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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Georgetown University
Study ID
NCT06248515
Phase
PHASE2
Status
Recruiting

Conditions

  • Thymic Carcinoma
  • Thymoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab govitecan-hziy — DRUG
    10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles

Study Details

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.

Key Dates

Start date
Apr 25, 2024
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstitutePalo AltoCalifornia94304
Monica Loza
650-724-1430
Heather A Wakelee, MD (PRINCIPAL_INVESTIGATOR)
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington D.C.District of Columbia20007
Matt Hayhurst
202-784-3877
Chul Kim, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois60637
Paige Pribble
773-702-8133
Marina Garassino, MD (PRINCIPAL_INVESTIGATOR)
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
551-996-1777
Martin Gutierrez, MD (PRINCIPAL_INVESTIGATOR)

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