A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors

Trial Title: A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors

NCT ID: NCT06248515

Condition: Thymoma
Thymic Carcinoma

Conditions: Official terms:
Carcinoma
Thymoma
Thymus Neoplasms
Sacituzumab govitecan

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Sacituzumab govitecan-hziy
Description: 10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles
Arm group label: Sacituzumab

Summary: 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? Participants will: - receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity - have regular blood tests, scans, and examinations to monitor their health. - have blood and a biopsy of their tumor for research purposes.

Criteria for eligibility:
Criteria:
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) /= 30 mL/min (calculated using the Cockcroft-Gault formula, see Appendix 2) - For patients not receiving therapeutic anticoagulation: INR and aPTT /= 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Lombardi Comprehensive Cancer Center, Georgetown University

Address:
City: Washington
Zip: 20007
Country: United States

Status: Recruiting

Contact:
Last name: Emma Dimeo

Phone: 202-784-5067
Email: ed889@georgetown.edu

Investigator:
Last name: Chul Kim, MD
Email: Principal Investigator

Start date: April 25, 2024

Completion date: December 2026

Lead sponsor:
Agency: Georgetown University
Agency class: Other

Collaborator:
Agency: Gilead Sciences
Agency class: Industry

Source: Georgetown University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06248515