Unresectable Thymic CarcinomaPhase 2XANTHOSNCT07750353
A Phase II, Investigator-Initiated Exploratory Study of Sacituzumab Tirumotecan for Previously Treated Unresectable Thymic Carcinomas
A Phase 2 study testing Sacituzumab Tirumotecan (Sac-TMT) in people with Unresectable Thymic Carcinoma, run by National Cancer Center, Japan at 3 sites in Japan.
Trial summary
This is a non-randomized, open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of sacituzumab tirumotecan (hereafter referred to as sac-TMT) in patients with unresectable thymic carcinoma who have a history of platinum-based combination chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Thymic Carcinoma
- What is being tested?
- Sacituzumab Tirumotecan (Sac-TMT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesJapan
- Study dates
- 1 Feb 2027to Jun 2030
- 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
- Pathologically diagnosed (histological or cytological examination) as thymic carcinoma originating in the thymus or from a metastatic site Immunohistochemical staining including diagnostic marker testing is recommended. If performed prior to registration, the timing is not restricted. However, if histological examination was conducted at another institution, the pathological diagnosis must generally be obtained by a pathologist at the study site, e.g., by requesting the pathological specimen.)
- Meets any of the following criteria:
- Thymic carcinoma was classified as Stage IV by the Masaoka-Koga staging at initial diagnosis
- Thymic carcinoma was classified as Stage III by the Masaoka-Koga staging at initial diagnosis and was judged to be unresectable with curative resection
- The disease is a postoperative recurrence of thymic carcinoma
- The patients do not have symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiation therapy or surgical intervention
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- The patients do not have pericardial effusion, pleural effusion, or ascites requiring treatment
- Age ≥ 18 years at registration
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- At least one measurable lesion on contrast-enhanced CT (brain, neck, chest, abdomen, pelvis: slice thickness ≤ 5 mm) performed within 14 days prior to registration (same day of the week 2 weeks prior to registration date is acceptable; same applies below)
- History of combination chemotherapy including platinum agents for unresectable thymic carcinoma (treatment in this study will be second-line or later)
- No administration of anticancer drugs (chemotherapy, molecularly targeted therapy, immunotherapy, etc.) or other investigational drugs within 28 days prior to the registration date (same day of the week 4 weeks prior to registration date is acceptable; same applies below)
- No surgery under general anesthesia within 28 days prior to the registration date
- No radiation therapy (including gamma knife, cyberknife) within 14 days prior to the registration date
- Laboratory tests performed within 14 days prior to the registration date meet the following criteria #1 to #8. However, no administration of granulocyte colony-stimulating factor (G-CSF) or blood transfusion within 14 days prior to the blood draw date
- Neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 10 × 10⁴/mm³
- Hemoglobin ≥ 9.0 g/dL
- AST ≤ 75 U/L (up to 150 U/L allowed if liver metastases are present)
- ALT ≤ 75 U/L (up to 150 U/L allowed if liver metastases are present)
- Total bilirubin ≤ 1.5 mg/dL
- PT-INR ≤ 1.5
- Creatinine ≤ 1.5 mg/dL (If creatinine > 1.5 mg/dL, eligibility is confirmed if creatinine clearance (CrCl)* ≥ 30 mL/min) *CrCl is calculated using the Cockcroft-Gault formula: [[140-age (years)] × weight (kg)] / [72 × serum creatinine (mg/dL) × 0.85 (for females)]. Alternatively, CrCl may be measured from a 24-hour urine collection.
- Percutaneous oxygen saturation (SpO2) ≥ 92% under room air within 14 days prior to registration date
- Patients with adverse events from prior anticancer therapy must have recovered to Grade 1 or below or to baseline values (excluding alopecia and leukoplakia). If endocrine-related adverse events are present, they must be adequately managed with hormone replacement therapy.
- For males: Agree to the following for at least 120 days after the last dose of study drug:
- Refrain from sperm donation Use condoms during sexual intercourse with non-study participants of childbearing potential, and have the partner use an additional contraceptive method as described in the Appendix 18.2
- For females: Not pregnant or breastfeeding, and meeting at least one of the following conditions:
- The patients do not fall under the definition of a woman of childbearing potential (POCBP, Appendix 18.2)
- Falls under the definition of a woman of childbearing potential and has agreed to the following:
- For at least 210 days from consent to the final study drug administration, use a highly effective (failure rate <1% per year) and low user-dependent contraceptive method as listed in the Appendix 18.2, or have permanently and continuously abstained from penile-vaginal intercourse as a preferred and habitual lifestyle. During this period, the patient agrees not to donate or freeze/store eggs (ova, oocytes) to others. The period required to maintain contraception for the study treatment is from day 0 (final dose) to day 210. The investigator will assess compliance with the contraception requirements (Appendix 18.2) prior to the first study drug dose.
