OncoMatch/Clinical Trials/NCT07371208

Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer

Is NCT07371208 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies SKB264 for breast cancer.

Phase 2RecruitingShanghai Jiao Tong University School of MedicineNCT07371208Data as of May 2026

Treatment: SKB264 — This study is a multicenter phase II trial planning to enroll 40 patients with primary triple-negative breast cancer (tumor size ≥2 cm, clinical lymph node stage cN0-3, M0). Participants will receive the combination therapy of Sac-TMT and KL-A167 during the neoadjuvant treatment phase. The study aims to evaluate the efficacy and safety of Sac-TMT combined with KL-A167 as neoadjuvant treatment for triple-negative breast cancer.

Check if I qualify

Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 low expression (IHC <10%)

TNBC Definition: Immunohistochemistry (IHC) showing ER and PR <10%

Required: PR (PGR) low expression (IHC <10%)

TNBC Definition: Immunohistochemistry (IHC) showing ER and PR <10%

Required: HER2 (ERBB2) negative (IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH))

HER2-negative: IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH)

Disease stage

Required: Stage CN0, CN1, CN2, CN3

Excluded: Stage DISTANT METASTASIS

meeting the criteria of tumor size ≥2 cm, clinical lymph node stage cN0 to cN3, and M0 (no distant metastasis)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: chemotherapy

Any prior chemotherapy ... for the currently diagnosed breast cancer prior to enrollment

Cannot have received: targeted therapy

Any prior ... targeted therapy ... for the currently diagnosed breast cancer prior to enrollment

Cannot have received: radiation therapy

Any prior ... radiotherapy for the currently diagnosed breast cancer prior to enrollment

Cannot have received: anti-PD-1 therapy

Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Cannot have received: TROP2-targeted therapy

Previous treatment with any TROP2-targeted therapy

Cannot have received: topoisomerase I inhibitor

Previous treatment with any ... topoisomerase I inhibitor

Lab requirements

Blood counts

ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 80 × 10⁹/L; Hemoglobin ≥ 10 g/dL

Kidney function

Creatinine clearance (Ccr) ≥ 60 mL/min (Cockcroft-Gault)

Liver function

AST, ALT, and ALP ≤ 2.5 × ULN; TBIL ≤ 1.5 × ULN

Cardiac function

LVEF ≥ 55% by ECHO or MUGA

Adequate Organ and Bone Marrow Function: Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 80 × 10⁹/L; Hemoglobin ≥ 10 g/dL. Liver Function: AST, ALT, and ALP ≤ 2.5 × ULN; TBIL ≤ 1.5 × ULN. Renal Function: Creatinine clearance (Ccr) ≥ 60 mL/min (Cockcroft-Gault). Coagulation: INR, APTT, and PT ≤ 1.5 × ULN. Cardiac Function: LVEF ≥ 55% as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify