Actively Recruiting
Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)
Led by Tianjin Medical University Second Hospital · Updated on 2025-09-18
28
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Second Hospital
Lead Sponsor
S
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Diagnosed with aggressive variant prostate cancer (AVPC) or neuroendocrine prostate cancer (NEPC) based on recent histological or clinical criteria
- Have received one or two second-generation antiandrogen therapies; prior use of docetaxel for castration-resistant prostate cancer allowed; no other chemotherapy allowed
- Evidence of prostate cancer progression within 6 months before screening based on PSA increase or imaging
- If no prior surgery, currently using and willing to continue luteinizing hormone releasing hormone (LHRH) agonists during the study
- At least one measurable lesion per RECIST v1.1, excluding previously irradiated lesions; subjects with only skin or bone lesions are not eligible
- Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0 or 1 within 7 days before administration
- Expected survival of at least 12 weeks
- Sufficient organ and bone marrow function without recent blood transfusions or stimulating therapies
- Agree to use effective contraception if partner has fertility potential during study and 6 months after
- Voluntarily consent to participate and able to comply with study visits and procedures
You will not qualify if you...
- Prior treatment with targeted TROP2 therapy, topoisomerase I targeted drugs, immune checkpoint inhibitors or agonists, immune cell therapy, or other immunotherapy targeting tumor immune mechanisms
- Use of strong CYP3A4 enzyme inhibitors or inducers within 2 weeks before and during the study
- Known central nervous system metastases with active or untreated conditions, except stable treated brain metastases
- Other malignant tumors within 3 years except certain cured skin or cervical cancers
- Serious cardiovascular diseases or events within 6 months before administration
- Uncontrolled systemic diseases including poorly controlled diabetes or hypertension, significant pleural, pericardial effusions or ascites
- History or current interstitial lung disease or pneumonia requiring steroids
- Severe lung damage from other lung diseases or autoimmune diseases affecting lungs
- Active chronic inflammatory bowel disease or severe gastrointestinal conditions
- Bleeding disorders or coagulopathy
- Unresolved toxicity from prior anti-tumor treatments above grade 1
- Active autoimmune diseases requiring systemic treatment in past 2 years or recent systemic corticosteroids
- Active hepatitis B or C infection requiring treatment
- HIV positive or history of AIDS; active syphilis infection
- Allergies to investigational drugs or severe hypersensitivity to biological agents
- Major surgery within 4 weeks before administration or planned during study
- Serious infection within 4 weeks before administration or active infection needing systemic treatment within 2 weeks
- Severe eye diseases affecting healing
- Recent non-specific immunomodulation therapy or traditional Chinese medicines with anti-tumor effects
- Live vaccine within 30 days before or planned during study
- Rapid clinical deterioration during screening
- Non-malignant diseases or tumor-related symptoms increasing medical risks or survival uncertainty
- Any other conditions deemed unsuitable by the researcher for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
Research Team
H
Haitao Wang, Ph.D
CONTACT
J
Jinhuan Wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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