New antibody combo aims to control hard-to-treat prostate cancer
NCT ID NCT06866548
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.
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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 7 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Male participants only
- 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. 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
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Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Radioactive missile aims at prostate cancer that spread
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?