Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)

NCT07179783 | Recruiting Phase 2

• 1 other identifier: SKB264-KL-A167-AVPC/NEPC-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and Tagitanlimab (KL-A167) in the treatment of AVPC (aggressive variant prostate cancer) and NEPC (neuroendocrine prostate cancer).

Conditions

Prostate Cancer (Adenocarcinoma); Prostate Cancer Metastatic Castration-Resistant; Prostate Adenocarcinoma With Neuroendocrine Differentiation

Keywords

NEPC; AVPC; TROP2; PD-L1

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1)/ Prostate Cancer Clinical Trials Working Group(PCWG3).

  Up to approximately 24 months

Secondary Outcomes (5)

• Progression Free Survival(PFS)

  From treatment administration up to a maximum duration of 24 months.

• Duration of Response(DOR)

  Through study completion, an expected average of 24 months.

• Disease Control Rate (DCR)

  From treatment administration up to a maximum duration of 24 months.

• Overall Survival(OS)

  From treatment administration up to a maximum duration of 24 months.

• Percentage of Participants With Adverse Events (AEs)

  Up to approximately 24 months.

Other Outcomes (1)

• Exploring predictive effectiveness indicator

  Up to approximately 24 months.

Study Arms (1)

SKB264-KL-A167 Treatment Group

EXPERIMENTAL

This treatment group will receive a combination therapy of SKB264 and KL-A167.

Drug: Sacituzumab Tirumotecan; Drug: Tagitanlimab

Interventions

Sacituzumab Tirumotecan DRUG

Drug reduction will be implemented according to the research plan.

Also known as: SKB264, Sac-TMT, MK-2870

SKB264-KL-A167 Treatment Group

Tagitanlimab DRUG

Treatment with Sacituzumab Tirumotecan (SKB264, 5mg/kg IV d1 Q2W) and Tagitanlimab (KL-A167 , 900mg IV d1 Q2W) until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terminate treatment, or other treatment termination criteria specified in the protocol (based on the first patient), with a maximum treatment duration of 24 months for Tagitanlimab. Drug reduction will be implemented according to the research plan.

Also known as: KL-A167

SKB264-KL-A167 Treatment Group

Eligibility Criteria

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

You may qualify if:

• Age at the time of signing the informed consent form is ≥ 18 years old;
• AVPC or NEPC diagnosed based on recent histological and/or clinical criteria;
• Having received one or two second-generation anti androgen therapies in the past, previous use of docetaxel for castration resistant prostate cancer (CRPC) is allowed, and the use of other chemotherapy is not allowed;
• The progression of prostate cancer in the subjects within 6 months prior to screening shall be determined by the researcher through one of the following methods:
• PSA is evaluated by local laboratories, and PSA progression is defined as at least two increases in PSA levels at intervals of ≥ 1 week, with a screening PSA value of ≥ 2 ng/ml.
• Soft tissue imaging disease progression determined based on PCWG modified RECIST 1.1 or RECIST 1.1 criteria, regardless of PSA progression.
• The imaging disease progression of bones is defined as the appearance of two or more new bone lesions in bone scans, regardless of PSA progression.
• Subjects who have not undergone past surgery must be using and voluntarily continue to use luteinizing hormone releasing hormone (LHRH) agonists throughout the entire study treatment period;
• Within 7 days prior to administration, the physical fitness status score of the Eastern Cooperative Oncology Group (ECOG) in the United States was 0 or 1;
• Expected survival period ≥ 12 weeks;
• Having sufficient organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to administration), defined as follows:
• Blood routine: neutrophil count (NEUT #) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 100 × 109/L; hemoglobin ≥ 90 g/L;
• Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; For subjects with liver metastasis at baseline, ALT and AST should be ≤ 5 × ULN; Albumin ≥ 30g/L; Total bilirubin (TBIL) ≤ 1.5 × ULN;
• Renal function: creatinine clearance rate ≥ 50 ml/min (calculated using the standard Cockcroft Gault formula);
• Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤ 1.5 × ULN;

You may not qualify if:

• Previously received any of the following treatments (including in the context of adjuvant or neoadjuvant therapy):
• Targeted treatment of TROP2;
• Any drug therapy containing targeted topoisomerase I, including antibody conjugated drug (ADC) therapy;
• Immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any other treatment targeting the tumor immune mechanism;
• Those who require the use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first administration and during the study period (strong inhibitors or inducers of CYP3A4 are not allowed in this study, and representative drugs of CYP3A4 strong inhibitors or inducers are listed in Appendix 7); All subjects must avoid the concurrent use of any drugs, herbal supplements, and/or intake of such foods known to induce CYP3A4 as much as possible;
• Subjects with central nervous system (CNS) metastases known to have meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or untreated conditions. For subjects with brain metastases who have received local treatment in the past, if they have been clinically stable for at least 4 weeks before medication and have not required the use of glucocorticoids or anticonvulsants for at least 14 days, they are allowed to be enrolled;
• Suffering from other malignant tumors within 3 years before administration (excluding tumors that have been cured through local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.);
• There are any of the following cardiovascular diseases or cardiovascular risk factors:
• Within 6 months prior to administration, if there is a myocardial infarction, unstable angina, acute or persistent myocardial ischemia, grade 3 or 4 heart failure (according to the New York Heart Association (NYHA) classification), symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular and cerebrovascular diseases;
• Previous history of myocardial diseases such as myocarditis, primary cardiomyopathy, and specific cardiomyopathy;
• Any deep vein thrombosis (if stabilized for ≥ 2 weeks with low molecular weight heparin or similar efficacy drugs), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events within 3 months prior to administration;
• Major vascular diseases that may endanger life or require surgery within 6 months prior to administration, such as aortic aneurysm, aortic dissection aneurysm, etc;
• According to researchers' assessment, uncontrolled systemic diseases:
• Poor control of diabetes (fasting blood glucose ≥ 10 mmol/L for two consecutive times);
• Poor control of hypertension (systolic blood pressure\>160 mmHg and/or diastolic blood pressure\>100 mmHg);

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead
• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

18-O-demethylcervinomycin A2

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Haitao Wang, Ph.D

  Tianjin Medical University Second Hospital

  STUDY CHAIR

Central Study Contacts

Haitao Wang, Ph.D

CONTACT

+86-022-88326610; peterrock2000@126.com

Jinhuan Wang, Ph.D

CONTACT

+86-022-88326385; wjhhappy2008@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 18, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)