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

Sponsor

Vividion Therapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05954312

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: VVD-130037	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VVD-130037 Dose Escalation Participants will receive ascending doses of VVD-130037, orally, once daily in 21-day treatment cycles.	Drug: VVD-130037 Oral tablets

Arm

Intervention/Treatment

Experimental: VVD-130037 Dose Escalation

Participants will receive ascending doses of VVD-130037, orally, once daily in 21-day treatment cycles.

Drug: VVD-130037

Oral tablets

Outcome Measures

Primary Outcome Measures

Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period [From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]]
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.

Secondary Outcome Measures

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)]
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)]
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)]
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)]
QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters [Up to end of treatment (up to approximately 4 years)]
Number of participants with changes in QT/QTc interval and other ECG parameters will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

KEAP1 nonsense mutation (any position)
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:

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.