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

• Status: Recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vividion Therapeutics, Inc.

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.