Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies (NCT04282044)
🩺 Plain-English Summary (8th-Grade Level)
This clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of CRX100. Patients with non-small cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, hepatocellular carcinoma (HCC), malignant melanoma (excluding uveal melanoma), gastric cancer, triple negative breast cancer, and osteosarcoma. The study will start with monotherapy dose escalation followed by combination cohorts.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (13 items).
Location: HonorHealth Research Institute — Scottsdale, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:
- Subjects with new or progressive brain metastasis. Subjects with treated brain metastases are eligible if there is no evidence of progression for at least four weeks after central nervous system-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
- Subjects who received any chemotherapy or immunotherapies (non-cell-based therapies) or oncolytic virus therapy, radiotherapy, radiosurgery or investigational agents within three weeks of enrollment.
- Subjects who still are experiencing Grade 2 or higher AEs from prior therapies such as surgery, radiation therapy and systemic anti-cancer therapies unless approved by sponsor.
- Subjects who received any type of cell-based therapies within the last 12 weeks from the planned apheresis date.
- Subjects experiencing any active infections (bacterial, viral, or fungal) for which systemic antimicrobials are required. Subjects who need prophylactic anti-viral agents that can inhibit the replication of VACV will be excluded from participating.
- Subjects must not have history of active or symptomatic autoimmune disease or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, other symptomatic autoimmune disease, documented history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e., with use of disease modifying agents, steroids or immunosuppressive agents) Exceptions are permitted for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, conditions not expected to recur in the absence of an external trigger or other conditions approved by the medical monitor.
- Have a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to apheresis, and within 14 days prior to infusion. Inhaled, intramuscular injection, or topical steroids and adrenal replacement doses (≤10 mg daily prednisone equivalents) are permitted. Stable doses of steroids are permitted for subjects with pre-treated brain metastases. Short-term (\<48 hr) steroid pretreatment for contrast allergy for imaging is permitted.
- Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illnesses unrelated to cancer, or any serious medical or psychiatric illness that could, in the Investigator's opinion, interfere with participation in this study.
- Pregnant or nursing an infant (subject or household contacts).
- Clinically significant immunodeficiency (e.g., due to underlying illness and/or medication) in a subject or household contacts.
- Have any underlying medical condition (including, but not limited to, ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia), psychiatric condition that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- HonorHealth Research Institute — Scottsdale, Arizona
- UC San Diego Moores Cancer Center — La Jolla, California
- Stanford University — Stanford, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.