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Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy for Cancer

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
Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL)
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of a drug called VVD-130850 in people with advanced cancer. It will look at how the drug works on its own and when combined with another treatment

Who is the study for?
This trial is for individuals with advanced solid tumors or blood cancers who have not responded to standard treatments. Participants must be adults, able to give consent, and meet specific health criteria.Check my eligibility
What is being tested?
The study tests VVD-130850 alone and combined with Pembrolizumab (a checkpoint inhibitor) to assess safety, how the body processes it, and its effects on cancer cells in patients with advanced tumors.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with cancer therapies such as fatigue, nausea, immune-related issues due to Pembrolizumab's action on the immune system, and other drug-specific adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is 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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My NSCLC has a specific mutation (STK11/LKB1).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period
Dose Expansion: Number of Participants with AEs and Serious Adverse Events (SAEs)
Dose Expansion: Number of Participants with Clinically Significant Changes in Laboratory Evaluations
+1 more
Secondary outcome measures
Dose Escalation and Expansion: Apparent Terminal Half-life (t1/2) of VVD-130850
Dose Escalation and Expansion: Area Under the Plasma Concentration-time Curve (AUC) of VVD-130850
Dose Escalation and Expansion: Maximum Plasma Concentration (Cmax) of VVD-130850
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Expansion: VVD-130850 Single AgentExperimental Treatment1 Intervention
Participants will receive VVD-130850 at recommended dose for expansion (RDE), orally, once daily in 21-day treatment cycles during the dose expansion phase.
Group II: Dose Expansion: VVD-130850 + Pembrolizumab Combination TherapyExperimental Treatment2 Interventions
Participants will receive VVD-130850 at RDE orally, once daily along with pembrolizumab IV infusion, Q3W in 21-day treatment cycles during the dose expansion phase.
Group III: Dose Escalation: VVD-130850 Single AgentExperimental Treatment1 Intervention
Participants will receive ascending doses of VVD-130850, orally, once daily in 21-day treatment cycles during the dose escalation phase.
Group IV: Dose Escalation: VVD-130850 + Pembrolizumab Combination TherapyExperimental Treatment2 Interventions
Participants will receive ascending doses of VVD-130850, orally, once daily, along with pembrolizumab intravenous (IV) infusion, every 3 weeks (Q3W) in 21-day treatment cycles during the dose escalation phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Vividion Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different venues can this clinical trial be accessed?

"To facilitate the enrollment of patients in this trial, four sites are actively recruiting participants. These include NEXT Austin located in Austin, NEXT Dallas situated in Irving, and NEXT Virginia based in Fairfax. Additionally, there are four other locations available for patient recruitment."

Answered by AI

What is the current number of individuals being recruited for participation in this research study?

"Indeed, according to the information available on clinicaltrials.gov, this study is currently actively seeking participants. The initial posting of the study was made on January 1st, 2024 and its most recent update occurred on December 31st, 2023. A total of 160 individuals will be enrolled in this trial across four distinct locations."

Answered by AI

Are individuals still being enrolled for participation in this clinical trial?

"Indeed, the data available on clinicaltrials.gov confirms that this clinical trial is actively seeking eligible participants. The original posting date of the study was January 1st, 2024, with the most recent update made on December 31st, 2023. To reach their goal, the trial aims to enroll a total of 160 patients distributed across four distinct locations."

Answered by AI

Has the combination treatment of VVD-130850 and pembrolizumab received official endorsement from the FDA for dose expansion?

"Due to the nature of this being a Phase 1 trial, with limited available data on safety and efficacy, our team at Power rates the safety of Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy as a 1."

Answered by AI

Who else is applying?

What site did they apply to?
NEXT Dallas
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Saving up to buy a house.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors
2024. "A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06188208.
All > Pflugerville Tx > Paid Studies Austin
~107 spots leftby Dec 2027
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