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Sac-TMT in Vaginal and Vulvar Cancers

NCT07804966 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-09-04

No results posted yet for this study

Summary

The ARCANA trial (LACOG 1724) is a single-arm, non-randomized, multi-center, parallel, two-cohort Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT, MK-2870) as a second-line or subsequent treatment in patients with advanced or metastatic vaginal and vulvar squamous cell carcinomas. Given the rarity of these cancers and the lack of standard second-line therapies, this study explores sac-TMT, a novel TROP-2-directed antibody-drug conjugate (ADC). TROP-2 is highly expressed in both vulvar and vaginal squamous cell carcinomas, making it a promising therapeutic target.

Conditions

  • Vaginal Squamous Cell Carcinoma
  • Vulvar Squamous Cell Carcinoma

Interventions

DRUG

Sacituzumab Tirumotecan (sac-TMT)

Sacituzumab tirumotecan is a TROP-2-directed antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase 1 inhibitor payload (KL610023). It will be administered intravenously at a dose of $4\\text{ mg/kg}$ on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity, or up to a maximum duration of approximately 2 years.

Sponsors & Collaborators

  • Latin American Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Fernando Cotait Maluf · Hospital Israelita Albert Einstein

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2030-03-31
Completion
2032-01-31

Countries

  • Brazil

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 NCT07804966 on ClinicalTrials.gov