| Eligibility |
Inclusion 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 enrollment after consultation with the
Principal Investigator
- 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 have been treated. For patients with
HCV infection who are currently on treatment, they are eligible if they have an
undetectable HCV viral load.
- Patients with prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
- 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 during this same period.
- 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 undergone surgical
sterilization (removal of ovaries and/or uterus). The definition of childbearing
potential may be adapted for alignment with local guidelines or requirements.
- 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 copper
intrauterine devices.
- 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, symptothermal, or
postovulation methods) and withdrawal are not adequate methods of contraception.
- 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 rate of < 1% per year
during the treatment period and for 90 days after the final dose of sacituzumab
govitecan-hziy. Men must refrain from donating sperm during this this same
period.
- 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, symptothermal, or
postovulation methods) and withdrawal are not adequate methods of contraception.
Exclusion Criteria:
- 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 interpretation of the results, or may render
the patient at high risk from treatment complications.
- 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
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