Evaluating the safety of VVD-130850 in patients with advanced tumors
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
PHASE1 · Vividion Therapeutics, Inc. · NCT06188208
This study is testing a new treatment called VVD-130850 to see if it's safe for people with advanced tumors, both on its own and when combined with another drug.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vividion Therapeutics, Inc. (industry) |
| Drugs / interventions | pembrolizumab, immunotherapy |
| Locations | 19 sites (Sarasota, Florida and 18 other locations) |
| Trial ID | NCT06188208 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of VVD-130850, a small molecule treatment, in patients with advanced solid tumors and hematologic cancers. It will assess the drug both as a standalone treatment and in combination with pembrolizumab, a checkpoint inhibitor. The study aims to gather data on pharmacokinetics and pharmacodynamics to understand how the drug works in the body. Participants will be closely monitored for any adverse effects and overall response to the treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with confirmed metastatic or unresectable solid tumors or advanced non-Hodgkin's lymphoma who have limited treatment options.
Not a fit: Patients with immunodeficiency or those currently receiving immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that are difficult to treat.
How similar studies have performed: Other studies involving similar small molecule treatments and checkpoint inhibitors have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Sarasota, Florida and 18 other locations
- Florida Cancer Specialists — Sarasota, Florida, United States (RECRUITING)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (RECRUITING)
- NEXT Austin — Austin, Texas, United States (RECRUITING)
- MDACC — Houston, Texas, United States (RECRUITING)
- NEXT Dallas — Irving, Texas, United States (RECRUITING)
- NEXT San Antonio — San Antonio, Texas, United States (RECRUITING)
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (RECRUITING)
- NEXT Virginia — Fairfax, Virginia, United States (RECRUITING)
- Blacktown Hospital — Blacktown, New South Wales, Australia (RECRUITING)
- Orange Health Service — Orange, New South Wales, Australia (RECRUITING)
- Gold Coast University Hospital — Southport, Queensland, Australia (RECRUITING)
- Cancer Research South Australia — Adelaide, Australia (RECRUITING)
- ICON Cancer Research — South Brisbane, Australia (RECRUITING)
- START Barcelona Hospital HM Nou Delfos — Barcelona, Spain (RECRUITING)
- Vall d'Hebron — Barcelona, Spain (ACTIVE_NOT_RECRUITING)
- Hospital Universitario 12 de Octubre — Madrid, Spain (ACTIVE_NOT_RECRUITING)
- NEXT Madrid — Madrid, Spain (RECRUITING)
- START Madrid CIOCC — Madrid, Spain (RECRUITING)
- Start Madrid-FJD, Hospital Fundacion Jimenez Diaz — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Vividion Clinical Trial Call Center
- Email: clinicaltrials@vividion.com
- Phone: (858) 345-9752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumors, Advanced Hematologic Tumors, VVD-130850, Phase I, First in Human, Cancer, small molecule, STAT3