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Advanced Solid TumorsPhase 1NCT05954312

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

A Phase 1 study testing VVD-130037, Docetaxel and Paclitaxel in people with Advanced Solid Tumors, run by Vividion Therapeutics, Inc. at 26 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
VVD-130037, Docetaxel and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
26 sitesin 3 countries
Study dates
28 Jul 2023to 28 Feb 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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:
  • 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)

Trial locations and contacts

26 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Vividion Clinical Trial Call Center contact

(858) 345-9752

clinicaltrials@vividion.com

26 sites in 3 countries

South Korea9 sites, 9 recruiting

  • National Cancer Center

    Goyang

    Recruiting

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

    Goyang

    Vividion Call Center, +1 8583459752

    Recruiting

  • Gachon University Gil Medical Center

    Incheon

    Recruiting

  • Seoul National University; Bundang Hospital

    Seongnam

    Recruiting

  • Asan Medical Center

    Seoul

    Recruiting

  • Samsung Medical Center

    Seoul

    Recruiting

  • Seoul National University Hospital

    Seoul

    Recruiting

  • Severance Hospital; Yonsei University Health System

    Seoul

    Recruiting

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

    Suwon

    Recruiting

Other trials in South Korea

Spain9 sites, 9 recruiting

  • Hospital Vall d'Hebron

    Barcelona

    Recruiting

  • START Barcelona Hospital HM Nou Delfos

    Barcelona

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid

    Recruiting

  • NEXT Madrid

    Madrid

    Recruiting

  • START Madrid CIOCC

    Madrid

    Recruiting

  • Start Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid

    Recruiting

  • Clinica Universitaria de Navarra

    Pamplona

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia

    Recruiting

Other trials in Spain

United States8 sites, 8 recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • MDACC

    Houston, Texas, 77030

    Recruiting

  • NEXT Dallas

    Irving, Texas, 75039

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of VVD-130037, a Kelch-like ECH Associated Protein 1 (KEAP1) Activator, in Participants With Advanced Solid Tumors

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.

Being tested
VVD-130037, Docetaxel, Paclitaxel, Pembrolizumab
Keywords
VVD-130037, First-in-Human, KEAP1, NRF2, Cancer, small molecule, squamous cell histology, esophageal adenocarcinoma
Medical subject headings
Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05954312
Study groupRoleWhat they receive
Part 1 (Dose Escalation): VVD-130037 Single AgentExperimentalParticipants will receive ascending doses of VVD-130037, orally, once or twice daily in 21-day treatment cycles during Part 1.
Receives: Drug: VVD-130037
Part 1 (Dose Escalation): VVD-130037 and Docetaxel Combination TherapyExperimentalParticipants will receive ascending doses of VVD-130037, orally, once or twice daily along with docetaxel intravenous (IV) infusion administered once every 3 weeks in 21-day treatment cycles during Part 1.
Receives: Drug: VVD-130037; Drug: Docetaxel
Part 1 (Dose Escalation): VVD-130037 and Paclitaxel Combination TherapyExperimentalParticipants will receive ascending doses of VVD-130037, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 1.
Receives: Drug: VVD-130037; Drug: Paclitaxel
Part 2 (Dose Expansion): VVD-130037 Single AgentExperimentalParticipants will receive VVD-130037 at the recommended dose for expansion (RDE), orally, once or twice daily in 21-day treatment cycles during Part 2.
Receives: Drug: VVD-130037
Part 2 (Dose Expansion): VVD-130037 and Docetaxel Combination TherapyExperimentalParticipants will receive VVD-130037 at the RDE, orally, once or twice daily along with docetaxel IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2.
Receives: Drug: VVD-130037; Drug: Docetaxel
Part 2 (Dose Expansion): VVD-130037 and Paclitaxel Combination TherapyExperimentalParticipants will receive VVD-130037 at the RDE, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 2.
Receives: Drug: VVD-130037; Drug: Paclitaxel
Experimental: Part 2 (Dose Expansion): VVD-130037 and Pembrolizumab Combination TherapyExperimentalParticipants will first be evaluated in a safety-run in cohort to determine the RDE(s). Participants will then receive VVD-130037 at the RDE, orally, once or twice daily along with pembrolizumab IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2.
Receives: Drug: VVD-130037; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 (Dose Escalation): Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period

    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.

