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Advanced Solid TumorsPhase 1NCT06188208

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors

A Phase 1 study testing VVD-130850 and Pembrolizumab in people with Advanced Solid Tumors and Advanced Hematologic Tumors, run by Vividion Therapeutics, Inc. at 20 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VVD-130850 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
20 sitesin 3 countries
Study dates
5 Jan 2024to 20 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 or advanced non-Hodgkin's lymphoma (NHL).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  • Adequate organ and bone marrow function as defined in the protocol.
  • For Combination Therapy Expansion:
  • Serine/threonine kinase 11/ liver kinase B1 (STK11/LKB1) mutated non-small cell lung cancer (NSCLC) as assessed by historical (local) test.
  • Must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor (CPI). These therapies could have been given in the same line of therapy or different lines of therapy.
  • Measurable disease by RECIST version 1.1 as assessed by the Investigator.

Who cannot join

  • Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
  • Prior allogeneic transplantation.
  • History of cardiac diseases as defined in detail in the protocol.
  • Clinically significant infection or any eye infection.
  • Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
  • Combination Therapy Expansion:
  • Known hypersensitivity or contraindication to pembrolizumab or any of its components.
  • Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation with the exception of the history of immunotherapy-related endocrinopathy controlled with ongoing medical management (e.g., hypothyroidism, adrenal insufficiency, diabetes).

Trial locations and contacts

20 sites in 3 countries.

20 sites in 3 countries

United States9 sites

  • NEXT Austin

    Austin, Texas, 78758

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • MDACC

    Houston, Texas, 77030

  • NEXT Dallas

    Irving, Texas, 75039

  • California Research Institute

    Los Angeles, California, 90027

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • NEXT San Antonio

    San Antonio, Texas, 78299

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

Spain6 sites

  • START Barcelona Hospital HM Nou Delfos

    Barcelona

  • Vall d'Hebron

    Barcelona

  • Hospital Universitario 12 de Octubre

    Madrid

  • NEXT Madrid

    Madrid

  • START Madrid CIOCC

    Madrid

  • Start Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid

Other trials in Spain

Australia5 sites

  • Cancer Research South Australia

    Adelaide

  • Blacktown Hospital

    Blacktown, New South Wales

  • Orange Health Service

    Orange, New South Wales

  • ICON Cancer Research

    South Brisbane

  • Gold Coast University Hospital

    Southport, Queensland

Other trials in Australia

About this study

Official title: A Phase 1, Open-Label, 2-Part, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of the STAT3 Inhibitor VVD-130850 as Single Agent and in Combination With Checkpoint Inhibition in Participants With Advanced Solid and Hematologic Tumors

A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors.

Being tested
VVD-130850, Pembrolizumab
Keywords
VVD-130850, Phase I, First in Human, Cancer, small molecule, STAT3, NSCLC, STK11, LKB1, immunosuppression, Checkpoint inhibitor, PD-1
Medical subject headings
Neoplasms

What participants receive

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

Study groups in NCT06188208
Study groupRoleWhat they receive
Dose Escalation: VVD-130850 Single AgentExperimentalParticipants will receive ascending doses of VVD-130850, orally, once daily in 21-day treatment cycles during the dose escalation phase.
Receives: Drug: VVD-130850
Dose Escalation: VVD-130850 + Pembrolizumab Combination TherapyExperimentalParticipants will receive ascending doses of VVD-130850, orally, once daily, along with pembrolizumab intravenous (IV) infusion, every 3 weeks (Q3W) in 21-day treatment cycles during the dose escalation phase.
Receives: Drug: VVD-130850; Drug: Pembrolizumab
Dose Expansion: VVD-130850 Single AgentExperimentalParticipants will receive VVD-130850 at recommended dose for expansion (RDE), orally, once daily in 21-day treatment cycles during the dose expansion phase.
Receives: Drug: VVD-130850
Dose Expansion: VVD-130850 + Pembrolizumab Combination TherapyExperimentalParticipants will receive VVD-130850 at RDE orally, once daily along with pembrolizumab IV infusion, Q3W in 21-day treatment cycles during the dose expansion phase.
Receives: Drug: VVD-130850; Drug: Pembrolizumab

What is being measured

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

  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: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]

  2. Dose Expansion: Number of Participants with AEs and Serious Adverse Events (SAEs)

    Measured: Up to approximately 4 years

  3. Dose Expansion: Number of Participants with Clinically Significant Changes in Vital Signs

    Measured: Up to approximately 4 years

  4. Dose Expansion: Number of Participants with Clinically Significant Changes in Laboratory Evaluations

    Measured: Up to approximately 4 years

Secondary outcomes (9)

  1. Dose Escalation: 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: Up to approximately 4 years

  2. Dose Escalation: Recommended Dose for Expansion (RDE) of VVD-130850 as a Single Agent and in Combination with Pembrolizumab

    The RDE will be based on safety, pharmacokinetics, pharmacodynamic biomarker data, and preliminary anti-tumor activity collected during the study as defined by the safety review committee.

    Measured: Up to approximately 4 years

  3. 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) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.

    Measured: Up to approximately 4 years

  4. 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. 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. 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. Dose Escalation and Expansion: Area Under the Plasma Concentration-time Curve (AUC) of VVD-130850

    Measured: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)

  8. Dose Escalation and Expansion: Maximum Plasma Concentration (Cmax) of VVD-130850

    Measured: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)

  9. Dose Escalation and Expansion: Apparent Terminal Half-life (t1/2) of VVD-130850

    Measured: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)

Timeline

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

  1. First posted3 Jan 2024
  2. Study start5 Jan 2024
  3. Primary completion20 Feb 2026
  4. Study completion20 Feb 2026

Why it stopped: The study has ended

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06188208
Sponsor's protocol ID
VVD-130850-01
Other IDs
2023-508386-32-00, 2023
Status last verified
Jun 2026
First submitted
13 Dec 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VVD-130850 and Pembrolizumab in people with Advanced Solid Tumors and Advanced Hematologic Tumors, run by Vividion Therapeutics, Inc. at 20 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Spain, Australia. 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?

The study was stopped early (reason given: The study has ended). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period (time frame: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]). The study lists 4 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 NCT06188208.

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 12 Jun 2026.

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