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ThymomaPhase 2NCT06248515

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

A Phase 2 study testing Sacituzumab govitecan-hziy in people with Thymoma and Thymic Carcinoma, run by Georgetown University at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thymoma, Thymic Carcinoma
What is being tested?
Sacituzumab govitecan-hziy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesUnited States
Study dates
25 Apr 2024to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 28Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chul Kim, MD contact

202-444-2223

Chul.Kim@gunet.georgetown.edu

United States4 sites, 4 recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Paige Pribble, 773-702-8133, ppribble@bsd.uchicago.edu

    Marina Garassino, MD

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org

    Martin Gutierrez, MD

    Recruiting

  • Stanford Cancer Institute

    Palo Alto, California, 94304

    Monica Loza, 650-724-1430, lozam@stanford.edu

    Heather A Wakelee, MD

    Recruiting

  • Lombardi Comprehensive Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

    Matt Hayhurst, 202-784-3877, mh2340@georgetown.edu

    Chul Kim, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Parallel Arm Study of SACITUZUMAB GOVITECAN-HZIY in Patients With Advanced Thymoma and Thymic Carcinoma

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.
Being tested
Sacituzumab govitecan-hziy
Medical subject headings
Thymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab govitecan-hziyDrug

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

Study groups in NCT06248515
Study groupRoleWhat they receive
SacituzumabExperimentalNot described
Receives: Drug: Sacituzumab govitecan-hziy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (3)

  1. Duration of response (DOR)

    DOR will be evaluated in evaluable patients who had a documented objective response. This is the time from the documented objective response, as assessed by RECIST v1.1, until disease progression or death, whichever occurs first. Patients who are alive without a documented disease progression will be censored at the time of their last disease evaluation.

    Measured: 1 year

  2. Progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from the time of treatment initiation until disease progression or death, whichever occurs first. Patients who are alive without a documented progression will be censored at the time of their last disease evaluation

    Measured: 1 year

  3. Overall survival (OS)

    Overall survival (OS) is defined as the time of treatment initiation until death. Patients who are alive will be censored at the time of their last contact.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start25 Apr 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06248515
Sponsor's protocol ID
STUDY00007501
Status last verified
May 2026
First submitted
31 Jan 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab govitecan-hziy in people with Thymoma and Thymic Carcinoma, run by Georgetown University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chul Kim, MD (202-444-2223, Chul.Kim@gunet.georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06248515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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