- A negative pregnancy test must be confirmed using either a urine hCG pregnancy test within 14 days prior to the date of enrollment Refer to Appendix 18.2 for additional requirements regarding pregnancy testing during and after study treatment.
- To reduce the risk of including women with very early, undetected pregnancies, the investigator is responsible for confirming the patient's medical history, menstrual history, and recent sexual activity.
- For lactating patients, they must agree not to breastfeed for at least 10 days after the final study drug dose.
- Written informed consent for study participation has been obtained from the patient.
- Patients who have undergone cancer genomic profiling testing and have agreed to provide their C-CAT ID (limited to patients registered within Japan). For patients enrolled in South Korea, genomic profiling results, if available, may be provided for supplementary analyses.
Who cannot join
- Patients with thymoma and immune complications associated with thymoma (such as myasthenia gravis, aplastic anemia, hypogammaglobulinemia (Good syndrome), etc.)
- Patients with intestinal paralysis or intestinal obstruction
- Patients with a history of severe dry eye syndrome, severe meibomian gland disease, or severe corneal disease (impeding or delaying corneal healing)
- Uncontrolled major cardiovascular or cerebrovascular disease (NYHA Class III or IV heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, QTcF interval >480 ms, or other major cardiovascular or cerebrovascular disease within 6 months prior to enrollment
- Patients with unresolved stomatitis greater than Grade 1 at the time of registration are excluded. Prophylactic supportive care measures for stomatitis are permitted, provided there are no active stomatitis-related symptoms.
- Previous treatment history with a TROP2-targeted ADC (such as sacituzumab govitecan)
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- Previous treatment history with topoisomerase I inhibitors (irinotecan, topotecan) or ADCs containing topoisomerase I inhibitors (e.g., trastuzumab deruxtecan)
- Received a live or live-attenuated vaccine within 30 days prior to the registration date. Inactivated vaccines may be administered.
- Currently receiving a strong CYP3A4 inducer/inhibitor (Appendix 18.4) that cannot be discontinued during the treatment period of the protocol treatment. The required washout period prior to the registration date is 14 days.
- Known malignancy that has progressed or required active treatment within the past 3 years.
- Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (except carcinoma in situ of the bladder) who have undergone curative resection are not excluded.
- Note: Untreated patients with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤ 6, PSA < 10 ng/mL) who have undergone curative treatment or whose disease is stable under active surveillance are not excluded.
- Active infection requiring systemic therapy.
- Positive for HIV antibody, HBs antigen, or HCV-RNA (HCV-RNA measured only if HCV antibody is positive).
- HBs antigen negative, HBs antibody or HBc antibody positive, and HBV-DNA quantitative positive (not excluded if below detection limit).
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the investigator or sub-investigator.
- Has a history of severe hypersensitivity (Grade 3 or higher) to the study drug, its excipients, or other biological therapies.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan3 sites
Osaka International Cancer Institute
Chuo-ku, Osaka
Motohiro Tamiya, +81-6-6945-1181
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Yusuke Okuma, M.D., Ph.D., +81-3-3542-2511
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa
Shuji Murakami, +81-45-520-2222
About this study
This is a non-randomized, open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of sacituzumab tirumotecan (hereafter referred to as sac-TMT) in patients with unresectable thymic carcinoma who have a history of platinum-based combination chemotherapy.
- Conditions
- Unresectable Thymic Carcinoma
- Being tested
- Sacituzumab Tirumotecan (Sac-TMT)
- Keywords
- sacituzumab tirumotecan, thymic carcinoma
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Tirumotecan (Sac-TMT)Drug
Sacituzumab tirumotecan at 4 mg/kg is administered intravenously on Day 1 and Day 15 of each 28-day cycle and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. The maximum exposure period for sacituzumab tirumotecan is 78 cycles (approximately 3 years).
| Study group | Role | What they receive |
|---|---|---|
| sacituzumab tirumotecan | Experimental | Not described Receives: Drug: Sacituzumab Tirumotecan (Sac-TMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate based on central image review
The primary endpoint is the objective response rate based on central image review. It is defined as the proportion of patients in the FAS who achieved either a CR or PR based on the best overall response determined by central imaging review.
Measured: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.
Secondary outcomes (6)
Objective response rate based on investigator assessment
The proportion of patients in the FAS group whose best overall response, as assessed by the treating physician at each study site, is either CR or PR.
Measured: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.
Progression-free survival
The period from the registration date to the earlier of the date of progression or the date of death from any cause. Note that PD based on imaging studies will use the institution's assessment.
Measured: From date of enrollment until disease progression or death, whichever occurs first, through study completion, approximately 3 years.
Overall survival
The period from the registration date to the date of death from any cause is considered overall survival.
Measured: From date of enrollment until death, through study completion, approximately 3 years.
