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New treatment option for Solid Tumor, Adult
Official title Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT04282044
What this study is testing
What is CRX100 suspension for infusion?
CRX100 suspension for infusion is an investigational medicine, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet all the following criteria to be enrolled in this study:
- Age ≥18 years at the time of consent.
- Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures. (Screening...
- people must have histologically confirmed diagnosis of one of the following tumors: triple negative adenocarcinoma of the breast (human epidermal...
- people must have relapsed disease or refractory disease. people must have received, completed, or become intolerant of prior standard of care...
You likely can't join if
- people who meet any of the following criteria will be excluded from participation in this study:
- people with new or progressive brain metastasis. people with treated brain metastases are eligible if there is no evidence of progression for at...
- people who received any chemotherapy or immunotherapies (non-cell-based therapies) or oncolytic virus therapy, radiotherapy, radiosurgery or...
- people who still are experiencing Grade 2 or higher AEs from prior therapies such as surgery, radiation therapy and systemic anti-cancer therapies...
- people who received any type of cell-based therapies within the last 12 weeks from the planned apheresis date.
- people experiencing any active infections (bacterial, viral, or fungal) for which systemic antimicrobials are required. people who need prophylactic...
See the full eligibility criteria
Who can join
- people must meet all the following criteria to be enrolled in this study:
- Age ≥18 years at the time of consent.
- Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures. (Screening assessments performed prior to informed consent but within the 28-day...
- people must have histologically confirmed diagnosis of one of the following tumors: triple negative adenocarcinoma of the breast (human epidermal growth factor receptor 2 negative, estrogen receptor negative and...
- people must have relapsed disease or refractory disease. people must have received, completed, or become intolerant of prior standard of care therapies or are not expected to derive any clinical benefit from standard of...
- people with Ovarian cancer must have received at least one prior standard of care for their relapsed or refractory disease, which must include a platinum-based regimen.
- people agree to provide fresh tumor tissue that has not been previously irradiated. If biopsy procedure is not safe to perform, then archival tumor tissue (20 slides or a tissue block) can be submitted.
- people must have iRECIST evaluable disease using computed tomography (CT) or magnetic resonance imaging (MRI) with IV contrast, with at least one measurable target lesion.
- people must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- people are expected to have a life expectancy of at least 12 weeks from the time of enrollment.
- Adequate hematologic function at the time of screening, defined as: absolute lymphocyte count (ALC) \>500 cells/mm3, absolute neutrophil count (ANC) \>750 cells/mm3, hemoglobin \>8 g/dL, and platelet count \>50,000...
- Adequate organ function, defined as:
- Renal function: serum creatinine \ 50 mL/min.
- Adequate hepatic function: total bilirubin ≤1.5x institutional ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x institutional ULN, unless liver metastases are present, in which case it must...
- Women of childbearing potential (defined as all people physiologically capable of becoming pregnant) must have negative serum ß-human chorionic gonadotropin (hCG) or urine pregnancy test.
- Women of childbearing potential must agree to use highly effective methods of contraception throughout the study and for six months after the last dose of CRX100.
- Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method throughout the study and for six months after the last dose of CRX100.
- people must be willing and able to comply with all study procedures, requirements, and follow-up examinations.
What rules you out
- people who meet any of the following criteria will be excluded from participation in this study:
- people with new or progressive brain metastasis. people 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...
- people who received any chemotherapy or immunotherapies (non-cell-based therapies) or oncolytic virus therapy, radiotherapy, radiosurgery or investigational agents within three weeks of enrollment.
- people 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.
- people who received any type of cell-based therapies within the last 12 weeks from the planned apheresis date.
- people experiencing any active infections (bacterial, viral, or fungal) for which systemic antimicrobials are required. people who need prophylactic anti-viral agents that can inhibit the replication of VACV will be...
- people 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...
- 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...
- 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...
- 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...
- Have a history of another invasive malignancy, except for the following circumstance: individuals with a history of invasive malignancy are eligible if they have been disease free and off treatment for at least two...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- La Jolla, California, United States
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; La Jolla, California, United States; Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.