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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/1/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kaushal Parikh, M.B.B.S.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Yanyan Lou, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20576947

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