Actively Recruiting
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors
Led by Vividion Therapeutics, Inc. · Updated on 2026-03-18
220
Participants Needed
9
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
CONDITIONS
Official Title
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
Key
- For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration [Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)] as per local /historical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local/historical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry [IHC] 3+ or IHC 2+/fluorescence in situ hybridization [FISH] positive) as per local/historical testing.
- Have histologically or cytologically confirmed metastatic or unresectable solid tumors.
- Measurable disease by RECIST version 1.1 as assessed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Adequate bone marrow, kidney, and liver function as defined in the protocol.
- Able to take oral medications.
Key
You will not qualify if you...
- Active central nervous system (CNS) malignancies.
- History of cardiac diseases as defined in detail in the protocol.
- Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
- History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study.
- Active hepatitis B infection [positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)].
- Active hepatitis C infection (positive anti-hepatitis C virus [HCV] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay).
AI-Screening
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Trial Site Locations
Total: 9 locations
1
START Mid West
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
2
NEXT Austin
Austin, Texas, United States, 78758
Actively Recruiting
3
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
4
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
5
NEXT San Antonio
San Antonio, Texas, United States, 78299
Actively Recruiting
6
START Mountain
Ogden, Utah, United States, 84401
Actively Recruiting
7
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
8
Clinical Research South Australia (CRSA)
Adelaide, South Australia, Australia, 5000
Actively Recruiting
9
Linear Clinical
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
V
Vividion Clinical Trial Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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