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

NCT06188208
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Terminated
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Participants
132
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Lead sponsor
Vividion Therapeutics, Inc.
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Start date
2024-01-05
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Number of sites
20
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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.
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Short title
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Terminated
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Phase
Phase 1
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Study type
Interventional
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Reason stopped
The study has ended
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Completion date
2026-02-20
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First posted
2024-01-03
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Registry last updated
2026-06-12
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Primary completion date
2026-02-20
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Start date
2024-01-05
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Actual participants
132
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Participants
132
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
20
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Vividion Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06188208
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ClinicalTrials.gov ID
NCT06188208
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: From Day 1 to Day 21 of Cycle 1 [cycle length=21 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.

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

    Timeframe: Up to approximately 4 years

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

    Timeframe: Up to approximately 4 years

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

    Timeframe: Up to approximately 4 years

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

    Timeframe: Up to approximately 4 years

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

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

    Timeframe: Up to approximately 4 years

    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.

  3. Dose Expansion: Overall Response Rate (ORR)

    Timeframe: Up to approximately 4 years

    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.

  4. Dose Expansion: Duration of Response (DoR)

    Timeframe: Up to approximately 4 years

    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.

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

    Timeframe: Up to approximately 4 years

    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.

  6. Dose Expansion: Disease Control Rate (DCR)

    Timeframe: Up to approximately 4 years

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

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

    Timeframe: 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

    Timeframe: 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

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).

  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

  3. Adequate organ and bone marrow function as defined in the protocol.

  4. 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.

  5. Measurable disease by RECIST version 1.1 as assessed by the Investigator.

Key Exclusion Criteria:

  1. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.

  2. Prior allogeneic transplantation.

  3. History of cardiac diseases as defined in detail in the protocol.

  4. Clinically significant infection or any eye infection.

  5. Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).

  6. 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).
Sources for eligibility
clinicaltrials.gov

  • California Research InstituteLos Angeles, United States
  • Florida Cancer SpecialistsSarasota, United States
  • Sarah Cannon Research InstituteNashville, United States
  • NEXT AustinAustin, United States
  • MDACCHouston, United States
  • NEXT DallasIrving, United States
  • NEXT San AntonioSan Antonio, United States
  • University of Utah Huntsman Cancer InstituteSalt Lake City, United States
  • NEXT VirginiaFairfax, United States
  • Blacktown HospitalBlacktown, Australia
  • Orange Health ServiceOrange, Australia
  • Gold Coast University HospitalSouthport, Australia
  • Cancer Research South AustraliaAdelaide, Australia
  • ICON Cancer ResearchSouth Brisbane, Australia
  • START Barcelona Hospital HM Nou DelfosBarcelona, Spain
  • Vall d'HebronBarcelona, Spain
  • Hospital Universitario 12 de OctubreMadrid, Spain
  • NEXT MadridMadrid, Spain
  • START Madrid CIOCCMadrid, Spain
  • Start Madrid-FJD, Hospital Fundacion Jimenez DiazMadrid, Spain
Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-508386-32-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)