A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC)

NCT07054242 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NIKORA
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single center, phase II study to enroll participants with stage II or III TNBC who have not previously undergone systemic therapy. The primary endpoint is pCR in the ITT population. The study aims to enroll 52 participants. Eligible participants will receive a combination therapy of SKB264 and Pembrolizumab. Experimental arm: SKB264 will be administered intravenously (IV) at a dose of 4 mg/kg every two weeks (Q2W); Pembrolizumab will be administered intravenously at a dose of 200mg every three weeks (Q3W) All enrolled participants will initially receive SKB264 plus Pembrolizumab for 8 weeks. Based on early imaging and biopsy assessment, patients who deemed as responders continue to receive combined drug therapy for 10 weeks, followed by surgical treatment. Patients who assessed as non-responders will be treated at the discretion of the physician. Participants will undergo regular tumor assessments based on RECIST 1.1 criteria. Imaging assessments will be conducted every 9 weeks (±1 week) for the first 18 weeks following treatment initiation, and every 12 weeks (±1 week) thereafter, until confirmed disease progression, initiation of a new antitumor treatment, withdrawal of consent, loss to follow-up, death, or study end, whichever occurs first. After termination of the study treatment, participants must complete the EOT visit and a safety follow-up, and undergo survival visits every 3 months (±14 days) post the last dose to collect information on survival, new antitumor treatments received.

Conditions

Neoadjuvant Therapy; Stage II to III (T1cN1-2 or T2-4N0-2) TNBC Breast Cancer

Keywords

SKB264; Pembrolizumab; TNBC; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR: ypT0/is, ypN0)

  pCR: defined as the absence of histological evidence of malignant tumor in the primary breast cancer and metastatic regional lymph nodes, or the presence of only carcinoma in situ components.

  18 weeks

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  8 weeks and 18 weeks

• Event-Free Survival (EFS)

  up to 36 months

• Overall Survival (OS)

  up to 36 months

Other Outcomes (1)

• TROP2; PD-L1; HER2; Ki67

  up to 22 weeks

Study Arms (1)

SKB264 plus Pembrolizumab

EXPERIMENTAL

Drug: Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab

Interventions

Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab DRUG

SKB264 will be administered intravenously (IV) at a dose of 4 mg/kg every two weeks (Q2W); Pembrolizumab will be administered intravenously at a dose of 200mg every three weeks (Q3W)

Also known as: SKB264 also named sac-TMT or MK2870

SKB264 plus Pembrolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed stage II-III (T1cN1-2 or T2-4N0-2) triple-negative breast cancer (TNBC), defined as:
• Immunohistochemistry (IHC) showing ER and PR \<1%
• HER2-negative per 2028 ASCO-CAP guidelines (IHC 0/1+ or IHC 2+/ISH-)
• Available tumor tissue sample for biomarker analysis.
• At least one measurable lesion as per RECIST 1.1 criteria.
• ECOG performance status 0-1.
• Adequate organ function as evidenced by:
• Absolute neutrophil count ≥1.5×10⁹/L (no G-CSF support within 14 days)
• Platelets ≥100×10⁹/L (no transfusion within 14 days)
• Hemoglobin \>9 g/dL (no transfusion/ESA within 14 days)
• Total bilirubin ≤1.5×ULN
• AST/ALT ≤1.5×ULN
• Alkaline phosphatase ≤2.5×ULN
• Serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault)
• INR/PT ≤1.5×ULN

You may not qualify if:

• LVEF \<50% by ECHO/MUGA or significant cardiac disease (NYHA Class III/IV).
• Prior chemotherapy, targeted therapy, or radiotherapy for current breast cancer.
• Previous treatment with immune checkpoint inhibitors (anti-PD-1/L1, anti-CTLA-4) or T-cell targeting therapies.
• Prior Trop-2 directed therapy or topoisomerase I inhibitor treatment.
• Other malignancies within 5 years (except adequately treated CIS of cervix, BCC, or cutaneous SCC).
• Severe ocular surface disease (dry eye syndrome, meibomian gland dysfunction, or corneal disorders impairing healing).
• Known hypersensitivity to study drug components.
• History of immunodeficiency disorders or organ transplantation.
• Current or history of:
• Steroid-requiring interstitial lung disease/pneumoniti Unresolved ILD/pneumonitis on screening imaging
• Clinically significant pulmonary conditions including:
• Recent pulmonary embolism (≤3 months)
• Severe asthma/COPD/restrictive lung disease
• Pleural effusion requiring intervention
• Connective tissue disease with pulmonary involvement

Sponsors & Collaborators

• Yantai Yuhuangding Hospital: lead
• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Department of Breast Surgery, Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

Central Study Contacts

Guangdong Qiao

CONTACT

China: 0535-6691999-81603; qiaogddxy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Breast Surgery, Chief Physician

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: July 8, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)