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

NCT06866548 | Active Not Recruiting Early Phase 1

• 1 other identifier: HELIX-25
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

mCRPC

Keywords

Prostate Cancer; Metastasis; PD-1; IGF-1R

Outcome Measures

Primary Outcomes (1)

• Safety and adverse event incidence rate

  Incidence rate of adverse events graded according to the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) version 5.0.

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

Secondary Outcomes (11)

• 3-month PSA progression-free survival (PSA-PFS)

  3 months after first infusion

• 6-month imaging progression-free survival (rPFS):

  6 months after first infusion

• 6-month PSA progression-free survival (PSA-PFS)

  6 months after first infusion

• PSA Response Rate

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

• Disease Control Rate

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

Study Arms (1)

Treatment with anti-IGF-1R mAb(Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)

EXPERIMENTAL

Drug: anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)

Interventions

anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab) DRUG

Drug: Teprotumumab/IBI311 Given by IV infusion Initiate dosing with 10 mg/kg for first infusion, followed by 20 mg/kg every 3 weeks. Drug: Tislelizumab Given by IV infusion 200 mg every 3 weeks

Treatment with anti-IGF-1R mAb(Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Substantially normal bone marrow, liver and kidney function:
• white blood cell (WBC) \> 3 x 10\^9 cells/L
• Absolute neutrophil count (ANC) \> 1×10\^9 cells/L
• Hemoglobin \>9.0 g/dL
• Platelet count \>100×10\^9/L
• Serum creatinine \<1.5 × upper limit of normal (ULN)
• Serum total bilirubin \<1.5 × ULN

You may not qualify if:

• 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);
• Subjects with severe cardiovascular disease;
• New York Heart Association (NYHA) Stage III or IV congestive heart failure;
• episode of myocardial infarction or coronary artery bypass grafting (CABG) ≤ 6 months prior to enrollment;
• clinically significant ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or not due to dehydration;
• history of severe non-ischemic cardiomyopathy;
• 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;
• Organ function is in the following abnormalities:
• serum aspartate aminotransferase or alanine aminotransferase \> 2.5\*ULN; CK \> \*ULN; CK-MB \> \*ULN; TnT \> 1.5\*ULN;
• Total bilirubin \> 1.5\*ULN;
• partial thromboplastin time or activated partial thromboplastin time or international normalized ratio \> 1.5\*ULN in the absence of anticoagulant therapy;
• Patients who have planned or may plan to undergo extracorporeal radiation therapy or surgery for prostate cancer during the study period;
• Prior anti-IGF-1R monotherapy and any immune checkpoint inhibitor therapy;

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis; Insulin-Like Growth Factor I, Resistance To

Interventions

teprotumumab; tislelizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shancheng Ren, MD,PhD

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Urology

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 10, 2025
• Study Start: March 10, 2025
• Primary Completion: November 11, 2025
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 1 year after the publication of results
• Access Criteria: Information regarding submitting proposals and accessing data maybe requested from the principal investigator by e-mail.

Locations

CN (1)