Neoadjuvant TherapyPhase 2NCT07054242
A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC)
A Phase 2 study testing Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab in people with Neoadjuvant Therapy and Stage II to III (T1cN1-2 or T2-4N0-2) TNBC Breast Cancer, run by Yantai Yuhuangding Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoadjuvant Therapy, Stage II to III (T1cN1-2 or T2-4N0-2) TNBC Breast Cancer
- What is being tested?
- Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 20Show fewer
- 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
- TSH within normal range (or normal FT3/FT4 if TSH abnormal)
- Normal cardiac enzymes (isolated abnormalities allowed if clinically insignificant)
- No prior anti-cancer therapy for current diagnosis.
- For women of childbearing potential and men with WOCBP partners: agreement to use effective contraception from screening until 6 months post-treatment.
- Willing and able to comply with study procedures and provide written informed consent.
Who cannot join
- 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).
Show all 28Show fewer
- 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
- Prior pneumonectomy
- Active autoimmune disease requiring systemic treatment (past 2 years), except:
- Hormone replacement therapy
- Physiologic corticosteroid replacement
- Active infection requiring systemic therapy within 14 days prior to initiation.
- Uncontrolled comorbidities that may:
- Compromise patient safety
- Interfere with study completion
- Any condition that in the investigator's judgment may:
- Affect study drug evaluation
- Compromise safety assessments
- Interfere with data interpretation
- Otherwise contraindicate participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Breast Surgery, Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Guangdong Qiao, 0535-6691999-81603, qiaogddxy@163.com
Yalun Li
About this study
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.
- Being tested
- Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab
- Keywords
- SKB264, Pembrolizumab, TNBC, Neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Tirumotecan (SKB264) plus PembrolizumabDrug
Also called SKB264 also named sac-TMT or MK2870
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)
| Study group | Role | What they receive |
|---|---|---|
| SKB264 plus Pembrolizumab | Experimental | Not described Receives: Drug: Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR, defined as the proportion of subjects with Complete Response (CR) and Partial Response (PR) among the total subjects.
Measured: 8 weeks and 18 weeks
Event-Free Survival (EFS)
EFS, defined as the time from the start of treatment to the first occurrence of any of the following events: disease progression that precludes surgical treatment, local or distant recurrence, or death from any cause.
Measured: up to 36 months
Overall Survival (OS)
OS, defined as the time from the start of treatment to the death of the subject from any cause.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Oct 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Guangdong Qiao, Yantai Yuhuangding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054242
- Sponsor's protocol ID
- NIKORA
- Status last verified
- Sep 2025
- First submitted
- 25 May 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT07054242
- Acronym / sponsor ID
- NIKORA
- Keywords
- SKB264, Pembrolizumab, TNBC, Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Yantai Yuhuangding HospitalUniversity, hospital or other
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKB264 plus Pembrolizumab | Experimental | Drug: Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically or cytologically confirmed stage II-III (T1cN1-2 or T2-4N0-2) triple-negative breast cancer (TNBC), defined as:
- 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:
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Tirumotecan (SKB264) plus PembrolizumabAlso: SKB264 also named sac-TMT or MK2870SKB264 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) | Drug | SKB264 plus Pembrolizumab |
Primary outcome
Pathological complete response rate (pCR: ypT0/is, ypN0)
Time frame: 18 weeks
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.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 8 weeks and 18 weeks
Event-Free Survival (EFS)
Time frame: up to 36 months
Overall Survival (OS)
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Neoadjuvant Therapy
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab in people with Neoadjuvant Therapy and Stage II to III (T1cN1-2 or T2-4N0-2) TNBC Breast Cancer, run by Yantai Yuhuangding Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guangdong Qiao (China: 0535-6691999-81603, qiaogddxy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR: ypT0/is, ypN0) (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.