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Thymic Epithelial TumorsPhase 2NCT07343453

A Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Second-Line and Subsequent Treatments for Advanced Thymic Epithelial Tumors

A Phase 2 study testing Sacituzumab tirumotecan in people with Thymic Epithelial Tumors and Advanced Stage, run by Sun Yat-sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a single-arm, phase II study to evaluate the efficacy and safety of Sacituzumab Tirumotecan, a TROP2-directed antibody-drug conjugate, in patients with advanced thymic epithelial tumors who have received second-line or later therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab tirumotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
No sites listed yet
Study dates
22 Dec 2025to 22 Dec 2029
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

  • Advanced (unresectable or metastatic) thymic epithelial tumor confirmed by histology or cytology.
  • Progress after receiving at least first-line systemic therapy (chemotherapy or immune checkpoint inhibitor).
  • According to RECISTv1.1 standard, there is at least one measurable lesion.
  • No central nervous system metastasis or stable brain metastasis after treatment (asymptomatic and hormone withdrawal for ≥4 weeks).
  • Age > 18 years old, male or female.
  • ECOG (Performance status, PS) score 0-1.
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  • Expected survival time ≥12 weeks.
  • Organ function compliance (confirmed by laboratory examination within 14 days before treatment): Bone marrow function: I. Neutrophils ≥ 1500× 109/L; Ii. Platelets ≥ 100× 109/L; Iii. hemoglobin > 90g/l; Renal function: I. Serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl). ≥50mL/min； Ii. Urine protein < 2+or 24H urine protein quantitative < <1.0g；; Liver function: I, AST or ALT ≤ 3× ULN; For patients with liver metastasis, it can ≤5*ULN； Ii. Total bilirubin ≤1.5×ULN, and liver metastasis patients ≤ 3× ULN; Iii: serum albumin (ALB) ≥ 28g/l; Coagulation function: NR or APTT≤1.5×ULN；; Cardiac function: Left ejection fraction (LEFF) ≥ 50%.
  • Before making any evaluation related to the study, the subjects must understand and volunteer. Sign the informed consent form and voluntarily comply with other requirements of the study.
  • Female subjects with reproductive function must be treated within 3 days before the first medication. Urine or serum pregnancy test (if the result of urine pregnancy test cannot be confirmed as negative, serum pregnancy test is needed, and the serum pregnancy result shall prevail). If a fertile woman has sex with an unsterilized male partner, the subjects agree to continue using contraception and avoid breastfeeding during the medication.
  • Male subjects are willing to agree to continue using contraception during the medication.

