AzTrials
AzTrials

Advanced Solid TumorsPhase 1NCT06804824

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

A Phase 1 study testing VVD-159642, Sotorasib and Trametinib in people with Advanced Solid Tumors, run by Vividion Therapeutics, Inc. at 9 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
VVD-159642, Sotorasib and Trametinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
9 sitesin 2 countries
Study dates
25 Feb 2025to 1 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Vividion Clinical Trial Call Center contact

858-345-9752

clinicaltrials@vividion.com

9 sites in 2 countries

United States7 sites, 7 recruiting

  • NEXT Austin

    Austin, Texas, 78758

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • START Mid West

    Grand Rapids, Michigan, 49546

    Recruiting

  • NEXT Dallas

    Irving, Texas, 75039

    Recruiting

  • START Mountain

    Ogden, Utah, 84401

    Recruiting

  • START San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • NEXT San Antonio

    San Antonio, Texas, 78299

    Recruiting

Other trials in United States

Australia2 sites, 2 recruiting

  • Clinical Research South Australia (CRSA)

    Adelaide, South Australia, 5000

    Recruiting

  • Linear Clinical

    Nedlands, Western Australia, 6009

    Recruiting

Other trials in Australia

About this study

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

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.

Being tested
VVD-159642, Sotorasib, Trametinib
Keywords
RAS, PI3K, KRAS, MEK, Phase I, solid tumors, KRAS G12C, HER2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VVD-159642Drug

    Oral capsules

  • SotorasibDrug

    Oral tablets

  • TrametinibDrug

    Oral tablets

Study groups in NCT06804824
Study groupRoleWhat they receive
Part 1: Dose Escalation: VVD-159642 Single AgentExperimentalParticipants will receive ascending doses of VVD-159642, orally, daily in 21-day treatment cycles during Part 1.
Receives: Drug: VVD-159642
Part 2: Dose Expansion (Cohort A): VVD-159642 Single AgentExperimentalParticipants will receive VVD-159642 at the recommended dose for expansion (RDE), orally, daily in 21-day treatment cycles during Part 2.
Receives: Drug: VVD-159642
Part 2: Dose Expansion (Cohort B): VVD-159642 + SotorasibExperimentalParticipants will receive VVD-159642 at RDE orally, daily in combination with sotorasib, in 21-day treatment cycles after a safety run-in.
Receives: Drug: VVD-159642; Drug: Sotorasib
Part 2: Dose Expansion (Cohort C): VVD-159642 + TrametinibExperimentalParticipants will receive VVD-159642 at RDE orally, daily in combination with trametinib, in 21-day treatment cycles after a safety run-in.
Receives: Drug: VVD-159642; Drug: Trametinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs)

    Measured: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]

  2. Part 2: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to approximately 29 months

  3. Part 2: Incidence and Severity of Clinically Significant Changes in Vital Signs

    Measured: Up to approximately 29 months

  4. Part 2: Incidence and Severity of Clinically Significant Changes in Laboratory Evaluations

    Measured: Up to approximately 29 months

Secondary outcomes (9)

  1. Part 1: Recommended Dose for Expansion (RDE) of VVD-159642 as a Single Agent

    The RDE will be based on safety, tolerability, PK, and preliminary anti-tumor activity of VVD-159642 as a single agent during the dose escalation phase.

    Measured: Up to approximately 29 months

  2. Part 2: Recommended Phase 2 Dose (RP2D) of VVD-159642 as a Single Agent and in Combination with Sotorasib and Trametinib

    The RP2D will be based on safety, tolerability, PK and preliminary anti-tumor activity of VVD-159642 as single agent, and in combination with sotorasib and trametinib during Part 2.

    Measured: Up to approximately 29 months

  3. Part 2: Overall Response Rate (ORR)

    ORR is defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.

    Measured: Up to approximately 29 months

  4. Part 2: Duration of Response (DoR)

    DOR is defined as the time from initial response of CR or PR to progressive disease or death, whichever comes first per RECIST version 1.1 by investigator assessment.

    Measured: Up to approximately 29 months

  5. Part 2: Progression-free Survival (PFS)

    PFS is defined as the time from the date of randomization to the time of confirmed disease progression or death, whichever occurs first per RECIST version 1.1 by investigator assessment.

    Measured: Up to approximately 29 months

  6. Part 2: Disease Control Rate (DCR)

    DCR is defined as the percentage of participants achieving CR or PR, or stable disease (SD) per RECIST version 1.1 by investigator assessment.

    Measured: Up to approximately 29 months

  7. Parts 1 and 2: Area Under the Plasma Concentration-time Curve (AUC) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib

    Measured: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)

  8. Parts 1 and 2: Maximum Plasma Concentration (Cmax) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib

    Measured: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)

  9. Parts 1 and 2: Half-life (t1/2) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib

    Measured: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start25 Feb 2025
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06804824
Sponsor's protocol ID
VVD-159642-01
Status last verified
Mar 2026
First submitted
27 Jan 2025
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VVD-159642, Sotorasib and Trametinib in people with Advanced Solid Tumors, run by Vividion Therapeutics, Inc. at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vividion Clinical Trial Call Center (858-345-9752, clinicaltrials@vividion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06804824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in