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Study of VVD-130037 for Advanced Solid Tumors

This study is testing a new drug called VVD-130037 in people with advanced solid tumors that have continued to grow despite standard treatments. It's a "first-in-human" study, meaning it's one of the first times this drug is being given to people. Researchers want to see how safe VVD-130037 is, how well you tolerate it, and what side effects it might cause. VVD-130037 will be given alone or in combination with other common cancer drugs like docetaxel, paclitaxel, or pembrolizumab. The main goal is to find a safe dose and understand its effects. You would need to have a confirmed solid tumor that has spread or cannot be removed by surgery, and your tumor must be measurable.

Study design
This is a first-in-human study with an unclear status, planning to enroll 290 participants. It will test VVD-130037 alone and in combination with other drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in Part 2 of the study will be followed for safety for up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05954312

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Vividion Therapeutics, Inc.
~290 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:VVD-130037DocetaxelPaclitaxelPembrolizumab

At a glance

Recruiting sites
26 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 (Dose Escalation): Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period
Measured over Part 1: Single Agent and Docetaxel/Pembrolizumab Combination Therapy: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days] and Part 1: Paclitaxel Combination Therapy: From Day 1 to Day 28 of Cycle 1 [cycle length=28 days]
+1 more outcome measured

Conditions

Advanced Solid Tumors

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Esophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

26 sites across 7 states
South Korea9
Spain9
Florida3
Texas2
Minnesota1
Tennessee1
Virginia1

Who to contact

Vividion Clinical Trial Call Center
[email protected]
(858) 345-9752
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

Participant is known to have a mutation that has no expectation of benefit from VVD-130037. Current such mutations include the following:
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:
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)

What this trial measures

  • Part 1 (Dose Escalation): Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation PeriodPart 1: Single Agent and Docetaxel/Pembrolizumab Combination Therapy: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days] and Part 1: Paclitaxel Combination Therapy: From Day 1 to Day 28 of Cycle 1 [cycle length=28 days]

    Incidence and severity of DLTs will be assessed per DLT criteria set forth in the protocol based on adverse events (AEs) evaluated per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  • Part 2 (Dose Expansion): Number of Participants With AEs, Serious Adverse Events (SAEs), and Clinical Laboratory AbnormalitiesUp to approximately 4 years