Salivary Gland CancerPhase 2TROP2NCT06923826
Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC)
A Phase 2 study testing Sacituzumab govitecan in people with Salivary Gland Cancer and Thyroid Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to learn if the drug, sacituzumab govitecan, works to treat: 1. Salivary gland cancers that have spread to other parts of the body or come back after previous treatment, and cannot be removed by surgery 2. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Salivary Gland Cancer, Thyroid Cancer
- What is being tested?
- Sacituzumab govitecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Apr 2025to Apr 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants (or legally acceptable representative if applicable) provide written consent for the trial.
- At least 21 years of age on the day of signing informed consent.
- Have histologically or cytologically confirmed diagnosis of advanced or unresectable salivary gland cancer or thyroid cancer, not amenable to local treatment.
- Have measurable disease based on RECIST 1.1.
- Patients with metastatic or recurrent unresectable advanced salivary gland cancers must have progressive disease within the previous 6 months and have seen at least 1 prior line of systemic treatment, unless the patients had contraindications to the systemic treatment considered standard of care or there was no standard of care for that particular salivary gland histological subtype.
- Patients with unresectable metastatic or recurrent RAI refractory differentiated thyroid carcinoma, must have progressive disease within the previous 13 months and have seen at least 1 prior line of tyrosine kinase inhibitor (TKI), unless the patients had contraindications to the TKIs. Prior next generation sequencing is not mandated, but if known to harbour somatic pathogenic RET alteration or NTRK gene fusion, then the patient must have received 2 prior lines of TKIs, unless the patients had contraindications to the TKIs or declined the 2nd line of TKIs.
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- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have an adequate organ function. Specimens must be collected within 10 days prior to the start of study treatment.
- Provision of blood and tumour tissue samples (newly obtained biopsy if clinically feasible or archival specimen) to support exploratory biomarker analysis.
Who cannot join
- Has untreated brain metastases or leptomeningeal metastases.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
- Has received prior radiotherapy within 2 weeks of the start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known severe hypersensitivity reaction to Sacituzumab govitecan.
- Has an active infection requiring systemic treatment. This includes TB (Bacillus Tuberculosis).
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- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Recent cardiovascular thromboembolic event, such as the following:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 4 weeks before enrolment
- Symptomatic pulmonary embolism ≤ 4 weeks before enrolment
- Any history of acute myocardial infarction ≤ 6 months before enrolment
- Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤ 6 months before enrolment
- Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before enrolment
- Any history of cerebrovascular accident ≤ 6 months before enrolment
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative for subject to start receiving study medication.
- Is not willing to practice contraception during the study, and for up to a period of at least 6 months after the last dose of SG:
- A woman of childbearing potential who does not agree to follow the contraceptive guidance on the use of effective contraception during the treatment period and for at least 6 months after the last dose of study medication.
- A male participant who does not agree to the use of effective contraception during the treatment period and for at least 3 months after the last dose of study treatment, and to refrain from donating sperm during this period.
- History of having received a live virus vaccination (e.g., yellow fever, MMR, nasal flu, chicken pox or Zostavax) within 4 weeks prior to the first dose of trial treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Cancer Institute Singapore
Singapore, 119074
Boon Cher Prof Goh, MD, +65 6908 2222, phcgbc@nus.edu.sg
Wan Qin Dr Chong, MD, +65 6908 2222, wan_qin_chong@nuhs.edu.sg
About this study
Official title: Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC) - A Phase 2 Multi-centre Trial
The goal of this clinical trial is to learn if the drug, sacituzumab govitecan, works to treat:
- Salivary gland cancers that have spread to other parts of the body or come back after previous treatment, and cannot be removed by surgery
- A type of thyroid cancer (specifically, differentiated thyroid carcinoma) that has spread to other parts of the body or come back after previous treatment, no longer responds to radioactive iodine treatment and cannot be removed by surgery
Read more
The main question it aims to answer is whether sacituzumab govitecan can treat the 2 conditions mentioned above in a safe and effective manner.
Participants will:
- Receive sacituzumab govitecan by intravenous (IV) infusion on Day 1 and Day 8 of each treatment cycle. Each treatment cycle is 21 days (3 weeks) long.
