BridgeMD
New treatment option for Prostate Cancer (Adenocarcinoma)
Official title Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)
ClinicalTrials.gov ID: NCT07179783
What this study is testing
What is Sacituzumab Tirumotecan?
Sacituzumab Tirumotecan is an investigational medicine, being studied as a potential treatment for prostate cancer (adenocarcinoma).
Also referred to as SKB264, Sac-TMT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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...
- The progression of prostate cancer in the people within 6 months prior to screening shall be determined by the researcher through one of the...
- Soft tissue imaging disease progression determined based on PCWG modified RECIST 1.1 or RECIST 1.1 criteria, regardless of PSA progression. The...
You likely can't join 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...
- Those who require the use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first administration...
- people with central nervous system (CNS) metastases known to have meningeal metastases, brainstem metastases, spinal cord metastases and/or...
See the full eligibility criteria
Who can 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 people 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...
- 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...
- people 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; people 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 people with liver metastasis at baseline, ALT and AST should be ≤ 5 × ULN; Albumin ≥ 30g/L; Total bilirubin (TBIL) ≤...
- 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 people 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...
- The people voluntarily joined this study, signed an informed consent form, and were able to comply with the visit and related procedures specified in the protocol.
What rules you out
- 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...
- 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...
- people with central nervous system (CNS) metastases known to have meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or untreated conditions. For people with brain metastases...
- 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...
- 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)...
- 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 how well it works drugs), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic...
- 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...
- 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...
- people 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...
- 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...
- Known active pulmonary tuberculosis. people 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.