Scientists create personalized antibodies to attack stage IV cancer
NCT ID NCT06674538
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial tests whether antibodies made from a patient's own tumor can safely target and help destroy cancer cells. Researchers take blood and tumor samples to create custom antibodies that recognize unique markers on the cancer cells. The antibodies are then given through infusions to 12 adults with stage IV cancers that have not responded to prior treatments. The main goal is to check safety, not yet to prove the treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- custom-made chimeric antibodies
- What this could lead to
- If it works, this could point toward a personalized treatment for advanced cancers that have not responded to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 12 people, so it is mainly checking safety, not effectiveness. The antibodies are made individually, which is complex and may not work for everyone.
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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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jan 2029
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects 18 years of age or older who have biopsy proven cancer. The following types of malignancy will be eligible: Stage IV cancer of the following types: breast cancer, colon cancer, esophageal cancer, kidney cancer, lung cancer, lymphoma, melanoma, ovarian cancer, pancreatic cancer, bladder, urothelial carcinoma, head and neck cancers, prostate cancer, sarcomas, and stomach cancer. 2. Subjects who have refractory or progressive disease after at least 1 line of systemic treatment or who have declined additional curative standard of care therapy(ies). 3. Subjects willing to consent to obtaining a blood sample and archived tumor tissue for genomic extraction and amplification. If archived tumor tissue is not available, a new biopsy sample will be required. If sequencing was previously completed under Moonshot Antibodies IRB protocol #20233336 or completed on the patient's tumor as part of clinical care, these results and samples may be used and duplicative tumor sequencing will not be necessary. 4. Subjects must have measurable disease as defined per the Response Evaluation Criteria in Solid Tumor (RECIST) at the time of biopsy. Archived tumor must be available or tumor must be accessible for biopsy. 5. Karnofsky Score must be ≥ 60 6. Hematological: 1. ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported) 2. Platelets ≥ 100,000/µl (can be transfused) 3. Hemoglobin \> 8 g/dL (can be transfused) 7. Renal: Serum creatinine ≤ 1.5 x upper limit of institutional normal. 8. Adequate liver function must be demonstrated, defined as: 1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) 2. ALT (SGPT) ≤ 3 times upper limit of normal (ULN) 3. AST (SGOT) ≤ 3 times upper limit of normal (ULN) 9. A negative serum pregnancy test is required for female participants of childbearing potential (≥13 years of age or after onset of menses) 10. Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-Provera shots). If none of these can be used, contraceptive foam with a condom is recommended. 11. Informed Consent: All subjects must sign written informed consent. Exclusion Criteria: 1. Insufficient tumor tissue for genome sequencing. 2. Known human immunodeficiency virus infection. 3. Subjects who have received any cytotoxic treatment within 3 weeks of antibody treatment. 4. Subjects who have received any radiotherapy to the tumor biopsy sample site within the last 14 days (radiation may be included in treatment decision after biopsy). 5. Subjects who have received live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. 6. Subjects who are currently receiving or have received systemic therapeutic corticosteroids ≤2 weeks prior to starting treatment. 7. Subjects receiving any investigational drug concurrently. 8. Subjects with chronic active autoimmune diseases undergoing treatment. 9. Subjects who have had prior organ transplant. 10. Subjects who have developed allergic responses to chimeric antibodies. 11. Subjects with symptomatic known brain metastases \< 4 weeks from radiation treatment 12. Subjects with significant (\>Grade 2 toxicity) renal, cardiac, pulmonary, hepatic or other organ dysfunction. 13. Subjects with secondary cancers that require systemic treatment. 14. Subjects that are pregnant or breastfeeding. 15. Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor) including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia. 16. Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign the informed consent, and subject's ability to cooperate and participate in the study 17. Adult subjects lacking capacity to consent.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Penn State Cancer Institute
Hershey, Pennsylvania, 17033, United States
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