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

NCT06923826 | Recruiting Phase 2

• 2 other identifiers: ECOS Ref. 2024-3605CO-US-979-7131
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the drug, sacituzumab govitecan, works to treat:

• 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

Keywords

salivary gland cancer; Sacituzumab govitecan; thyroid cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 years

Secondary Outcomes (4)

• Progression free survival (PFS)

  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)

  From date of informed consent till 90 days following the date of last dose of study treatment.

• 6-months Disease control rate (DCR)

  Up to 6 months after initiating study treatment.

• Correlation of ORR with Trop-2 expression in tumour samples

  Up to 3 years

Study Arms (2)

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

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.

Drug: Sacituzumab govitecan

Interventions

Sacituzumab govitecan DRUG

Day 1 and Day 8: Sacituzumab Govitecan will be administered at the dose of 10 mg/kg via intravenous infusion.

Also known as: Trodelvy

Cohort A; Cohort B

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Gilead Sciences: collaborator

Study Sites (1)

National University Cancer Institute Singapore

Singapore, 119074, Singapore

RECRUITING

Related Publications (8)

• 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.

  PMID: 20858281 BACKGROUND

• Schlumberger 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.

  PMID: 24795243 BACKGROUND

• Shulin 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.

  PMID: 29543059 BACKGROUND

• Mahmood 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.

  PMID: 22006781 BACKGROUND

• Licitra 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.

  PMID: 8879381 BACKGROUND

• Guan 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.

  PMID: 28709407 BACKGROUND

• 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.

  PMID: 37633306 BACKGROUND

• Paz-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.

  PMID: 38843511 BACKGROUND

MeSH Terms

Conditions

Salivary Gland Neoplasms; Thyroid Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Wan Qin Dr Chong, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan Qin Dr Chong, MD

CONTACT

+65 6908 2222; wan_qin_chong@nuhs.edu.sg

Boon Cher Prof Goh, MD

CONTACT

+65 6908 2222; phcgbc@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 11, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 25, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)