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New antibody combo aims to control hard-to-treat prostate cancer

NCT ID NCT06866548

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This early-stage trial tests whether combining two antibodies (anti-IGF-1R and anti-PD-1) can safely control metastatic castration-resistant prostate cancer (mCRPC) — a type that has stopped responding to hormone therapy. Seven men with advanced disease will receive the combination and be monitored for side effects and signs of cancer progression. The goal is to slow the cancer, not cure it.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 7 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Nov 2028

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 to 85 years

Sex

Male participants only

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. Men over 18 years old and under 85 years old; 2. Diagnosed with prostate adenocarcinoma by prostate biopsy pathology report; 3. Patients with metastatic castration-resistant prostate adenocarcinoma (mCRPC); 4. evidence of metastatic bone lesions on imaging such as PSMA-PET-CT or bone metastasis imaging ECT; 5. Serum testosterone in the depot range (\< 50 ng/dL or 1.75 nmol/L); 6. Patients need to be willing to undergo pre- and on-treatment biopsy; 7. ECOG score ≤ 2; 8. Expected survival time of 6 months or more; 9. Substantially normal bone marrow, liver and kidney function: 1. white blood cell (WBC) \> 3 x 10\^9 cells/L 2. Absolute neutrophil count (ANC) \> 1×10\^9 cells/L 3. Hemoglobin \>9.0 g/dL 4. Platelet count \>100×10\^9/L 5. Serum creatinine \<1.5 × upper limit of normal (ULN) 6. Serum total bilirubin \<1.5 × ULN 7. Serum glutamine aminotransferase \<3 × ULN 8. Aspartate aminotransferase \<3 × ULN 10. willingness to cooperate and complete study follow-up and related tests. 11. The subject or his/her representative voluntarily participates in the study and signs a written informed consent; and 12. The questionnaire can be completed in Chinese. 13. The patient has been informed of the trial; Exclusion Criteria: 1. Histologically predominantly other types of prostate cancer, such as sarcomas, lymphomas, small cell tumors, and neuroendocrine tumors; 2. Active infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5 o F or 38.1 o C) within 1 week prior to enrollment; 3. have received systemic, ongoing immunosuppressive therapy within 14 days prior to receiving study treatment (except for adrenal replacement steroid doses not exceeding 10 mg prednisone equivalent per day in the absence of active autoimmune disease or short-term steroid therapy (\<5 days) within 7 days prior to initiation of study treatment); 4. Subjects with severe cardiovascular disease; 1. New York Heart Association (NYHA) Stage III or IV congestive heart failure; 2. episode of myocardial infarction or coronary artery bypass grafting (CABG) ≤ 6 months prior to enrollment; 3. clinically significant ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or not due to dehydration; 4. history of severe non-ischemic cardiomyopathy; 5. reduced left ventricular ejection fraction (LVEF \<55%), abnormal septal thickness and atrial size associated with myocardial amyloidosis, as assessed by echocardiography or multigated circuit exploration (MUGA) scan; 5. Organ function is in the following abnormalities: 1. serum aspartate aminotransferase or alanine aminotransferase \> 2.5\*ULN; CK \> \*ULN; CK-MB \> \*ULN; TnT \> 1.5\*ULN; 2. Total bilirubin \> 1.5\*ULN; 3. partial thromboplastin time or activated partial thromboplastin time or international normalized ratio \> 1.5\*ULN in the absence of anticoagulant therapy; 6. Patients who have planned or may plan to undergo extracorporeal radiation therapy or surgery for prostate cancer during the study period; 7. Prior anti-IGF-1R monotherapy and any immune checkpoint inhibitor therapy; 8. Intolerance to anti-IGF-1R monotherapy drugs and immune checkpoint inhibitors; 9. uncontrolled major active infectious disease, cardiovascular disease, pulmonary disease, hematologic disease, or psychiatric disease; 10. In the opinion of the investigator, not suitable for participation in this clinical study;

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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

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.