune checkpoint inhibitor.
- Participants with known driver mutations (e.g., activating EGFR mutations or ALK rearrangements) must have progressed after targeted treatments.
- Participants with human epidermal growth factor receptor 2 overexpression must have progressed after targeted treatments.
You will not qualify if you...
- Known mutation with no expected benefit from VVD-130037, including KEAP1 nonsense or frameshift mutations.
- Any unresolved toxicity Grade 2 or higher from prior anticancer treatment.
- Current or prior use of anti-epileptic medications for seizure treatment or prevention.
- History of seizures or conditions that predispose to seizures.
- History or presence of central nervous system metastases or spinal cord compression.
- Uncontrolled high blood pressure despite optimal management.
- Risk factors for abnormal heart rhythm or QT prolongation as defined in the protocol.
- History of congestive heart failure (NYHA Class >II), unstable angina, recent angina or myocardial infarction, or significant arrhythmias within the past 6 months.
- Prior Grade 3 or 4 toxicity related to immunotherapy causing treatment discontinuation (for Combination Expansion Cohort).
- Medical history of pneumonitis, interstitial lung disease (ILD), radiation pneumonitis requiring steroids, or active pneumonitis/ILD (for Combination Expansion Cohort).
AI-Screening
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Trial Site Locations
Total: 26 locations
1
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
MDACC
Houston, Texas, United States, 77030
Actively Recruiting
7
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
8
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
National Cancer Center
Goyang, South Korea
Actively Recruiting
10
The Catholic University of Korea, St. Vincent's Hospital
Goyang, South Korea
Actively Recruiting
11
Gachon University Gil Medical Center
Incheon, South Korea
Actively Recruiting
12
Seoul National University; Bundang Hospital
Seongnam, South Korea
Actively Recruiting
13
Asan Medical Center
Seoul, South Korea
Actively Recruiting
14
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
15
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
16
Severance Hospital; Yonsei University Health System
Seoul, South Korea
Actively Recruiting
17
The Catholic University of Korea, St. Vincent's Hospital
Suwon, South Korea
Actively Recruiting
18
Hospital Vall d'Hebron
Barcelona, Spain
Actively Recruiting
19
START Barcelona Hospital HM Nou Delfos
Barcelona, Spain
Actively Recruiting
20
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
21
Hospital Universitario Ramon y Cajal
Madrid, Spain
Actively Recruiting
22
NEXT Madrid
Madrid, Spain
Actively Recruiting
23
START Madrid CIOCC
Madrid, Spain
Actively Recruiting
24
Start Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain
Actively Recruiting
25
Clinica Universitaria de Navarra
Pamplona, Spain
Actively Recruiting
26
Hospital Clinico Universitario de Valencia
Valencia, Spain
Actively Recruiting
Research Team
V
Vividion Clinical Trial Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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