A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of VVD-130037, a Kelch-like ECH Associated Protein 1 (KEAP1) Activator, in Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954312
• Other study ID #: VVD-130037-001
• Status: Recruiting
• Phase: Phase 1
• Start date: July 28, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Vividion Therapeutics, Inc.
• Contact: Vividion Clinical Trial Call Center
• Phone: (858) 345-9752
• Email: clinicaltrials[@]vividion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A FIH study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VVD-130037 in participants with advanced solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• VVD-130037
Oral tablets

Locations

Country	Name	City	State
Spain	START Barcelona Hospital HM Nou Delfos	Barcelona
Spain	NEXT Madrid	Madrid
Spain	START Madrid CIOCC	Madrid
Spain	Start Madrid-FJD, Hospital Fundacion Jimenez Diaz	Madrid
United States	NEXT Virginia	Fairfax	Virginia
United States	MDACC	Houston	Texas
United States	NEXT Dallas	Irving	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Florida Cancer Specialists	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vividion Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period	Incidence and severity of DLTs will be assessed per DLT criteria set forth in the protocol based on adverse events (AEs) evaluated per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]
Secondary	Number of Participants With AEs, Serious Adverse Events (SAEs), and Clinical Laboratory Abnormalities		From the administration of first dose through 30 days after last study drug administration or start of subsequent therapy (up to approximately 4 years)
Secondary	Area Under the Plasma Concentration-time Curve (AUC) of VVD-130037		Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)
Secondary	Maximum Observed Concentration (Cmax) of VVD-130037		Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)
Secondary	Apparent Terminal Half-life (T1/2) of VVD-130037		Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)
Secondary	QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters	Number of participants with changes in QT/QTc interval and other ECG parameters will be assessed.	Up to end of treatment (up to approximately 4 years)