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New treatment option for Thymoma
Official title A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
ClinicalTrials.gov ID: NCT06248515
What this study is testing
What is Sacituzumab govitecan-hziy?
Sacituzumab govitecan-hziy is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for thymoma.
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
- The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy. The main question it aims to answer is: What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma?
- 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
You may be able to join if
- Age \>/= 18 years at time of signing informed consent form (ICF)
- Ability to understand and the willingness to sign a written informed consent document
- Patients with histologically confirmed advanced thymoma or thymic carcinoma
- Patients who have experienced disease progression after treatment with at least one prior systemic therapy
- Measurable disease per RECIST v1.1
You likely can't join if
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the view of the investigator...
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.
- Symptomatic brain metastasis requiring corticosteroids. Patients with treated brain metastases are eligible.
- No concurrent therapy with approved or investigational anticancer therapeutics
See the full eligibility criteria
- Age \>/= 18 years at time of signing informed consent form (ICF)
- Ability to understand and the willingness to sign a written informed consent document
- Patients with histologically confirmed advanced thymoma or thymic carcinoma
- Patients who have experienced disease progression after treatment with at least one prior systemic therapy
- Measurable disease per RECIST v1.1
- Availability of pre-treatment tumor tissue (archival or fresh); If archival tissue is not available and a fresh biopsy is not considered safe and medically feasible by the Investigator, the patient may be approved for...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- Absolute neutrophil count (ANC) \>/= 1.5 x 10\^9/L (1500/uL) without filgrastim support
- Platelet count \>/= 100 x 10\^9/L (100,000/uL) without transfusion
- Hemoglobin (Hgb) \>/= 80 g/L (8 g/dL). Patients may be transfused to meet this criterion.
- Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) \</= 2.5 x upper limit of normal (ULN), with the following exceptions:
- Patients with documented liver metastases: AST and ALT \</= 5 x ULN
- Patients with documented liver or bone metastases: ALP \</= 5 x ULN Serum bilirubin \</= 1.5 x ULN with the following exception: patients with known Gilbert disease: serum bilirubin \</= 3 x ULN
- Creatinine clearance \>/= 30 mL/min (calculated using the Cockcroft-Gault formula, see Appendix 2)
- For patients not receiving therapeutic anticoagulation: INR and aPTT \</= 1.5 x ULN
- Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must...
- Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
- Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 6 months after the final dose of study treatment. Women must refrain from donating eggs...
- A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (\>/= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not...
- Examples of contraceptive methods with a failure rate of \> 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and...
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation...
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
- With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure...
- With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and 90 days after the final dose of sacituzumab govitecan-hziy to avoid potential exposure to the embryo.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation...
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the view of the investigator, contraindicates the use of an investigational drug, may affect the...
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.
- Symptomatic brain metastasis requiring corticosteroids. Patients with treated brain metastases are eligible.
- No concurrent therapy with approved or investigational anticancer therapeutics
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Hackensack, New Jersey, United States
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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; Hackensack, New Jersey, United States. 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.