Is NCT06004245 recruiting in Louisville, KY?

Yes, NCT06004245 is currently recruiting participants at its Louisville, KY location. This advanced solid tumors clinical trial is actively enrolling qualified participants.

How do I join the advanced solid tumors clinical trial in Louisville?

To join this clinical trial in Louisville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Louisville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Solid Tumors Clinical Trial in Louisville, KY

About This Advanced Solid Tumors Study in Louisville

This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with bevacizumab or pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.

Sponsor: Vividion Therapeutics, Inc.

Who Can Participate

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Have a microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor; For the combination with bevacizumab only: advanced, or metastatic colorectal adenocarcinoma (CRC) treated with at least 2 but no more than 3 prior lines of systemic therapy for the treatment of advanced CRC; For the combination with pembrolizumab only: Histologically confirmed locally advanced, or metastatic CRC with no prior systemic treatment for metastatic disease and not amenable to surgery

Have received and then progressed following, or are intolerant to, standard therapy in the advanced setting

Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Life expectancy of at least (≥)12 weeks

Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing; for participants without archival tissue, a biopsy from either primary or metastatic tumor lesion, deemed medically feasible, must be taken

Adequate hematologic, end-organ, and cardiovascular function, as defined in the protocol

Exclusion Criteria

Inability or unwillingness to swallow pills

Malabsorption syndrome or other condition that would interfere with enteral absorption

Known hypersensitivity or intolerance to ingredients from the study drug formulation including patients with rare genetic disorders such as galactosaemia, glucose-galactose intolerance or congenital lactase deficiency

Known uncontrolled central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis

Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis and atypical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds), or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of the course of antibiotics, except if for tumor fever) or 6 months for any intracranial abscess

Has a positive test at screening for hepatitis B virus, hepatitis C virus, or for human immodeficiency virus (HIV), per local diagnostic standard and in accordance with local laws and regulations

Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined as a screening hemoglobin A1c \<8% and no urinary ketoacidosis)

Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 of study drug administration

Alcohol or drug dependence or abuse

Patients with known Werner (WRN) syndrome

Prior treatment with any WRN helicase inhibitor

Treatment with moderate or strong CYP3A4 inducers within 14 days prior to initiation of study treatment

Treatment with moderate or strong CYP3A4 or P-glycoprotein inhibitors within 14 days prior to initiation of study treatment

Pregnancy, breastfeeding, or intention of becoming pregnant during the study Additional Exclusion Criteria for the Combination with Bevacizumab Only:

Had major surgery within 4 weeks prior to study drug administration

Deep venous thrombosis (DVT) or pulmonary embolism (PE) within 12 weeks prior to study drug administration

Known coagulopathy that increases the risk of bleeding

Patients with Grade 2+ proteinuria (exception: if 24-hour urinary protein is less than 1.0 gm/24 hours) Additional Exclusion Criteria for the Combination with Pembrolizumab Only:

Active or history of autoimmune disease or immune deficiency with some exceptions

History of interstitial lung disease or pneumonitis

Treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment with some exceptions

Treatment with organ transplant/graft tissue

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Louisville?

Yes, this clinical trial (NCT06004245) has an active research site in Louisville, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Solid Tumors Treatment Options in Louisville, KY

If you're searching for advanced solid tumors treatment options in Louisville, KY, this clinical trial (NCT06004245) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Louisville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced solid tumors specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced solid tumors clinical trials near you to find additional studies recruiting in your area.

Advanced Solid Tumors Clinical Trial in Louisville, KY

Expert Care in Louisville

IRB Approved

No-Cost Care

Apply for This Louisville Location

Why Participate?

Simple Process