- Visit the clinic before each infusion for checkups and blood tests
- Go through CT/PET/MRI scan once every 6 weeks for the first 24 weeks, then every 9 weeks thereafter.
- Go through 2 tumour biopsies (if assessed by the doctor to be safe) at the start and at the end of study participation
Participants will continue to receive treatment with sacituzumab govitecan until their cancer stops responding to the drug or if they decide to withdraw from the study.
- Conditions
- Salivary Gland Cancer, Thyroid Cancer
- Being tested
- Sacituzumab govitecan
- Keywords
- salivary gland cancer, Sacituzumab govitecan, thyroid cancer
- Medical subject headings
- Salivary Gland Neoplasms, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecanDrug
Also called Trodelvy
Day 1 and Day 8: Sacituzumab Govitecan will be administered at the dose of 10 mg/kg via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Participants with metastatic/ recurrent salivary gland cancers such as adenoid cystic carcinoma, mucoepidermoid carcinoma, adenocarcinoma NOS and salivary duct carcinoma.
Each treatment cycle is 3 weeks. Treatment will be continued till disease progression, unacceptable toxicity or withdrawal of consent Receives: Drug: Sacituzumab govitecan |
| Cohort B | Experimental | Participants with metastatic/ recurrent well-differentiated or poorly differentiated radioactive iodine (RAI) refractory thyroid carcinoma. Each treatment cycle is 3 weeks. Treatment will be continued till disease progression, unacceptable toxicity or withdrawal of consent. Receives: Drug: Sacituzumab govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the as the percentage of participants with a complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumours (RECIST) version 1.1.
Measured: Up to 3 years
Secondary outcomes (4)
Progression free survival (PFS)
PFS is defined as the time from treatment assignment to disease progression or death, whichever occurs first
Measured: From date of treatment assignment until first documented progression or date of death, whichever occurs earlier, assessed up to 3 years
Incidence of Treatment-Related Adverse Events (TRAEs)
The frequency and outcome of TRAEs as assessed and graded according to the CTCAE version 5.0.
Measured: From date of informed consent till 90 days following the date of last dose of study treatment.
6-months Disease control rate (DCR)
6-months DCR is defined to be the percentage of participants with a complete response (CR), partial response (PR) or stable disease (SD) noted as the objective response status, according to RECIST version 1.1, at 6 months after initiating study treatment.
Measured: Up to 6 months after initiating study treatment.
Correlation of ORR with Trop-2 expression in tumour samples
Relationship between ORR and Trop-2 expression levels measured in tumour samples.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start15 Apr 2025
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Salivary Gland CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Wan Qin Dr Chong, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923826
- Sponsor's protocol ID
- ECOS Ref. 2024-3605
- Other IDs
- CO-US-979-7131
- Acronym
- TROP2
- Status last verified
- Nov 2024
- First submitted
- 12 Mar 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Explain why IPD will not or might not be shared.
Publications
Cubas R, Zhang S, Li M, Chen C, Yao Q. Trop2 expression contributes to tumor pathogenesis by activating the ERK MAPK pathway. Mol Cancer. 2010 Sep 21;9:253. doi: 10.1186/1476-4598-9-253.
PubMed 20858281Schlumberger M, Brose M, Elisei R, Leboulleux S, Luster M, Pitoia F, Pacini F. Definition and management of radioactive iodine-refractory differentiated thyroid cancer. Lancet Diabetes Endocrinol. 2014 May;2(5):356-8. doi: 10.1016/S2213-8587(13)70215-8. Epub 2014 Jan 30. No abstract available.
PubMed 24795243Shulin JH, Aizhen J, Kuo SM, Tan WB, Ngiam KY, Parameswaran R. Rising incidence of thyroid cancer in Singapore not solely due to micropapillary subtype. Ann R Coll Surg Engl. 2018 Apr;100(4):295-300. doi: 10.1308/rcsann.2018.0004. Epub 2018 Mar 15.
