OncoMatch/Clinical Trials/NCT07179783

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

Is NCT07179783 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sacituzumab Tirumotecan and Tagitanlimab for prostate cancer (adenocarcinoma).

Phase 2RecruitingTianjin Medical University Second HospitalNCT07179783Data as of May 2026

Treatment: Sacituzumab Tirumotecan · Tagitanlimab — 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).

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Neuroendocrine Tumor

Disease stage

Metastatic disease required

Prostate Cancer Metastatic Castration-Resistant

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines

Min 1 prior line

Must have received: second-generation antiandrogen

Having received one or two second-generation anti androgen therapies in the past

Cannot have received: TROP2-targeted therapy

Targeted treatment of TROP2

Cannot have received: topoisomerase I inhibitor

Any drug therapy containing targeted topoisomerase I, including antibody conjugated drug (ADC) therapy

Cannot have received: immune checkpoint inhibitor

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

Lab requirements

Blood counts

neutrophil count (neut #) ≥ 1.5 × 109/l; platelet count (plt) ≥ 100 × 109/l; hemoglobin ≥ 90 g/l

Kidney function

creatinine clearance rate ≥ 50 ml/min (calculated using the standard cockcroft gault formula)

Liver function

ast and 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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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