Sacituzumab Tirumotecan in Recurrent/Metastatic Adenoid Cystic Carcinoma and Papillary Thyroid Carcinoma (STRAP)

NCT07521670 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ATLAS2501 NCCH2413/MK016
• Study Type: interventional
• Target: 68
• Locations: 4 countries
• Sites: 7

Brief Summary

This is an open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab Tirumotecan (sac-TMT) monotherapy in patients with recurrent or metastatic adenoid cystic carcinoma (ACC) of salivary gland origin and papillary thyroid carcinoma (PTC). A total of 68 patients will be enrolled over in 18-month period, with 34 patients in Cohort A (ACC) and 34 in Cohort B (PTC). All participants will receive sac-TMT at a dose of 4 mg/kg administered intravenously on Days 1 and 15 of each 28-day cycle. The primary endpoint is the objective response rate (ORR), defined as the proportion of patients achieving a complete or partial response as assessed by the site investigators. Secondary endpoints include progression-free survival, overall survival, disease control rate, safety and tolerability, dose intensity, and relative dose intensity.

Conditions

Recurrent Adenoid Cystic Carcinoma; Adenoid Cystic Carcinoma Metastatic; Papillary Thyroid Carcinoma

Keywords

Sacituzumab Tirumotecan; Recurrent; Metastatic; Adenoid Cystic Carcinoma; Papillary Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) as assessed by the investigator (site assessment).

  The objective response rate is defined as the proportion of patients in the full analysis set whose best overall response is a complete response (CR) or partial response (PR) assessed by the investigator (site assessment).

  Every 8 weeks until 48 weeks, then every 12 weeks after 49 weeks after the initiation of protocol treatments, until disease progression, initiation of post-study treatment, or study completion, approximately 2.5 years.

Secondary Outcomes (8)

• Progression-free survival.

  From date of enrollment until disease progression or death, whichever occurs first, through study completion, approximately 2.5 years.

• Overall survival.

  From date of enrollment until death, through study completion, approximately 2.5 years.

• Disease control rate.

  From date of enrollment until disease progression, initiation of post-study treatment, or study completion, approximately 2.5 years.

• Proportion of patients with adverse events.

  From date of first dose of study drug until 30 days after the last dose of study drug or initiation of post-study treatment, whichever comes first. Assessed up to approximately 2.5 years.

• Proportion of patients with adverse drug reactions.

  From date of first dose of study drug until 30 days after the last dose of study drug or initiation of post-study treatment, whichever occurs first. Assessed up to approximately 2.5 years.

Study Arms (1)

Sacituzumab Tirumotecan

EXPERIMENTAL

Drug: Sacituzumab Tirumotecan

Interventions

Sacituzumab Tirumotecan DRUG

Sacituzumab Tirumotecan 4 mg/kg is administered on Days 1 and 15 of each 28-day (4 week) cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation. The duration of Sacituzumab Tirumotecan infusions should be 90 minutes (±15 minutes) and infusion-related reactions will be monitored. The infusion duration may be adjusted to be longer than 105 minutes at the discretion of the investigator, but the infusion of Sacituzumab Tirumotecan needs to be completed within the timeframe specified in the Pharmacy Manual. After at least 4 administrations and in the absence of either infusion-related reactions or hypersensitivity reactions, the infusion may be shortened at the discretion of the investigator but cannot be shorter than 60 minutes.

Sacituzumab Tirumotecan

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Common Eligibility Criteria for Cohorts A and B
• Unresectable locally advanced or recurrent/metastatic adenoid cystic carcinoma or papillary thyroid carcinoma.
• Trophoblast cell-surface antigen 2 (TROP2) expression testing by immunohistochemistry or other methods is not required for enrollment. Provision of archival tumour tissue (where available) will be requested to support retrospective analysis. Waiver for tissue submission may be granted by the Steering Committee on a case-by-case basis if archival tissue is unavailable or insufficient for analysis.
• Age ≥18 years at the time of enrollment (≥21 years in Singapore)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• At least one target lesion \*identified on contrast-enhanced CT (head, neck, chest, abdomen, pelvis with ≤5 mm slice thickness) performed within 14 days prior to enrollment (same day of the week within 14 days is acceptable; this applies similarly to other time-based criteria below).
• \* A non-lymph node lesion with a longest diameter of ≥10 mm or a lymph node lesion with a short axis of ≥15 mm
• No prior treatment with Trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugates or antibody-drug conjugates containing anti-topoisomerase I agents.
• Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or pre-treatment baseline level (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.
• No administration of anticancer therapies (e.g., chemotherapy, targeted therapy, immunotherapy) within 13 days prior to enrollment.
• No major surgery under general anesthesia within 27 days prior to enrollment.
• No radiotherapy (including Gamma Knife or CyberKnife) within 13 days prior to enrollment. Thirteen days or fewer of palliative radiotherapy for non-CNS disease prior to enrollment is permitted. The last radiotherapy treatment must have been performed at least 7 days before enrollment.Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
• Laboratory values within the following criteria based on testing within 14 days prior to enrollment.
• Neutrophil count≥1,500/mm3
• Platelet count≥10x10\^4/mm3

You may not qualify if:

• Active central nervous system (CNS) metastases - including brain metastases, carcinomatous (leptomeningeal) meningitis, or symptomatic spinal metastases that require radiotherapy or surgical intervention. However, patients with previously treated brain metastases may be enrolled if imaging performed at screening shows radiographic stability for at least 28 days with no evidence of progression, they are clinically stable, and they have not required steroid therapy for at least 14 days before enrollment.
• Clinically significant pericardial effusion, pleural effusion, or ascites requiring treatment.
• Has a current and past history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, prior treatment history with cardiotoxic agents and/or other serious cardiovascular and cerebrovascular diseases within 6 months before enrollment.
• Received a live or live-attenuated vaccine within 30 days before enrollment. Administration of inactivated vaccines are allowed.
• Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.
• Note: A list of strong inducers/inhibitors of CYP3A4 can be found at the following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer/inhibitor of CYP3A4.
• Is currently participating in another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.
• Has received an investigational agent or has used an investigational device within 28 days before enrollment.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.
• Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \<10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
• 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 treating investigator.
• Severe hypersensitivity (Grades ≥3) to study intervention, any of their excipients, and/or to another biologic therapy.
• Note: Participants who underwent major surgery must have adequately recovered from toxicity and/or complications from the surgery before starting study intervention.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Merck Sharp & Dohme LLC: collaborator
• National Cancer Center, Japan: collaborator

Study Sites (7)

National Cancer Center Hospital

Tokyo, Japan

Location

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Location

University of Malaya Medical Center

Kuala Lumpur, Malaysia

Location

National Cancer Centre Singapore

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

National Cancer Center Korea

Gyeonggi-do, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic; Thyroid Cancer, Papillary; Recurrence; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma, Papillary; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Darren Wan-Teck Lim, MBBS (S'pore), MRCP (UK), FAMS

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darren Wan-Teck Lim, MBBS (S'pore), MRCP (UK), FAMS

CONTACT

+65 6436 8000; darren.lim.w.t@singhealth.com.sg

Yoshitaka Honma, M.D., Ph.D.

CONTACT

+81 335475201; yohonma@ncc.go.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2); SG (2); JP (1); KR (2)