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

NCT06248515 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00007501
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Thymic Carcinoma; Thymoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Objective response is defined a confirmed overall response of complete response (CR) or partial response (PR) as assessed by RECIST v1.1. The objective response rate (ORR) will be estimated number of evaluable patients with a documented objective response divided by the total number of evaluable patients.

  1 year

Secondary Outcomes (3)

• Duration of response (DOR)

  1 year

• Progression-free survival (PFS)

  1 year

• Overall survival (OS)

  1 year

Study Arms (1)

Sacituzumab

EXPERIMENTAL

Drug: Sacituzumab govitecan-hziy

Interventions

Sacituzumab govitecan-hziy DRUG

10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles

Sacituzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• Gilead Sciences: collaborator

Study Sites (4)

Stanford Cancer Institute

Palo Alto, California, 94304, United States

RECRUITING

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

MeSH Terms

Conditions

Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Chul Kim, MD

  Chul.Kim@gunet.georgetown.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chul Kim, MD

CONTACT

202-444-2223; Chul.Kim@gunet.georgetown.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: April 25, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)