NCT07798778 Clinical Evaluation of SRT-017 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 18 participants in total. It began in 2026-07-30 with a primary completion date of 2027-12-31.

Brief Summary

This is a single-arm, open-label study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of SRT-017 radioligand therapy in patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). All eligible participants will receive SRT-017 intravenous treatment. The primary objectives are to assess safety and tolerability. Secondary objectives include radiation dosimetry, pharmacokinetics, and preliminary antitumor activity.

Eligibility Criteria

Inclusion Criteria: * Male participants aged 18 years or older. * Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant prostate cancer (mCRPC). mCRPC is defined as disease progression under continuous androgen-deprivation therapy (ADT) or after prior bilateral orchiectomy, with serum testosterone maintained at castrate level (\<50 ng/dL or \<1.7 nmol/L), meeting at least one of the Prostate Cancer Working Group 3 (PCWG3) progression criteria: PSA progression (PSA ≥1 ng/mL, ≥25 % increase compared with PSA nadir with an absolute rise ≥2 ng/mL confirmed by two consecutive measurements at least 1 week apart); or radiographic progression (≥2 new bone metastatic lesions on bone scan, or soft-tissue disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)). * Disease progression after treatment with at least one novel androgen-axis drug (NAAD), including abiraterone, enzalutamide, apalutamide, or darolutamide. * Prior chemotherapy, or participants who are ineligible for chemotherapy or decline chemotherapy. * PSMA-positive lesions confirmed by PSMA-PET/CT imaging; PSMA-positive is defined as tumor lesion uptake higher than liver background uptake. * At least one measurable lesion by RECIST 1.1 criteria OR at least one bone metastasis lesion by PCWG3 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1. * Estimated life expectancy of at least 6 months. * No transfusion of blood products, hematopoietic growth factors, or albumin within 14 days before baseline laboratory tests, and adequate organ function as follows: hematologic: absolute neutrophil count ≥ 1.5 × 10⁹/L, white blood cell count ≥ 3.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL; hepatic: albumin ≥ 30 g/L, total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) / aspartate aminotransferase (AST) ≤ 3 × ULN (without liver metastases) or ALT/AST ≤ 5 × ULN (with liver metastases); renal: serum creatinine ≤ 1.5 × ULN; coagulation: international normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 2 × ULN. * Willing to comply with radiation-protection instructions and scheduled study follow-up procedures. * Able to understand study procedures and voluntarily provide written informed consent, and willing to comply with all study-related assessments and follow-up requirements. Exclusion Criteria: * Participants unable to tolerate required imaging examinations. * Received systemic anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy; endocrine therapy is exempt), investigational medicinal products, or investigational medical devices within 4 weeks prior to first study drug administration. * Received prior radiopharmaceutical therapy (such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, lutetium-177) within 6 months before first dose; or received external-beam radiation therapy (EBRT) within 2 months before first dose. * Persistent Grade 4 myelosuppression from prior anti-cancer therapy within 2 weeks before screening, or Grade 3 myelosuppression with recovery duration longer than 6 weeks. * Plan to receive cytotoxic chemotherapy, anti-tumor immunotherapy, radioligand therapy, or other similar anti-cancer treatments during study participation. * Known brain metastases identified at screening. * History of other malignant neoplasms within the past 5 years (curative-treated localized tumors such as basal-cell or squamous-cell skin cancer are permitted). * Symptomatic or impending spinal cord compression. * Prior external-beam radiation therapy covering more than 25 % of bone-marrow-containing skeletal regions. * Significant uncontrolled cardiovascular disease at screening: QTcF \> 470 ms or known long QT syndrome; myocardial infarction, angina pectoris, or coronary artery bypass graft (CABG) within 6 months before screening and judged unsuitable for study entry by investigator. * Uncontrolled bladder-outlet obstruction, urinary incontinence, claustrophobia, or radiophobia at screening. * Positive screening serology for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody. * Hepatitis B surface antigen (HBsAg) positive with active hepatitis B virus (HBV) replication as assessed by HBV-DNA testing and investigator judgment. * Known hypersensitivity to proteins/peptides, drug excipients, or structurally related compounds. * Documented history of drug or alcohol abuse or chronic substance dependence within 1 year prior to screening. * Unwilling to practice effective contraception during study participation and for 6 months after last study drug administration. * Severe active ongoing infection at the time of first planned study drug administration. * Any other medical condition which, in the investigator's judgment, may compromise participant safety, interfere with study result interpretation, or confer unacceptable participant risk.

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