Recruiting
Phase 1

VVD-159642

Sponsor:

Vividion Therapeutics, Inc.

Code:

NCT06804824

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VVD-159642

Sotorasib

Trametinib

Study Details

Brief summary:

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

Advanced Solid Tumors

Study ID

NCT06804824

Start date

Feb 25, 2025

Status verified date

Mar, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • 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 Exclusion Criteria:

  • 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).

Study Design

Enrollment

220 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Dose Escalation: VVD-159642 Single Agent

Participants will receive ascending doses of VVD-159642, orally, daily in 21-day treatment cycles during Part 1.

experimental: Part 2: Dose Expansion (Cohort A): VVD-159642 Single Agent

Participants will receive VVD-159642 at the recommended dose for expansion (RDE), orally, daily in 21-day treatment cycles during Part 2.

experimental: Part 2: Dose Expansion (Cohort B): VVD-159642 + Sotorasib

Participants will receive VVD-159642 at RDE orally, daily in combination with sotorasib, in 21-day treatment cycles after a safety run-in.

experimental: Part 2: Dose Expansion (Cohort C): VVD-159642 + Trametinib

Participants will receive VVD-159642 at RDE orally, daily in combination with trametinib, in 21-day treatment cycles after a safety run-in.

Interventions

VVD-159642

Oral capsules

Sotorasib

Oral tablets

Trametinib

Oral tablets

Primary outcome measure

  • Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs) [ Time Frame: 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) [ Time Frame: Up to approximately 29 months ]
  • Part 2: Incidence and Severity of Clinically Significant Changes in Vital Signs [ Time Frame: Up to approximately 29 months ]
  • Part 2: Incidence and Severity of Clinically Significant Changes in Laboratory Evaluations [ Time Frame: Up to approximately 29 months ]

Central Contacts and Locations

Central contacts

Vividion Clinical Trial Call Center

858-345-9752clinicaltrials@vividion.com

Locations

START Mid West

Recruiting

Grand Rapids, Michigan, United States, 49546

NEXT Austin

Recruiting

Austin, Texas, United States, 78758

NEXT Dallas

Recruiting

Irving, Texas, United States, 75039

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

NEXT San Antonio

Recruiting

San Antonio, Texas, United States, 78299

START Mountain

Recruiting

Ogden, Utah, United States, 84401

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Vividion Therapeutics, Inc.

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vividion Therapeutics, Inc. on 2026-03-18.