PubMed 29543059Mahmood U, Koshy M, Goloubeva O, Suntharalingam M. Adjuvant radiation therapy for high-grade and/or locally advanced major salivary gland tumors. Arch Otolaryngol Head Neck Surg. 2011 Oct;137(10):1025-30. doi: 10.1001/archoto.2011.158.
PubMed 22006781Licitra L, Cavina R, Grandi C, Palma SD, Guzzo M, Demicheli R, Molinari R. Cisplatin, doxorubicin and cyclophosphamide in advanced salivary gland carcinoma. A phase II trial of 22 patients. Ann Oncol. 1996 Aug;7(6):640-2. doi: 10.1093/oxfordjournals.annonc.a010684.
PubMed 8879381Guan H, Guo Z, Liang W, Li H, Wei G, Xu L, Xiao H, Li Y. Trop2 enhances invasion of thyroid cancer by inducing MMP2 through ERK and JNK pathways. BMC Cancer. 2017 Jul 14;17(1):486. doi: 10.1186/s12885-017-3475-2.
PubMed 28709407Rugo 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 37633306Paz-Ares LG, Juan-Vidal O, Mountzios GS, Felip E, Reinmuth N, de Marinis F, Girard N, Patel VM, Takahama T, Owen SP, Reznick DM, Badin FB, Cicin I, Mekan S, Patel R, Zhang E, Karumanchi D, Garassino MC. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733. Epub 2024 May 31.
PubMed 38843511
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC) - A Phase 2 Multi-centre Trial
- ClinicalTrials.gov ID
- NCT06923826
- Acronym / sponsor ID
- TROP2 / ECOS Ref. 2024-3605
- Conditions
- Salivary Gland Cancer, Thyroid Cancer
- Keywords
- salivary gland cancer, Sacituzumab govitecan, thyroid cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 11 Apr 2025 (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.
The goal of this clinical trial is to learn if the drug, sacituzumab govitecan, works to treat:
- Salivary gland cancers that have spread to other parts of the body or come back after previous treatment, and cannot be removed by surgery
- A type of thyroid cancer (specifically, differentiated thyroid carcinoma) that has spread to other parts of the body or come back after previous treatment, no longer responds to radioactive iodine treatment and cannot be removed by surgery
The main question it aims to answer is whether sacituzumab govitecan can treat the 2 conditions mentioned above in a safe and effective manner.
Participants will:
- Receive sacituzumab govitecan by intravenous (IV) infusion on Day 1 and Day 8 of each treatment cycle. Each treatment cycle is 21 days (3 weeks) long.
- Visit the clinic before each infusion for checkups and blood tests
- Go through CT/PET/MRI scan once every 6 weeks for the first 24 weeks, then every 9 weeks thereafter.
- Go through 2 tumour biopsies (if assessed by the doctor to be safe) at the start and at the end of study participation
Participants will continue to receive treatment with sacituzumab govitecan until their cancer stops responding to the drug or if they decide to withdraw from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Sacituzumab govitecanParticipants with metastatic/ recurrent salivary gland cancers such as adenoid cystic carcinoma, mucoepidermoid carcinoma, adenocarcinoma NOS and salivary duct carcinoma. Each treatment cycle is 3 weeks. Treatment will be continued till disease progression, unacceptable toxicity or withdrawal of consent |
| Cohort B | Experimental | Drug: Sacituzumab govitecanParticipants with metastatic/ recurrent well-differentiated or poorly differentiated radioactive iodine (RAI) refractory thyroid carcinoma. Each treatment cycle is 3 weeks. Treatment will be continued till disease progression, unacceptable toxicity or withdrawal of consent. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The participants (or legally acceptable representative if applicable) provide written consent for the trial.
- At least 21 years of age on the day of signing informed consent.
- Have histologically or cytologically confirmed diagnosis of advanced or unresectable salivary gland cancer or thyroid cancer, not amenable to local treatment.
- Have measurable disease based on RECIST 1.1.
- Patients with metastatic or recurrent unresectable advanced salivary gland cancers must have progressive disease within the previous 6 months and have seen at least 1 prior line of systemic treatment, unless the patients had contraindications to the systemic treatment considered standard of care or there was no standard of care for that particular salivary gland histological subtype.
