Is NCT06960395 recruiting in Houston, TX?

Yes, NCT06960395 is currently recruiting participants at its Houston, TX location. This solid tumor malignancies clinical trial is actively enrolling qualified participants.

How do I join the solid tumor malignancies clinical trial in Houston?

To join this clinical trial in Houston, 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 Houston 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.

Solid Tumor Malignancies Clinical Trial in Houston, TX

About This Solid Tumor Malignancies Study in Houston

This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR. The study will be conducted in the following 4 parts: * Part 1: VIR-5525 monotherapy dose escalation * Part 2: VIR-5525 monotherapy dose expansion * Part 3: VIR-5525 plus pembrolizumab dose escalation * Part 4: VIR-5525 plus pembrolizumab dose expansion

Sponsor: Vir Biotechnology, Inc.

Who Can Participate

Inclusion Criteria

I 01. Are ≥ 18 years of age, or at the country's legal age of majority of the legal adult age is \>18 years, at the time of signing the ICF. I 02. Have an ECOG performance status of 0 to 1. I 03. Have a life expectancy of at least 12 weeks. I 04. Have histological, pathological, or cytological confirmation of disease type that is unresectable, locally advanced, or metastatic. I 05. Have measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. I 06. Have diseases under study, lines of therapy, and biomarker status, as follows: Have one of the following: • (Parts 1 and 3): NSCLC (nonsquamous or squamous histology), CRC, HNSCC, or CSCC. Note: Participants with nasopharyngeal tumors are eligible. Note: Participants with upper esophageal or salivary gland tumors are not eligible. OR • Have a solid tumor with EGFR amplification (as previously determined locally with an analytically validated assay in a certified testing laboratory). Have no available standard systemic therapy; or standard therapy is intolerable, not effective, or not accessible; or participant has refused standard therapy.

Exclusion Criteria

E 01. Are a WOCBP with a positive serum or urine pregnancy test within 72 hours prior to treatment. E 02. Have acute or chronic infections, including the following:

Acute or chronic active Epstein-Barr virus (EBV) infection (Exception: asymptomatic EBV-positive participants are still eligible)

Chronic active EBV disease defined as a chronic illness lasting at least 6 months, an increased EBV level in either the tissue or the blood, and lack of evidence of a known underlying immunodeficiency

History of hepatitis B infection (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (HCV) infection (defined as HCV \[HCV RNA; qualitative\] is detected)

History of HIV infection. No HIV testing is required unless mandated by the local health authority.

Active infection requiring systemic therapy within 14 days of Cycle 1 Day 1

Known positive COVID-19 test result at screening (Exception: If follow-up test is negative, participants may be eligible if asymptomatic and upon consultation with medical monitor) E 03. Have a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5525 or pembrolizumab, per the investigator E 04. Have a QT interval corrected by Fridericia's method (QTcF) that is \>480 ms E 05. Have received prior systemic anti-cancer therapy, including investigational agents, within 5 half-lives prior to first dose of study intervention. For drugs with a long t1/2, such as mAbs, or for drugs for which the t1/2 is not known, the last dose should not have been within 28 days prior to first dose of study intervention. Note: If the participant has had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention. E 06. Have received prior radiotherapy within 2 weeks of start of study intervention Note: Participants must have recovered from all radiation-related toxicities to Grade ≤1 or baseline, must not require corticosteroids, and must not have had radiation pneumonitis. Exception: External beam radiotherapy, including palliative external radiation, is allowed. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

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 Houston?

Yes, this clinical trial (NCT06960395) has an active research site in Houston, TX 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.

Solid Tumor Malignancies Treatment Options in Houston, TX

If you're searching for solid tumor malignancies treatment options in Houston, TX, this clinical trial (NCT06960395) 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 Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced solid tumor malignancies 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 solid tumor malignancies clinical trials near you to find additional studies recruiting in your area.

Solid Tumor Malignancies Clinical Trial in Houston, TX

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