Custom-Made antibodies could turn the Body's own defenses against cancer
NCT ID NCT07783620
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether antibodies created in a lab from a patient's own tumor can help the immune system attack and kill cancer cells. The antibodies are designed to target specific markers on cancer cells that are not found on healthy cells. Participants with stage IV cancer who have not responded to standard treatments will receive infusions of these personalized antibodies. The main goal is to assess safety and see if this approach can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- patient-specific chimeric antibodies made from each subject's tumor cells
- What this could lead to
- If successful, this approach could lead to a personalized treatment that harnesses the immune system to fight advanced cancer, potentially offering a path to remission for patients who have run out of options.
- What could go wrong
- This is an early-phase trial with only 16 participants, so safety and effectiveness are not yet established. The antibodies are custom-made for each person, which is complex and may not work for everyone, and there is a risk of severe side effects.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Dec 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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 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: ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported) Platelets ≥ 100,000/µl (can be transfused) Hemoglobin \> 8 g/dL (can be transfused) 7. Renal: Serum creatinine ≤ 1.5 x upper limit of institutional normal. Adequate liver function must be demonstrated, defined as: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) ALT (SGPT) ≤ 3 times upper limit of normal (ULN) 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Soft tissue cancer are added.
By submitting, you agree to our Terms of use
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.
-
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.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.