Who cannot join

  • Previously received targeted drug therapy with Lucasatuzumab.
  • Have received any drug therapy targeting topoisomerase I in the past, including antibody-coupled drug (ADC) therapy.
  • Patients with grade 3-4 interstitial lung disease.
  • Subjects known to have meningeal metastasis, brain stem metastasis, spinal cord metastasis and/or compression, active or brain metastasis without local treatment. 5.Subjects with brain metastases who have previously received local treatment can participate in the study if they are clinically stable for at least 4 weeks before the first administration of the study treatment and do not need to use corticosteroids or anticonvulsants for at least 14 days before the first administration; For the subjects with brain metastases first discovered during screening, if they receive local treatment (such as radiotherapy), they must have imaging evidence to show that the brain metastases have not progressed for at least 4 weeks from the first imaging diagnosis of brain metastases, and they can only enter the group after confirming that the brain metastases are stable.
  • Patients with previous malignant tumors (except skin malignant tumors other than melanoma, and carcinoma in situ in the following parts [bladder, stomach, colorectal cancer, endometrium, cervix, melanoma or breast]) cannot be included in this study. However, if the malignant tumor has achieved complete remission for five years or more, and no additional anti-tumor treatment is needed during this study, it can be included in the study.
  • Myocardial infarction and uncontrolled arrhythmia occurred within 6 months before the first administration (including QTc interval ≥450ms for men and ≥ 470 ms for women) (QTc interval is calculated by Fridericia formula); Or grade III-IV cardiac insufficiency according to NYHA standard or left ventricular ejection fraction < 50% by color Doppler echocardiography.
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  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. Only a small amount of pleural effusion, a small amount of ascites and a small amount of pericardial effusion without clinical symptoms shown by imaging can be included in the group.
  • Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding.
  • Patients with active hepatitis B, hepatitis C, tuberculosis and syphilis or other serious infections with poor clinical control.
  • HIV positive or diagnosed with acquired immunodeficiency disease (AIDS).
  • Known allergic to the study drug or any of its components (including polysorbate -20), known history of severe hypersensitivity to other monoclonal antibodies (NCI-CTCAE5.0 grade is greater than grade 3).
  • Before the first administration, he was receiving long-term systemic corticosteroid therapy of > 10mg of prednisone or equivalent dose of systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy. Subjects who need bronchodilators, inhaled or topical steroids or local steroid injections, and who are used as preventive drugs for hypersensitivity (such as drugs before CT examination) may be admitted into the group.
  • Known history of hereditary bleeding tendency disease or coagulation dysfunction.
  • Pregnant or lactating women.
  • During the screening before the first administration, the condition deteriorated rapidly, such as serious changes in physical state.
  • The researcher thinks that the patient can't finish the study medically, psychologically or physically or can't understand the information in the patient manual.
  • Those who have been vaccinated with live or attenuated vaccines within 28 days before the first administration or have plans to vaccinate such vaccines during the study period; However, inactivated virus vaccines for seasonal influenza are allowed to be used.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xue Hou contact

+86 13570569436

houxue@sysucc.org.cn

About this study

This is a single-arm, phase II study to evaluate the efficacy and safety of Sacituzumab Tirumotecan, a TROP2-directed antibody-drug conjugate, in patients with advanced thymic epithelial tumors who have received second-line or later therapy.

Read the detailed description

This study aims to evaluate the efficacy and safety of Sacituzumab Tirumotecan, a TROP2-directed antibody-drug conjugate, in patients with advanced thymic epithelial tumors who have received second-line or later therapy. The study is designed as a prospective, single-arm, phase II clinical trial. Eligible patients must meet the inclusion/exclusion criteria, have received prior systemic therapy, and have a pathological diagnosis of advanced thymic epithelial tumor. Enrolled patients will receive Sacituzumab Tirumotecan at a dose of 5 mg/kg via intravenous infusion. Treatment cycles repeat every 4 weeks, with administration on Day 1 and Day 15 of each cycle. Treatment will continue until disease progression (as defined by loss of clinical benefit), intolerable toxicity, patient withdrawal, or meeting other protocol-specified discontinuation criteria. The primary endpoint of this study is the Objective Response Rate (ORR), defined as the proportion of patients achieving a confirmed Complete Response (CR) or Partial Response (PR) as their best overall response, assessed according to RECIST version 1.1. Secondary endpoints include Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (OS), incidence of Adverse Events (AEs), and Quality of Life (QoL) assessments. Following treatment discontinuation, subjects will enter a follow-up phase consisting of safety follow-up and survival follow-up, with survival status assessed every 90 days.

Being tested
Sacituzumab tirumotecan

What participants receive

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

  • Sacituzumab tirumotecanDrug

    Sacituzumab Tirumotecan is an antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 monoclonal antibody of the IgG1 class covalently linked to the cytotoxic payload KL610023, a topoisomerase I inhibitor. Its mechanism of action involves: (1) specific binding of the antibody to Trop-2 on the tumor cell membrane, followed by internalization; (2) lysosomal degradation leading to the release of SN-38, which induces DNA double-strand breaks; and (3) a bystander effect that kills adjacent Trop-2-negative cells.

Study groups in NCT07343453
Study groupRoleWhat they receive
Sacituzumab TirumotecanExperimentalSacituzumab Tirumotecan, 5 mg/kg, iv. drip, D1 and D15, Q4W. Treatment will continue until disease progression (as defined by loss of clinical benefit), intolerable toxicity, patient withdrawal, or meeting other protocol-specified discontinuation criteria.
Receives: Drug: Sacituzumab tirumotecan

What is being measured

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

  1. Objective response rate（ORR）

    ORR, per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).

