Is NCT05901285 recruiting in Washington Dc, DC?

Yes, NCT05901285 is currently recruiting participants at its Washington Dc, DC location. This advanced solid tumor clinical trial is actively enrolling qualified participants.

How do I join the advanced solid tumor clinical trial in Washington Dc?

To join this clinical trial in Washington Dc, 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 Washington Dc 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 Tumor Clinical Trial in Washington Dc, DC

About This Advanced Solid Tumor Study in Washington Dc

The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for intratumoral injections (VAX014) as a single agent as well as in combination with Investigator's choice of nivolumab or pembrolizumab in patients with advanced solid tumors. VAX014 is a targeted oncolytic agent designed to kill tumor cells following intratumoral injection into advanced solid tumors.

Sponsor: Vaxiion Therapeutics

Who Can Participate

Inclusion Criteria

Informed consent

Histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor

Progression following at least one prior standard treatment or intolerant of standard treatments.

\[Dose Escalation\] Availability of archival or fresh tumor tissue

\[Expansion\] Willing to undergo biopsy of the tumor to be injected prior to the initial VAX014 injection (may provide archival tissue instead if approved by Medical Monitor)

No available SOC therapy that would confer clinical benefit

\[Dose escalation\] At least one cutaneous, subcutaneous, or nodal injectable tumor (between 1 and 10 cm in largest diameter) that can be injected by direct palpation or with the assistance of ultrasound without the need for interventional radiology

\[Expansion\] At least one injectable tumor (\>=0.5cm in largest diameter) that can be injected either with or without the need for interventional radiology

\[Expansion\] Appropriate for treatment with either nivolumab or pembrolizumab

\[Expansion\] Progression following at least one prior regimen containing PD-1 directed immune checkpoint blockade

Measurable disease by RECIST v1.1

ECOG Performance Status of 0, 1, or 2

Resolution of any toxicity associated with prior therapy to ≤ Grade 1 (Residual toxicity of Grade 2 may be allowed following discussion with Medical Monitor)

Adequate hematologic function defined as:

Absolute neutrophil count \>=1,500/uL

Platelet count \>=100,000/uL

\[Expansion\] Hemoglobin \>=9 gm/dL

Adequate hepatic function defined as:

Total bilirubin ≤ 1.5 x ULN

Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN

Adequate coagulation defined as:

International normalized ratio (INR) ≤ 1.5 x ULN or prothrombin time (PT) ≤ 1.5 x ULN

Partial thromboplastin time (PTT) or activated PTT (aPTT) ≤ 1.5 x ULN

Serum creatinine ≤ 1.5 x ULN or estimated GFR ≥ 60 mL/min/1.73 m2 (per MDRD GFR formula)

Women of childbearing potential must have a negative serum pregnancy test

All subjects of childbearing potential must be willing to consent to using effective contraception (as determined by the Investigator) while on treatment and for 3 months after their participation in the study ends

Exclusion Criteria

Injectable tumor not sufficiently distanced from critical structures (e.g., major airway, neurovascular structure) where post injection swelling may place the subject at unacceptable risk

≤ 21 days or ≤ five half-lives (whichever is shorter) between any prior anticancer therapy (e.g., chemotherapy, immunotherapy, intralesional therapy, irradiation) and the first injection of VAX014

Known CNS metastases or leptomeningeal carcinomatosis, unless adequately treated and clinically stable off steroids for ≥ 14 days from the first injection of VAX014

Severe infection requiring systemic antibiotic therapy or hospitalization for treatment of injection

Need for systemic immunosuppressive therapy (≤10 mg of prednisone equivalent, or one time pulse steroids excepted)

Active autoimmune disease requiring systemic immunosuppressive therapy

Active lung disease or pneumonitis

History of Grade 4 toxicity in response to prior PD-1 blockade

Any other malignancy likely to require treatment in the next 2 years (exceptions include cancer such as basal or squamous cell skin cancers, noninvasive cancer of the cervix, and local prostate cancer)

Known active infection with tuberculosis or HIV

Active Hepatitis B or C

\[Females\] pregnant or breastfeeding

Clinically significant cardiovascular abnormalities including:

≤ 12 months from prior MI

Unstable angina pectoris

≤ 6 months from NYHA classification \>=3 CHF

Electrocardiogram (ECG) with QTcF \> 450 msec (males) and QTcF \> 470 msec (females) based on an average of triplicate ECGs (triplicate ECGs performed only if initial QTcF exceeds male/female limits)

Medical or psychological condition that places the subject at undue risk with study participation

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 Washington Dc?

Yes, this clinical trial (NCT05901285) has an active research site in Washington Dc, DC 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 Tumor Treatment Options in Washington Dc, DC

If you're searching for advanced solid tumor treatment options in Washington Dc, DC, this clinical trial (NCT05901285) 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 Washington Dc research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced solid tumor 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 tumor clinical trials near you to find additional studies recruiting in your area.

Advanced Solid Tumor Clinical Trial in Washington Dc, DC

Expert Care in Washington Dc

IRB Approved

No-Cost Care

Apply for This Washington Dc Location

Why Participate?

Simple Process