    Measured: 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]

  2. Part 2 (Dose Expansion): Number of Participants With AEs, Serious Adverse Events (SAEs), and Clinical Laboratory Abnormalities

    Measured: Up to approximately 4 years

Secondary outcomes (10)

  1. Part 1 (Dose Escalation): Number of Participants With AEs, SAEs, and Clinical Laboratory Abnormalities

    Measured: Up to approximately 4 years

  2. Part 2 (Dose Expansion): Recommended Phase 2 Dose (RP2D) of VVD-130037 as a Single Agent and in Combination with Docetaxel, Paclitaxel, or Pembrolizumab

    The RP2D will be based on safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of VVD-130037 as single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab during Part 2.

    Measured: Up to approximately 4 years

  3. Part 2 (Dose Expansion): Overall Response Rate (ORR)

    ORR is defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.

    Measured: Up to approximately 4 years

  4. Part 2 (Dose Expansion): Duration of Response (DOR)

    DOR is defined as the time from initial response of CR or PR to progressive disease or death, whichever comes first per RECIST version 1.1 by investigator assessment.

    Measured: Up to approximately 4 years

  5. Part 2 (Dose Expansion): Progression-free Survival (PFS)

    PFS is defined as the time from the date of randomization to the time of confirmed disease progression or death, whichever occurs first per RECIST version 1.1 by investigator assessment.

    Measured: Up to approximately 4 years

  6. Part 2 (Dose Expansion): Disease Control Rate (DCR)

    DCR is defined as the percentage of participants achieving CR or PR, or stable disease (SD) per RECIST version 1.1 by investigator assessment.

    Measured: Up to approximately 4 years

  7. Parts 1 and 2 (Dose Escalation and Expansion): Area Under the Plasma Concentration-time Curve (AUC) of VVD-130037

    Measured: Parts 1 and 2: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days for Single Agent and Docetaxel/Pembrolizumab Combination Therapy and cycle length=28 days for Paclitaxel Combination Therapy)

  8. Parts 1 and 2 (Dose Escalation and Expansion): Maximum Observed Concentration (Cmax) of VVD-130037

    Measured: Parts 1 and 2: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days for Single Agent and Docetaxel/Pembrolizumab Combination Therapy and cycle length=28 days for Paclitaxel Combination Therapy)

  9. Parts 1 and 2 (Dose Escalation and Expansion): Apparent Terminal Half-life (T1/2) of VVD-130037

    Measured: Parts 1 and 2: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days for Single Agent and Docetaxel/Pembrolizumab Combination Therapy and cycle length=28 days for Paclitaxel Combination Therapy)

  10. Parts 1 and 2 (Dose Escalation and Expansion): QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters

    Number of participants with changes in QT/QTc interval and other ECG parameters will be assessed.

    Measured: Parts 1 and 2: Up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2023
  2. Study start28 Jul 2023
  3. Primary completion31 Aug 2030 (estimated)
  4. Study completion28 Feb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05954312
Sponsor's protocol ID
VVD-130037-001
Other IDs
2023-506199-28-00, 2023
Status last verified
May 2026
First submitted
12 Jul 2023
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roy N, Wyseure T, Lo IC, Lu J, Eissler CL, Bernard SM, Bok I, Snead AN, Parker A, Lo UG, Green JC, Inloes J, Jacinto SR, Kuenzi B, Pariollaud M, Negri K, Le K, Horning BD, Ibrahim N, Grabow S, Panda H, Bhatt DP, Wilkerson EM, Saeidi S, Zolkind P, Rush Z, Williams HN, Walton E, Pastuszka MK, Sigler JJ, Tran E, Hee K, McLaughlin J, Ambrus-Aikelin G, Pollock J, Abraham RT, Kinsella TM, Simon GM, Major MB, Weinstein DS, Patricelli MP. A Covalent Allosteric Molecular Glue Suppresses NRF2-Dependent Cancer Growth. Cancer Discov. 2026 May 1;16(5):953-975. doi: 10.1158/2159-8290.CD-25-1187.

    PubMed 41417010

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VVD-130037, Docetaxel and Paclitaxel in people with Advanced Solid Tumors, run by Vividion Therapeutics, Inc. at 26 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in South Korea, Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vividion Clinical Trial Call Center ((858) 345-9752, clinicaltrials@vividion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 (Dose Escalation): Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period (time frame: 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]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05954312, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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