RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/1b, Open-Label, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-159642, a RAS-PI3Kα Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors

Quick Facts

Study Start:2025-02-25
Study Completion:2027-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06804824

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Have histologically or cytologically confirmed metastatic or unresectable solid tumors.
  3. * Measurable disease by RECIST version 1.1 as assessed by the investigator.
  4. * Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  5. * Adequate bone marrow, kidney, and liver function as defined in the protocol.
  6. * Able to take oral medications.
  1. * Active central nervous system (CNS) malignancies.
  2. * History of cardiac diseases as defined in detail in the protocol.
  3. * Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
  4. * 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.
  5. * Active hepatitis B infection \[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\].
  6. * 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).

Contacts and Locations

Study Contact

Vividion Clinical Trial Call Center
CONTACT
858-345-9752
clinicaltrials@vividion.com

Study Locations (Sites)

NEXT Austin
Austin, Texas, 78758
United States
NEXT Dallas
Irving, Texas, 75039
United States
NEXT San Antonio
San Antonio, Texas, 78299
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Vividion Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-25
Study Completion Date2027-08-01

Study Record Updates

Study Start Date2025-02-25
Study Completion Date2027-08-01

Terms related to this study

Keywords Provided by Researchers

  • RAS
  • PI3K
  • KRAS
  • MEK
  • Phase I
  • solid tumors
  • KRAS G12C
  • HER2

Additional Relevant MeSH Terms

  • Advanced Solid Tumors