Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC) (TROP2)

July 22, 2025 updated by: National University Hospital, Singapore

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:

  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. 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Cancer Institute Singapore
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wan Qin Dr Chong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The participants (or legally acceptable representative if applicable) provide written consent for the trial.
  2. At least 21 years of age on the day of signing informed consent.
  3. Have histologically or cytologically confirmed diagnosis of advanced or unresectable salivary gland cancer or thyroid cancer, not amenable to local treatment.
  4. Have measurable disease based on RECIST 1.1.
  5. 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.
  6. 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.
  7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  8. Have an adequate organ function. Specimens must be collected within 10 days prior to the start of study treatment.
  9. Provision of blood and tumour tissue samples (newly obtained biopsy if clinically feasible or archival specimen) to support exploratory biomarker analysis.

Exclusion Criteria:

  1. Has untreated brain metastases or leptomeningeal metastases.
  2. 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.
  3. 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.
  4. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  5. Known severe hypersensitivity reaction to Sacituzumab govitecan.
  6. Has an active infection requiring systemic treatment. This includes TB (Bacillus Tuberculosis).
  7. 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.
  8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

  9. Recent cardiovascular thromboembolic event, such as the following:

    1. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 4 weeks before enrolment
    2. Symptomatic pulmonary embolism ≤ 4 weeks before enrolment
    3. Any history of acute myocardial infarction ≤ 6 months before enrolment
    4. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤ 6 months before enrolment
    5. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before enrolment
    6. Any history of cerebrovascular accident ≤ 6 months before enrolment
  10. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial

  11. 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.

  12. 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:

    1. 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.
    2. 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.
  13. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A

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
Drug: Sacituzumab govitecan
Day 1 and Day 8: Sacituzumab Govitecan will be administered at the dose of 10 mg/kg via intravenous infusion.
Other Names:
  • Trodelvy
Experimental: Cohort B
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.
Drug: Sacituzumab govitecan
Day 1 and Day 8: Sacituzumab Govitecan will be administered at the dose of 10 mg/kg via intravenous infusion.
Other Names:
  • Trodelvy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
PFS is defined as the time from treatment assignment to disease progression or death, whichever occurs first
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.
The frequency and outcome of TRAEs as assessed and graded according to the CTCAE version 5.0.
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.
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.
Up to 6 months after initiating study treatment.
Correlation of ORR with Trop-2 expression in tumour samples
Time Frame: Up to 3 years
Relationship between ORR and Trop-2 expression levels measured in tumour samples.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Wan Qin Dr Chong, MD, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECOS Ref. 2024-3605
  • CO-US-979-7131 (Other Identifier: Gilead)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Explain why IPD will not or might not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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