Sacituzumab Govitecan and Q901 in Advanced TNBC
ConditionTriple Negative Breast Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically or cytologically confirmed triple-negative breast cancer (TNBC) who have received at least 2 prior lines of systemic anticancer therapy for recurrent, metastatic, or unresectable disease. TNBC is defined as estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative status.
IHC 0 or 1+ without in-situ hybridization (ISH) results, or
IHC 2+ with negative ISH (single-probe ISH average HER2 gene copy number <4 signals/cell, or dual-probe ISH HER2/CEP17 ratio <2.0 with average HER2 gene copy number <4 signals/cell), or
Negative ISH without IHC results.
Disqualifiers
Prior treatment with a TROP2-targeted antibody-drug conjugate, or a history of receiving a selective CDK7 inhibitor including Q901.
Severe cardiac disease (e.g., uncontrolled hypertension, congestive heart failure [NYHA class ≥2], ventricular arrhythmia, active ischemic heart disease, or history of myocardial infarction within the past 1 year).
Current active hepatic or biliary disease (Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease may be excluded from this criterion at the investigator's discretion).
Patients with a clinically significant, uncontrolled medical condition that limits the ability to comply with study procedures, or other medical conditions that place the patient at an unacceptable risk of toxicity.
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab govitecan and Q901
DrugSacituzumab 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.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Sacituzumab Govitecan plus Q901Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate, ORR by RECIST v1.1
Objective response rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) as best overall response per RECIST v1.1. Tumor response is assessed by CT or MRI every 8 weeks, and responses are confirmed by imaging performed at least 4 weeks apart
Time frame
Up to 24 monthsSecondary outcomes
1
Progression-Free Survival (PFS)
Time from the first dose (Cycle 1 Day 1) to the first occurrence of disease progression per RECIST v1.1 or death from any cause, whichever comes first.
Time frame
Up to 24 months2
overall survival (OS)
Time from the first dose to death from any cause.
Time frame
Up to 24 months3
Duration of Response (DoR)
Time from the first documented objective response (CR or PR) to disease progression per RECIST v1.1 or death, whichever comes first; evaluated only in participants with a confirmed objective response.
Time frame
Up to 24 months4
Disease Control Rate (DCR)
Proportion of participants achieving complete response, partial response, or stable disease as best overall response per RECIST v1.1.
Time frame
Up to 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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