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Trial Title:
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
NCT ID:
NCT05954312
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
VVD-130037
First-in-Human
KEAP1
NRF2
Cancer
small molecule
squamous cell histology
esophageal adenocarcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VVD-130037
Description:
Oral tablets
Arm group label:
VVD-130037 Dose Escalation
Summary:
A FIH study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary
efficacy of VVD-130037 in participants with advanced solid tumors.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Histologically or cytologically confirmed metastatic or unresectable solid tumor.
- Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
(RECIST v1.1) as assessed by the Investigator.
- Have progressed on or after all prior standard-of-care therapies for metastatic
disease.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Adequate organ and marrow function as defined in the protocol.
Key Exclusion Criteria:
- Participant is known to have a mutation that has no expectation of benefit from
VVD-130037. Current such mutations include the following:
1. KEAP1 nonsense mutation (any position)
2. KEAP1 frameshift mutation (any position)
- Any unresolved toxicity Grade ≥2 per CTCAE version 5.0 from previous anticancer
treatment.
- Current or prior treatment with anti-epileptic medications for the treatment or
prophylaxis of seizures.
- History of seizure or condition that may predispose to seizure.
- History or presence of central nervous system (CNS) metastases or spinal cord
compression.
- Uncontrolled arterial hypertension despite optimal medical management.
- Risk factors for abnormal heart rhythm/QT prolongation as defined in the protocol.
- History of the following cardiac diseases:
i) congestive heart failure (New York Heart Association [NYHA] Class >II), ii)
unstable angina, iii) new onset angina within past 6 months, iv) myocardial
Infarction within the past 6 months, v) clinically significant arrhythmias within
past 6 months.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
MDACC
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Dallas
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
START Barcelona Hospital HM Nou Delfos
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Facility:
Name:
NEXT Madrid
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
START Madrid CIOCC
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Start Madrid-FJD, Hospital Fundacion Jimenez Diaz
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Start date:
July 28, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Vividion Therapeutics, Inc.
Agency class:
Industry
Source:
Vividion Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05954312