Duration of response
The period from the date of initial PR/CR confirmation based on imaging assessment to the earlier of the date of confirmed disease progression or the date of death from any cause. The date of PR/CR confirmation is defined as the first day on which confirmed PR/CR was observed. Definitions for progression and discontinuation are the same as those used for progression-free survival.
Measured: From date of enrollment until death, through study completion, approximately 3 years.
Disease control rate
The proportion of patients among those with FAS whose best overall response, as determined by central imaging review and institutional assessment, was CR, PR, or SD.
Measured: From date of enrollment until disease progression, initiation of post-study treatment, or study completion, approximately 3 years.
Incidence rate of adverse events/incidence rate of adverse reactions
The proportion of patients with each adverse event/adverse reaction among those with SAS. The frequency of the worst grade according to CTCAE v5.0 is calculated for each adverse event/adverse reaction.
Measured: From date of enrollment until death, through study completion, approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Feb 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Thymic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750353
- Sponsor's protocol ID
- NCCH2506/MK017/ATLAS2503
- Acronym
- XANTHOS
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Investigator-Initiated Exploratory Study of Sacituzumab Tirumotecan for Previously Treated Unresectable Thymic Carcinomas
- ClinicalTrials.gov ID
- NCT07750353
- Acronym / sponsor ID
- XANTHOS / NCCH2506/MK017/ATLAS2503
- Conditions
- Unresectable Thymic Carcinoma
- Keywords
- sacituzumab tirumotecan, thymic carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Cancer Center, JapanOther government
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized, open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of sacituzumab tirumotecan (hereafter referred to as sac-TMT) in patients with unresectable thymic carcinoma who have a history of platinum-based combination chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sacituzumab tirumotecan | Experimental | Drug: Sacituzumab Tirumotecan (Sac-TMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Pathologically diagnosed (histological or cytological examination) as thymic carcinoma originating in the thymus or from a metastatic site Immunohistochemical staining including diagnostic marker testing is recommended. If performed prior to registration, the timing is not restricted. However, if histological examination was conducted at another institution, the pathological diagnosis must generally be obtained by a pathologist at the study site, e.g., by requesting the pathological specimen.)
- Meets any of the following criteria:
- The patients do not have symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiation therapy or surgical intervention
- The patients do not have pericardial effusion, pleural effusion, or ascites requiring treatment
- Age ≥ 18 years at registration
Key exclusion criteria (18 listed)
- Patients with thymoma and immune complications associated with thymoma (such as myasthenia gravis, aplastic anemia, hypogammaglobulinemia (Good syndrome), etc.)
- Patients with intestinal paralysis or intestinal obstruction
- Patients with a history of severe dry eye syndrome, severe meibomian gland disease, or severe corneal disease (impeding or delaying corneal healing)
- Uncontrolled major cardiovascular or cerebrovascular disease (NYHA Class III or IV heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, QTcF interval >480 ms, or other major cardiovascular or cerebrovascular disease within 6 months prior to enrollment
- Patients with unresolved stomatitis greater than Grade 1 at the time of registration are excluded. Prophylactic supportive care measures for stomatitis are permitted, provided there are no active stomatitis-related symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Tirumotecan (Sac-TMT)Sacituzumab tirumotecan at 4 mg/kg is administered intravenously on Day 1 and Day 15 of each 28-day cycle and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. The maximum exposure period for sacituzumab tirumotecan is 78 cycles (approximately 3 years). | Drug | sacituzumab tirumotecan |
Primary outcome
Objective response rate based on central image review
Time frame: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.
The primary endpoint is the objective response rate based on central image review. It is defined as the proportion of patients in the FAS who achieved either a CR or PR based on the best overall response determined by central imaging review.
6 secondary outcomes
Objective response rate based on investigator assessment
Time frame: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.
Progression-free survival
Time frame: From date of enrollment until disease progression or death, whichever occurs first, through study completion, approximately 3 years.
Overall survival
Time frame: From date of enrollment until death, through study completion, approximately 3 years.
Duration of response
Time frame: From date of enrollment until death, through study completion, approximately 3 years.
Disease control rate
Time frame: From date of enrollment until disease progression, initiation of post-study treatment, or study completion, approximately 3 years.
Incidence rate of adverse events/incidence rate of adverse reactions
Time frame: From date of enrollment until death, through study completion, approximately 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Unresectable Thymic Carcinoma
Active, not recruitingPhase 2
Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer
Thymic Carcinoma
RecruitingPhase 1
Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
Stage III Thymoma AJCC v8, Stage IIIA Thymoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan (Sac-TMT) in people with Unresectable Thymic Carcinoma, run by National Cancer Center, Japan at 3 sites in Japan.
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 36 inclusion and 18 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 Yusuke Okuma, M.D., Ph.D. (+81-3-3542-2511, NCCH2506_office@ml.res.ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate based on central image review (time frame: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.