    Measured: Within one year after starting treatment.

Secondary outcomes (4)

  1. Progression free survival （PFS）

    The time interval from the first dose of study medication to the first record of disease progression or death from any cause, whichever occurred first.

    Measured: Within two year after the first treatment

  2. Disease control rate (DCR)

    The proportion of subjects who achieved the best total efficacy was to confirm CR or PR or SD (according to iRECIST).

    Measured: Within one year after starting treatment.

  3. Duration of remission (DOR)

    The time from the first record of confirmed remission (CR or PR) to the first record of disease progression (according to irecist) or death due to any cause, whichever occurs first.

    Measured: Within one year after starting treatment.

  4. Overall survival (OS)

    OS is defined as the time from the first administration of the study drug until the date of death from any cause. For subjects who are alive at the data cutoff, censoring will occur at the last known date of survival. Subjects with no follow-up information provided will be censored on the date of enrollment.

    Measured: Assessed from enrollment to death or last known survival, up to 4 years post-enrollment.

Timeline

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

  1. First posted15 Jan 2026
  2. Study start22 Dec 2025 (estimated)
  3. Primary completion22 Dec 2027 (estimated)
  4. Study completion22 Dec 2029 (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
Model description
Sacituzumab Tirumotecan
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07343453
Sponsor's protocol ID
B2025-864-02
Status last verified
Jan 2026
First submitted
6 Jan 2026
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Flechon A, Jain RK, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos CE, Pouessel D, Sternberg CN, Hong Q, Goswami T, Itri LM, Grivas P. TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021 Aug 1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.

    PubMed 33929895

  • Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Gomez Pardo P, Jhaveri KL, Delaney R, Valdez T, Wang H, Motwani M, Yoon OK, Verret W, Tolaney SM. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1423-1433. doi: 10.1016/S0140-6736(23)01245-X. Epub 2023 Aug 23.

    PubMed 37633306

  • Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortes J, O'Shaughnessy J, Dieras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485.

    PubMed 33882206

  • Lombardi P, Filetti M, Falcone R, Altamura V, Paroni Sterbini F, Bria E, Fabi A, Giannarelli D, Scambia G, Daniele G. Overview of Trop-2 in Cancer: From Pre-Clinical Studies to Future Directions in Clinical Settings. Cancers (Basel). 2023 Mar 13;15(6):1744. doi: 10.3390/cancers15061744.

    PubMed 36980630

  • Dum D, Taherpour N, Menz A, Hoflmayer D, Volkel C, Hinsch A, Gorbokon N, Lennartz M, Hube-Magg C, Fraune C, Bernreuther C, Lebok P, Clauditz TS, Jacobsen F, Sauter G, Uhlig R, Wilczak W, Steurer S, Minner S, Marx AH, Simon R, Burandt E, Krech T, Luebke AM. Trophoblast Cell Surface Antigen 2 Expression in Human Tumors: A Tissue Microarray Study on 18,563 Tumors. Pathobiology. 2022;89(4):245-258. doi: 10.1159/000522206. Epub 2022 Apr 27.

    PubMed 35477165

  • Ardeshir-Larijani F, Maniar R, Goyal S, Loehrer PJ, Hou T, DeBrock V, Mesa H. Trop-2 Expression and Its Impact on Survival in Thymic Epithelial Tumors: Brief Report. Clin Lung Cancer. 2024 Mar;25(2):180-185.e1. doi: 10.1016/j.cllc.2024.01.001. Epub 2024 Jan 2. No abstract available.

    PubMed 38242729

  • Kurokawa K, Asao T, Hayashi T, Kishikawa S, Kanamori K, Shukuya T, Miyashita Y, Nakamura I, Miyawaki T, Kanemaru R, Mimori T, Mitsuishi Y, Tajima K, Shimada N, Takahashi F, Takamochi K, Suzuki K, Takahashi K. Trophoblast Cell Surface Antigen 2 Expression in Thymic Carcinoma: Brief Report. JTO Clin Res Rep. 2024 May 29;5(7):100693. doi: 10.1016/j.jtocrr.2024.100693. eCollection 2024 Jul.

