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A Phase II, Investigator-Initiated Exploratory Study of Sacituzumab Tirumotecan for Previously Treated Unresectable Thymic Carcinomas

NCT07750353 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-08-06

No results posted yet for this study

Summary

This is a non-randomized, open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of sacituzumab tirumotecan (hereafter referred to as sac-TMT) in patients with unresectable thymic carcinoma who have a history of platinum-based combination chemotherapy.

Conditions

  • Unresectable Thymic Carcinoma

Interventions

DRUG

Sacituzumab Tirumotecan (Sac-TMT)

Sacituzumab tirumotecan at 4 mg/kg is administered intravenously on Day 1 and Day 15 of each 28-day cycle and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. The maximum exposure period for sacituzumab tirumotecan is 78 cycles (approximately 3 years).

Sponsors & Collaborators

  • National Cancer Center, Japan

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-01
Primary Completion
2029-12-31
Completion
2030-06-30

Countries

  • Japan

Study Locations

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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 NCT07750353 on ClinicalTrials.gov