Sacituzumab Govitecan and Q901 in Advanced TNBC

NCT07788222 | Not Yet Recruiting Phase 2

• 1 other identifier: 4-2026-0705
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Triple-Negative Breast Cancer (TNBC); Sacituzumab Govitecan (SG); Q901; CDK7 inhibitor; Antibody-Drug Conjugate (ADC)

Outcome Measures

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

  Up to 24 months

Secondary Outcomes (8)

• Progression-Free Survival (PFS)

  Up to 24 months

• overall survival (OS)

  Up to 24 months

• Duration of Response (DoR)

  Up to 24 months

• Disease Control Rate (DCR)

  Up to 24 months

• Adverse Events (AE)

  Up to 24 months

Study Arms (1)

Sacituzumab Govitecan plus Q901

EXPERIMENTAL

Participants receive sacituzumab govitecan 10 mg/kg (intravenous) and Q901 126 mg/m² (intravenous, over 60 minutes) on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Drug: Sacituzumab govitecan and Q901

Interventions

Sacituzumab govitecan and Q901 DRUG

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.

Also known as: Sacituzumab govitecan: Trodelvy (SG). Q901: selective CDK7 inhibitor.

Sacituzumab Govitecan plus Q901

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ER-negative and PR-negative are defined as nuclear staining in \<1% of cells by immunohistochemistry (IHC).
• HER2-negative is defined by any of the following:
• 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.
• Male or female patients aged ≥19 years.
• Patients who have received at least 2 prior lines of systemic anticancer therapy for recurrent, metastatic, or unresectable TNBC.
• Prior therapy may include chemotherapy, immunotherapy, or targeted therapy. There is no restriction on the type or sequence of prior therapies (however, prior treatment with a taxane-based regimen is required).
• \*Patients who received adjuvant/neoadjuvant therapy for surgically resectable breast cancer and relapsed within 12 months after completion of the last chemotherapy are considered to have received 1 line of chemotherapy.
• Patients who have provided written informed consent prior to any study-specific procedures.
• Patients with at least 1 measurable lesion per RECIST 1.1 on baseline CT.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients with adequate organ function as defined below. Transfusion or growth factor support is not permitted within 14 days prior to screening laboratory tests.
• A. Absolute Neutrophil Count (ANC) ≥ 1,500 cells/mm³ B. Platelets ≥ 100,000/mm³ C. Hemoglobin ≥ 9.0 g/dL D. Total bilirubin ≤ 1.5 × ULN E. AST (SGOT) ≤ 2.5 × ULN (≤ 5.0 × ULN if liver metastases are present) F. ALT (SGPT) ≤ 2.5 × ULN (≤ 5.0 × ULN if liver metastases are present) G. Creatinine clearance ≥ 60 mL/min calculated using the Cockcroft-Gault equation, or serum creatinine ≤ 1.5 × ULN

You may not qualify if:

• 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.
• Patients with symptomatic CNS metastases, or CNS metastases requiring local treatment (e.g., radiotherapy or surgery). Patients previously treated for brain metastases must be clinically and radiologically stable (no evidence of disease progression and all neurological symptoms returned to baseline from ≥4 weeks after treatment until study enrollment; no evidence of new or progressive brain metastases) and must not have received steroid therapy exceeding physiological doses (\>10 mg prednisolone/day) for at least 2 weeks prior to administration of the study drug. Regardless of the above conditions, subjects with leptomeningeal carcinomatosis are not permitted.
• Concomitant use of known strong CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin, and nelfinavir.
• Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients who have completed curative therapy for HCV are eligible. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable at the time of enrollment.
• Patients with significantly impaired mental status, or psychological, familial, sociological, or geographical conditions that impede understanding of the study or potentially interfere with compliance with the study protocol and follow-up schedule.
• Patients diagnosed with another malignancy within 5 years. Exceptions are non-melanoma skin cancer treated with curative intent, in-situ disease treated with curative intent, thyroid cancer, or cervical intraepithelial carcinoma.
• Patients who are pregnant or breastfeeding, or who plan to conceive during the scheduled study period from the screening visit until 7 months after the last dose of study drug.
• Patients who received a live or live-attenuated vaccine within 30 days prior to the scheduled first dose of the study drug.
• Unresolved active systemic infection.
• In addition to the above criteria, the investigator may exclude a subject from the study if the subject is judged to have conditions that may compromise subject safety or the scientific validity of the study.

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Joohyuk Sohn, Professor

CONTACT

82-2-228-8135; oncosohn@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm study in which all participants receive the same combination regimen (sacituzumab govitecan plus Q901). A safety run-in phase precedes Phase II enrollment.

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08