Custom-Made antibodies could turn the Body's own defenses against cancer

NCT ID NCT07783620

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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  1. The official record

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