Active — Not RecruitingEarly Phase 1

Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

China7 participantsStarted 2025-03-10

Plain-language summary

This trial is designed to evaluate the safety and efficacy of anti-IGF-1R mAb in combination with anti-PD-1 mAb in patients with mCRPC.

Age range18 Years – 85 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men over 18 years old and under 85 years old;
✓. Diagnosed with prostate adenocarcinoma by prostate biopsy pathology report;
✓. Patients with metastatic castration-resistant prostate adenocarcinoma (mCRPC);
✓. evidence of metastatic bone lesions on imaging such as PSMA-PET-CT or bone metastasis imaging ECT;
✓. Serum testosterone in the depot range (\< 50 ng/dL or 1.75 nmol/L);
✓. Patients need to be willing to undergo pre- and on-treatment biopsy;
✓. ECOG score ≤ 2;
✓. Expected survival time of 6 months or more;

✕. Histologically predominantly other types of prostate cancer, such as sarcomas, lymphomas, small cell tumors, and neuroendocrine tumors;
✕. 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;
✕. 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);
✕

Safety and adverse event incidence rate

Timeframe: Through primary completion of study which may take up to 6 months.

NCT IDNCT06866548

SponsorShanghai Changzheng Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-11

Who can participate

Age range18 Years – 85 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men over 18 years old and under 85 years old;
✓. Diagnosed with prostate adenocarcinoma by prostate biopsy pathology report;
✓. Patients with metastatic castration-resistant prostate adenocarcinoma (mCRPC);
✓. evidence of metastatic bone lesions on imaging such as PSMA-PET-CT or bone metastasis imaging ECT;
✓. Serum testosterone in the depot range (\< 50 ng/dL or 1.75 nmol/L);
✓. Patients need to be willing to undergo pre- and on-treatment biopsy;
✓. ECOG score ≤ 2;
✓. Expected survival time of 6 months or more;

✕. Histologically predominantly other types of prostate cancer, such as sarcomas, lymphomas, small cell tumors, and neuroendocrine tumors;
✕. 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;
✕. 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);
✕