Key exclusion criteria (22 listed)
- Has untreated brain metastases or leptomeningeal metastases.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
- Has received prior radiotherapy within 2 weeks of the start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known severe hypersensitivity reaction to Sacituzumab govitecan.
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 govitecanAlso: TrodelvyDay 1 and Day 8: Sacituzumab Govitecan will be administered at the dose of 10 mg/kg via intravenous infusion. | Drug | Cohort A, Cohort B |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 3 years
ORR is defined as the as the percentage of participants with a complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumours (RECIST) version 1.1.
4 secondary outcomes
Progression free survival (PFS)
Time frame: From date of treatment assignment until first documented progression or date of death, whichever occurs earlier, assessed up to 3 years
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: From date of informed consent till 90 days following the date of last dose of study treatment.
6-months Disease control rate (DCR)
Time frame: Up to 6 months after initiating study treatment.
Correlation of ORR with Trop-2 expression in tumour samples
Time frame: Up to 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 25 Jul 2025.
- Background: PubMed 20858281Cubas R, Zhang S, Li M, Chen C, Yao Q. Trop2 expression contributes to tumor pathogenesis by activating the ERK MAPK pathway. Mol Cancer. 2010 Sep 21;9:253. doi: 10.1186/1476-4598-9-253.
- Background: PubMed 24795243Schlumberger M, Brose M, Elisei R, Leboulleux S, Luster M, Pitoia F, Pacini F. Definition and management of radioactive iodine-refractory differentiated thyroid cancer. Lancet Diabetes Endocrinol. 2014 May;2(5):356-8. doi: 10.1016/S2213-8587(13)70215-8. Epub 2014 Jan 30. No abstract available.
- Background: PubMed 29543059Shulin JH, Aizhen J, Kuo SM, Tan WB, Ngiam KY, Parameswaran R. Rising incidence of thyroid cancer in Singapore not solely due to micropapillary subtype. Ann R Coll Surg Engl. 2018 Apr;100(4):295-300. doi: 10.1308/rcsann.2018.0004. Epub 2018 Mar 15.
- Background: PubMed 22006781Mahmood U, Koshy M, Goloubeva O, Suntharalingam M. Adjuvant radiation therapy for high-grade and/or locally advanced major salivary gland tumors. Arch Otolaryngol Head Neck Surg. 2011 Oct;137(10):1025-30. doi: 10.1001/archoto.2011.158.
- Background: PubMed 8879381Licitra L, Cavina R, Grandi C, Palma SD, Guzzo M, Demicheli R, Molinari R. Cisplatin, doxorubicin and cyclophosphamide in advanced salivary gland carcinoma. A phase II trial of 22 patients. Ann Oncol. 1996 Aug;7(6):640-2. doi: 10.1093/oxfordjournals.annonc.a010684.
- Background: PubMed 28709407Guan H, Guo Z, Liang W, Li H, Wei G, Xu L, Xiao H, Li Y. Trop2 enhances invasion of thyroid cancer by inducing MMP2 through ERK and JNK pathways. BMC Cancer. 2017 Jul 14;17(1):486. doi: 10.1186/s12885-017-3475-2.
- Background: PubMed 37633306Rugo 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.
- Background: PubMed 38843511Paz-Ares LG, Juan-Vidal O, Mountzios GS, Felip E, Reinmuth N, de Marinis F, Girard N, Patel VM, Takahama T, Owen SP, Reznick DM, Badin FB, Cicin I, Mekan S, Patel R, Zhang E, Karumanchi D, Garassino MC. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733. Epub 2024 May 31.
- Individual participant dataSharing planned: No. Explain why IPD will not or might not be shared.
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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.
Wan Qin Dr Chong, MD principal investigator
National University Hospital, Singapore
1 site 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 govitecan in people with Salivary Gland Cancer and Thyroid Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 9 inclusion and 22 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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 Wan Qin Dr Chong, MD (+65 6908 2222, wan_qin_chong@nuhs.edu.sg), 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: Up to 3 years). 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 NCT06923826, which also lists 8 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 25 Jul 2025.