A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors
NCT ID: NCT06188208
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
125 participants
INTERVENTIONAL
2024-01-05
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation: VVD-130850 Single Agent
Participants will receive ascending doses of VVD-130850, orally, once daily in 21-day treatment cycles during the dose escalation phase.
VVD-130850
Oral tablets
Dose Escalation: VVD-130850 + Pembrolizumab Combination Therapy
Participants 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.
VVD-130850
Oral tablets
Pembrolizumab
IV infusion
Dose Expansion: VVD-130850 Single Agent
Participants will receive VVD-130850 at recommended dose for expansion (RDE), orally, once daily in 21-day treatment cycles during the dose expansion phase.
VVD-130850
Oral tablets
Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy
Participants 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.
VVD-130850
Oral tablets
Pembrolizumab
IV infusion
Interventions
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VVD-130850
Oral tablets
Pembrolizumab
IV infusion
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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Vividion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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California Research Institute
Los Angeles, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
NEXT Austin
Austin, Texas, United States
MDACC
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
NEXT San Antonio
San Antonio, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Blacktown Hospital
Blacktown, New South Wales, Australia
Orange Health Service
Orange, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Cancer Research South Australia
Adelaide, , Australia
ICON Cancer Research
South Brisbane, , Australia
START Barcelona Hospital HM Nou Delfos
Barcelona, , Spain
Vall d'Hebron
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
NEXT Madrid
Madrid, , Spain
START Madrid CIOCC
Madrid, , Spain
Start Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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Other Identifiers
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2023-508386-32-00
Identifier Type: OTHER
Identifier Source: secondary_id
VVD-130850-01
Identifier Type: -
Identifier Source: org_study_id
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