Microdose cancer drug test could reveal best treatments without side effects
NCT ID NCT04541108
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests very small amounts of cancer drugs injected directly into accessible tumors in 15 adults scheduled for surgery. The goal is to see how the drugs affect the tumor's environment, like killing cancer cells or activating immune cells, without causing full-body side effects. It is a research tool to gather information, not a treatment itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\*This list is representative of study inclusion/exclusion criteria. Each substudy may include variations on these criteria. Inclusion Criteria: 1. Ability and willingness to comply with the study's visit and assessment schedule. 2. Male or female ≥ 18 years of age at Visit 1 (Screening). 3. Pathologic diagnosis of \[solid tumors\] indicated in the relevant substudy(ies). 4. Ability and willingness to provide written informed consent. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 5. At least one lesion (primary tumor, recurrent tumor, or metastatic lymph node) that is surface accessible for CIVO injection that contains viable minimum tumor tissue volume and characteristics (e.g., based on clinical evaluation, available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports indicating lesion with appropriate viable tumor volume without excessive cysts or necrosis) and for which there is a planned surgical intervention. The patient's presentation, surgical and pathology plan may determine whether a lesion is eligible with respect to a given CIVO MID needle configuration. 6. Female patients who: * Are postmenopausal for at least one year before the screening visit, OR * Are surgically sterile, OR * Are of childbearing potential who agree to practice a highly effective method of contraception from the time of signing the Informed Consent Form (ICF) and during study participation OR agree to completely abstain from heterosexual intercourse. * Agree to refrain from donating ova during study participation. Male patients, even if surgically sterile (i.e., status post-vasectomy), who: * Agree to practice effective barrier contraception from the time of signing the ICF and during study participation OR agree to completely abstain from heterosexual intercourse. * Agree to refrain from donating sperm during study participation. Exclusion Criteria: 1. Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient. 2. Female patients who are: * Both lactating and breastfeeding, OR * Have a positive β-subunit human chorionic gonadotropin (β-hCG) pregnancy test at screening verified by the Investigator. 3. Any uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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LSU Health Sciences Center - Shreveport
Shreveport, Louisiana, 71115, United States
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MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
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Montefiore Medical Center
The Bronx, New York, 10467, United States
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Oregon Health & Science University (OHSU)
Portland, Oregon, 97239, United States
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Sarah Cannon Research Institute
Charleston, South Carolina, 29406, United States
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UC Health
Cincinnati, Ohio, 45229, United States
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University of North Carolina
Chapel Hill, North Carolina, 27599, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
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University of Washington
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Mining Responders' tumors for clues to a universal cancer therapy
- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue
- New antibody aims to preserve immune checkpoint while fighting cancer
- Engineered immune cells target two markers on Hard-to-Treat tumors