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PI3K Inhibitor
VVD-159642 for Solid Tumors
Austin, TX
Phase 1
Recruiting
Research Sponsored by Vividion Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Able to take oral medications.
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 29 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety, effectiveness, and how the body processes a new drug called VVD-159642 in patients with advanced solid tumors. They will also see how well this drug works
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Who is the study for?
This trial is for adults with advanced solid tumors that can't be surgically removed or have spread, and who are in good physical condition (ECOG ≤1). They must have a type of tumor with specific genetic changes (RAS alterations or EGFR/HER2 overexpression) and should be able to take pills. People with pancreatic, colorectal, lung cancer, or any RAS-altered solid tumor are especially considered.Check my eligibility
What is being tested?
The study tests VVD-159642 alone and combined with sotorasib or trametinib. It's a first-in-human trial focusing on safety, how the body processes the drug (PK), its effects on the body (PD), and initial effectiveness against various advanced solid tumors.See study design
What are the potential side effects?
Potential side effects include those common to cancer treatments such as nausea, fatigue, liver issues but also specific ones related to these drugs like skin rash from trametinib and potential blood sugar changes due to PI3Kα inhibition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills by mouth.
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My cancer is confirmed and has specific genetic changes.
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My cancer is confirmed to be advanced and cannot be removed by surgery.
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I am fully active or can carry out light work.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 29 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 29 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Part 1: Recommended Dose for Expansion (RDE) of VVD-159642 as a Single Agent
Part 2: Disease Control Rate (DCR)
Part 2: Duration of Response (DoR)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 2: Dose Expansion (Cohort C): VVD-159642 + TrametinibExperimental Treatment2 Interventions
Participants will receive VVD-159642 at RDE orally, daily in combination with trametinib, in 21-day treatment cycles after a safety run-in.
Group II: Part 2: Dose Expansion (Cohort B): VVD-159642 + SotorasibExperimental Treatment2 Interventions
Participants will receive VVD-159642 at RDE orally, daily in combination with sotorasib, in 21-day treatment cycles after a safety run-in.
Group III: Part 2: Dose Expansion (Cohort A): VVD-159642 Single AgentExperimental Treatment1 Intervention
Participants will receive VVD-159642 at the recommended dose for expansion (RDE), orally, daily in 21-day treatment cycles during Part 2.
Group IV: Part 1: Dose Escalation: VVD-159642 Single AgentExperimental Treatment1 Intervention
Participants will receive ascending doses of VVD-159642, orally, daily in 21-day treatment cycles during Part 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotorasib
2021
Completed Phase 1
~370
Trametinib
2014
Completed Phase 2
~1580
Find a Location
Closest Location:NEXT Austin· Austin, TX
Who is running the clinical trial?
Vividion Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
560 Total Patients Enrolled