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Prostate Cancer (Adenocarcinoma)Phase 2NCT07179783

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

A Phase 2 study testing Sacituzumab Tirumotecan and Tagitanlimab in people with Prostate Cancer (Adenocarcinoma) and Prostate Cancer Metastatic Castration-Resistant, run by Tianjin Medical University Second Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Sacituzumab Tirumotecan and Tagitanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
22 Sep 2025to 31 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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;
  • According to RECIST v1.1, there should be at least one measurable lesion, and previously irradiated lesions should not be selected as target lesions; Subjects with only skin or bone lesions are not eligible for inclusion;
  • 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;
  • For subjects whose partners have fertility potential, they must agree to take effective medical contraceptive measures within 6 months from the signing of the informed consent form until the last administration (see Annex 2 for details);
  • The subjects voluntarily joined this study, signed an informed consent form, and were able to comply with the visit and related procedures specified in the protocol.

Who cannot join

  • 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;
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  • 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);
  • Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (>once per week);
  • History of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment, current ILD or non infectious pneumonia, or suspected ILD or non infectious pneumonia that cannot be excluded by imaging examination during screening;
  • Clinical severe lung damage caused by concurrent lung diseases, including but not limited to any underlying lung disease (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc. within 3 months before administration) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (i.e. rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or previous total pneumonectomy;
  • Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding;
  • Individuals with bleeding tendencies such as acute gastrointestinal bleeding, persistent bleeding disorders, or coagulation dysfunction;
  • The toxicity of previous anti-tumor treatments has not yet recovered to ≤ level 1 (evaluated based on NCI CTCAE v5.0) or the levels specified in the inclusion and exclusion criteria (excluding toxicity judged by researchers to be of low safety risk such as hair loss and fatigue).
  • Suffering from active autoimmune diseases that require systemic treatment within the past two years (including but not limited to: autoimmune hepatitis, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.), systemic treatment includes drugs to improve the condition, immunosuppressants, systemic corticosteroid administration (>10 mg/day prednisone or equivalent drugs), etc. Hormone replacement therapy, such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a systemic treatment; Subjects who received systemic corticosteroid treatment with>10 mg/day prednisone or other immunosuppressive drugs within 2 weeks prior to administration.
  • Known active pulmonary tuberculosis. Subjects suspected of having active pulmonary tuberculosis need to undergo clinical examination for exclusion;
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  • Accompanied by ≥ grade 2 peripheral neuropathy;
  • Active hepatitis B [hepatitis B surface antigen (HBsAg) is positive, and HBV-DNA detection is required; HBV-DNA ≥ 500 IU/mL or higher than the lower limit of detection, whichever is higher] or hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection). Note: HBsAg positive subjects are required to receive anti hepatitis B virus treatment during the study treatment;
  • Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection;
  • Known allergies to the investigational drug or any of its components, and a history of severe hypersensitivity reactions to other biological agents;
  • Individuals who have undergone major surgery within 4 weeks prior to administration or are expected to undergo major surgery during the study period;
  • Serious infection occurred within 4 weeks prior to administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; Within 2 weeks prior to administration, there is an active infection that requires systemic anti infective treatment;
  • A recorded history of severe dry eye syndrome, severe meibomian gland disease and/or meibomian inflammation, or corneal diseases that hinder delayed corneal healing;
  • Have received non-specific immunomodulation therapy (including but not limited to interferon and IL-2), traditional Chinese patent medicines and simple preparations preparations with approved anti-tumor indications, etc. within 2 weeks before administration;
  • Received a live vaccine within 30 days prior to administration, or planned to receive a live vaccine during the study period; During the screening process before administration, the condition rapidly deteriorates, such as significant changes in physical fitness status;
  • 25) Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risks and/or uncertainty in survival evaluation, such as tumor like leukemia reactions, cachexia manifestations, etc; 26) Any condition that the researcher deems to interfere with the evaluation of the investigational drug, the safety of the subjects, or the interpretation of the research results, or any other condition that the researcher deems unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haitao Wang, Ph.D contact

+86-022-88326610

peterrock2000@126.com

Jinhuan Wang, Ph.D contact

+86-022-88326385

wjhhappy2008@163.com

China1 site, 1 recruiting

  • Tianjin Medical Unversity Second Hospital

    Tianjin, Tianjin Municipality, 300211

    Haitao Wang, Ph.D, +86-022-88326385, peterrock2000@126.com

    Lili Wang, Ph.D

    Recruiting

Other trials in China

About this study

Official title: Phase II Study of the Combination of Sacituzumab Tirumotecan(SKB264)and Tagitanlimab (KL-A167) in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)

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).

Read the detailed description

More than 60% of newly diagnosed cases of prostate cancer in China are in the middle and late stages, with an overall poor prognosis. Prostate cancer is AVPC (aggressive variant prostate cancer) and NEPC (neuroendocrine prostate cancer), two highly invasive and poorly prognosis non androgen receptor driven subtypes of prostate cancer. The overall prognosis of advanced AVPC and NEPC is poor, with a median OS of only 7-20 months after diagnosis. At present, there is a lack of a unified standard protocol for drug treatment of AVPC and NEPC. The recommended treatment plan in the diagnosis and treatment guidelines is mainly platinum based chemotherapy, as the behavior of AVPC and NEPC is similar to that of small cell lung cancer, and can be treated according to the guidelines for small cell lung cancer.More research is still underway on the use of immunotherapy combined with chemotherapy for advanced AVPC/NEPC. 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 advanced AVPC and NEPC.The above research suggests that immunotherapy combined with chemotherapy has further exploration value in advanced AVPC/NEPC.

Being tested
Sacituzumab Tirumotecan, Tagitanlimab
Keywords
NEPC, AVPC, TROP2, PD-L1
Medical subject headings
Prostatic Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab TirumotecanDrug

    Also called SKB264, Sac-TMT, MK-2870

    Drug reduction will be implemented according to the research plan.

  • TagitanlimabDrug

    Also called KL-A167

    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.

Study groups in NCT07179783
Study groupRoleWhat they receive
SKB264-KL-A167 Treatment GroupExperimentalThis treatment group will receive a combination therapy of SKB264 and KL-A167.
Receives: Drug: Sacituzumab Tirumotecan; Drug: Tagitanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to approximately 24 months

Secondary outcomes (5)

  1. Progression Free Survival(PFS)

    The time from the beginning of the patient's treatment to the disease progression or death for any reason. Based on RECIST criteria v1.1/ PCWG3.

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

  2. Duration of Response(DOR)

    Duration of Response, from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.

    Measured: Through study completion, an expected average of 24 months.

  3. Disease Control Rate (DCR)

    The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects after the last subject participating in.

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

  4. Overall Survival(OS)

    Time from start of treatment to death due to any cause.

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

  5. Percentage of Participants With Adverse Events (AEs)

    Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0.

    Measured: Up to approximately 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2025
  2. Study start22 Sep 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07179783
Sponsor's protocol ID
SKB264-KL-A167-AVPC/NEPC-01
Status last verified
Sep 2025
First submitted
8 Sep 2025
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After the experiment is completed, the data maybe shared after academic publication.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Tirumotecan and Tagitanlimab in people with Prostate Cancer (Adenocarcinoma) and Prostate Cancer Metastatic Castration-Resistant, run by Tianjin Medical University Second Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haitao Wang, Ph.D (+86-022-88326610, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07179783.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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