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Study of VVD-159642 for Advanced Solid Tumors

This study is testing a new drug called VVD-159642 in people with advanced solid tumors. Researchers want to see how safe VVD-159642 is and how well your body handles it, both alone and when combined with sotorasib or trametinib. You might be able to join if you have certain advanced solid tumors like pancreatic, colorectal, or non-small cell lung cancer, and your tumor has specific genetic changes (like KRAS or NRAS). The study will look at side effects and how your vital signs (like heart rate and blood pressure) change. This is a "first-in-human" study, meaning it's one of the first times this drug is being tested in people. The study aims to enroll 220 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a "first-in-human" study and plans to enroll 220 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in Part 2 of the study will be monitored for adverse events and changes in vital signs for up to approximately 29 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06804824

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Vividion Therapeutics, Inc.
~220 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:VVD-159642SotorasibTrametinib

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs)
Measured over From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]
+3 more outcomes measured

Conditions

Advanced Solid Tumors

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Where it's being run

9 sites across 6 states
Texas4
Michigan1
Utah1
Virginia1
South Australia1
Western Australia1

Who to contact

Vividion Clinical Trial Call Center
[email protected]
858-345-9752
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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).

What this trial measures

  • Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs)From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]
  • Part 2: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to approximately 29 months
  • Part 2: Incidence and Severity of Clinically Significant Changes in Vital SignsUp to approximately 29 months
  • Part 2: Incidence and Severity of Clinically Significant Changes in Laboratory EvaluationsUp to approximately 29 months