    PubMed 39034967

  • Yeung V, Zaemes J, Yeh J, Giancarlo C, Ahn J, Reuss JE, Kallakury BV, Liu SV, Duttargi A, Khan G, Kim C. High levels of expression of Trop-2 in thymic epithelial tumors. Lung Cancer. 2023 Oct;184:107324. doi: 10.1016/j.lungcan.2023.107324. Epub 2023 Aug 9.

    PubMed 37573703

  • Huang Q, Zhu L, Liu Y, Zhang Y. Thymic epithelial tumor medical treatment: A narrative review. Biochim Biophys Acta Rev Cancer. 2024 Sep;1879(5):189167. doi: 10.1016/j.bbcan.2024.189167. Epub 2024 Aug 6.

    PubMed 39117091

  • Girard N, Ruffini E, Marx A, Faivre-Finn C, Peters S; ESMO Guidelines Committee. Thymic epithelial tumours: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v40-55. doi: 10.1093/annonc/mdv277. No abstract available.

    PubMed 26314779

  • Li Y, Jiang A, Zhao Y, Shi C, Ma Y, Fu X, Liang X, Tian T, Ruan Z, Yao Y. A novel risk classifier for predicting the overall survival of patients with thymic epithelial tumors based on the eighth edition of the TNM staging system: A population-based study. Front Endocrinol (Lausanne). 2022 Dec 6;13:1050364. doi: 10.3389/fendo.2022.1050364. eCollection 2022.

    PubMed 36561557

  • Marx A, Willcox N, Leite MI, Chuang WY, Schalke B, Nix W, Strobel P. Thymoma and paraneoplastic myasthenia gravis. Autoimmunity. 2010 Aug;43(5-6):413-27. doi: 10.3109/08916930903555935.

    PubMed 20380583

  • Cheng M, Anderson MS. Thymic tolerance as a key brake on autoimmunity. Nat Immunol. 2018 Jul;19(7):659-664. doi: 10.1038/s41590-018-0128-9. Epub 2018 Jun 20.

    PubMed 29925986

  • Kurokawa K, Shukuya T, Greenstein RA, Kaplan BG, Wakelee H, Ross JS, Miura K, Furuta K, Kato S, Suh J, Sivakumar S, Sokol ES, Carbone DP, Takahashi K. Genomic characterization of thymic epithelial tumors in a real-world dataset. ESMO Open. 2023 Oct;8(5):101627. doi: 10.1016/j.esmoop.2023.101627. Epub 2023 Sep 12.

    PubMed 37703595

  • Radovich M, Pickering CR, Felau I, Ha G, Zhang H, Jo H, Hoadley KA, Anur P, Zhang J, McLellan M, Bowlby R, Matthew T, Danilova L, Hegde AM, Kim J, Leiserson MDM, Sethi G, Lu C, Ryan M, Su X, Cherniack AD, Robertson G, Akbani R, Spellman P, Weinstein JN, Hayes DN, Raphael B, Lichtenberg T, Leraas K, Zenklusen JC; Cancer Genome Atlas Network; Fujimoto J, Scapulatempo-Neto C, Moreira AL, Hwang D, Huang J, Marino M, Korst R, Giaccone G, Gokmen-Polar Y, Badve S, Rajan A, Strobel P, Girard N, Tsao MS, Marx A, Tsao AS, Loehrer PJ. The Integrated Genomic Landscape of Thymic Epithelial Tumors. Cancer Cell. 2018 Feb 12;33(2):244-258.e10. doi: 10.1016/j.ccell.2018.01.003.

    PubMed 29438696

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab tirumotecan in people with Thymic Epithelial Tumors and Advanced Stage, run by Sun Yat-sen University.

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 11 inclusion and 17 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Xue Hou (+86 13570569436, houxue@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate（ORR） (time frame: Within one year after starting treatment.). 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 NCT07343453, which also lists 18 linked publications.

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 15 Jan 2026.

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