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

NCT07521670 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

DRUG

Sacituzumab Tirumotecan

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.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • National Cancer Center, Japan

    collaborator OTHER_GOV

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Darren Wan-Teck Lim, MBBS (S'pore), MRCP (UK), FAMS · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • Japan
  • Malaysia
  • Singapore
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07521670 on ClinicalTrials.gov