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Tests treatment safety and results for Advanced Solid Tumors
Official title A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05954312
What this study is testing
What is VVD-130037?
VVD-130037 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key 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.
You likely can't join if
- 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:
- KEAP1 nonsense mutation (any position)
- 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.
See the full eligibility criteria
- Key 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 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...
- 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)...
- 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
- 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:
- KEAP1 nonsense mutation (any position)
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Rochester, Minnesota, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Irving, Texas, United States
- Fairfax, Virginia, United States
- Goyang, South Korea
- Incheon, South Korea
- Seongnam, South Korea
- Seoul, South Korea
- Suwon, South Korea
- Barcelona, Spain
- Madrid, Spain
- Pamplona, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Sarasota, Florida, United States; Tampa, Florida, United States; Rochester, Minnesota, United States; Nashville, Tennessee, United States; Houston, Texas, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.