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

NCT ID: NCT06804824

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2027-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors

Keywords

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RAS PI3K KRAS MEK Phase I solid tumors KRAS G12C HER2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VVD-159642

Intervention Type DRUG

Oral capsules

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.

Group Type EXPERIMENTAL

VVD-159642

Intervention Type DRUG

Oral capsules

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.

Group Type EXPERIMENTAL

VVD-159642

Intervention Type DRUG

Oral capsules

Sotorasib

Intervention Type DRUG

Oral tablets

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.

Group Type EXPERIMENTAL

VVD-159642

Intervention Type DRUG

Oral capsules

Trametinib

Intervention Type DRUG

Oral tablets

Interventions

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VVD-159642

Oral capsules

Intervention Type DRUG

Sotorasib

Oral tablets

Intervention Type DRUG

Trametinib

Oral tablets

Intervention Type DRUG

Eligibility Criteria

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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.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vividion Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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START Mid West

Grand Rapids, Michigan, United States

Site Status RECRUITING

NEXT Austin

Austin, Texas, United States

Site Status RECRUITING

NEXT Dallas

Irving, Texas, United States

Site Status RECRUITING

START San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

NEXT San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

START Mountain

Ogden, Utah, United States

Site Status RECRUITING

NEXT Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Clinical Research South Australia (CRSA)

Adelaide, South Australia, Australia

Site Status RECRUITING

Linear Clinical

Nedlands, Western Australia, Australia

Site Status RECRUITING

Countries

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United States Australia

Central Contacts

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Vividion Clinical Trial Call Center

Role: CONTACT

Phone: 858-345-9752

Email: [email protected]

Other Identifiers

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VVD-159642-01

Identifier Type: -

Identifier Source: org_study_id