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Sacituzumab Govitecan and Q901 in Advanced TNBC

NCT07788222 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-08-26

No results posted yet for this study

Summary

This is a multicenter, open-label, single-arm phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab govitecan (SG) in combination with Q901 in patients with advanced (metastatic/recurrent/unresectable) triple-negative breast cancer (TNBC) whose disease has progressed following prior therapy, in the third-line treatment setting.

Subjects enrolled in this trial must be patients diagnosed with advanced TNBC who have received at least 2 prior lines of systemic anticancer therapy, which may include chemotherapy, targeted therapy, or immunotherapy. However, for subjects who received adjuvant/neoadjuvant chemotherapy for resectable-stage breast cancer and relapsed within 12 months after completion of the last chemotherapy, the adjuvant/neoadjuvant chemotherapy is counted as one line of therapy. There are no restrictions on the type or sequence of prior therapies, but all subjects must have measurable disease per RECIST 1.1 criteria at the time of enrollment.

Subjects will be assigned to a single treatment arm and will receive the following combination regimen:

Sacituzumab govitecan (SG): 10 mg/kg administered intravenously on Day 1 and Day 8 of each 21-day cycle Q901: 126 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle

Each treatment cycle is defined as 21 days, and study drug administration will continue until disease progression, unacceptable toxicity, discontinuation of treatment at the discretion of the investigator or subject, withdrawal of consent, or death.

Prior to full-scale phase II enrollment, this trial includes a safety run-in phase to evaluate the initial safety and dose appropriateness of the SG plus Q901 combination.

In the safety run-in phase, a small number of subjects will receive the combination regimen to assess the occurrence of dose-limiting toxicities (DLTs); if DLTs are observed, dose de-escalation of Q901 will be considered.

Based on the results of the safety run-in, the final combination dose to be used in the phase II portion will be determined, after which expansion enrollment will proceed.

The target number of subjects to be enrolled in this trial is a maximum of 6-18 in the safety run-in phase and 30 in the phase II portion, for a total maximum enrollment of 48 subjects across the entire trial.

The primary endpoint is objective response rate per RECIST v1.1; secondary endpoints include progression-free survival, overall survival, duration of response, disease control rate, safety, and quality of life.

Conditions

  • Triple Negative Breast Neoplasms

Interventions

DRUG

Sacituzumab govitecan and Q901

Sacituzumab govitecan 10 mg/kg is administered intravenously on Days 1 and 8 of every 21-day cycle. Q901 126 mg/m² is administered intravenously over 60 minutes on Days 1 and 8 of every 21-day cycle. Both agents are given in combination until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-05-31
Completion
2028-06-30

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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 NCT07788222 on ClinicalTrials.gov