Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel/Carboplatin Neoadjuvant for TNBC

A Prospective, Multicenter, Single-Arm Study of AK112 in Combination With Albumin-Bound Paclitaxel and Carboplatin as Neoadjuvant Treatment for Triple-Negative Breast Cancer

This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). The study seeks to address the pathological complete response (pCR) rate, objective response rate (ORR), breast conservation rate, and invasive disease-free survival (iDFS) following treatment with AK112 combined with albumin-bound paclitaxel and carboplatin in early or locally advanced TNBC.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer - Female
• Intervention / Treatment: Drug: AK112, Carboplatin, Paxlitaxel

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ting Luo; Phone Number: 86 +18980606230; Email: luoting@wchscu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntary Participation and Informed Consent: The participant voluntarily agrees to join this clinical trial, signs a written informed consent form, understands the study, and is willing to comply with all trial procedures.
2. Eligibility by Age and Gender: Female participants aged ≥18 years and ≤75 years on the day of signing the informed consent form.
3. Pathological Confirmation of Disease: Histopathologically confirmed diagnosis of T1-4N0-3M0 (except for T1N0M0) triple-negative invasive breast cancer, defined as negative for estrogen receptor (ER) and progesterone receptor (PgR) (immunohistochemistry: ER, PR < 1%), and human epidermal growth factor receptor 2 (HER2) (immunohistochemistry HER2 "0~1+"; or immunohistochemistry HER2 "2+" with no amplification on HER2 FISH gene testing).
4. Measurable Lesion: At least one lesion measurable according to RECIST v1.1 criteria. Participants diagnosed at an external institution agree to provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded [FFPE] tissue blocks or at least 25 unstained tumor tissue slides) for pathology review.
5. Planned Surgical Treatment: Participants are scheduled to undergo definitive surgical resection of breast cancer, including either breast-conserving surgery or mastectomy, along with sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND), and are planned to receive neoadjuvant chemotherapy.

Exclusion Criteria:

1. Prior Anti-Cancer Treatments.
2. Received systemic anti-cancer treatment, including chemotherapy, radiotherapy, immunotherapy, targeted therapy (within 2 weeks for small molecule targeted therapies), or biological agent treatment within 4 weeks before enrollment.
3. Received palliative local treatments within 2 weeks before enrollment.
4. Received systemic non-specific immune modulatory treatments (e.g., interleukins, interferons, thymopeptides) within 2 weeks before enrollment.
5. Received traditional Chinese medicine or Chinese patent medicines with anti-cancer indications within 2 weeks before enrollment.
6. Prior PD-1/PD-L1 Treatment.
7. Previously received treatment with PD-1 inhibitors or PD-L1 inhibitors.
8. Concurrent Participation in Other Clinical Studies.
9. Currently participating in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study.
10. History of Other Malignancies:

(1) Has a history of other malignant tumors within 5 years prior to enrollment or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and thyroid cancer.

(2) Active Autoimmune Diseases: Has active autoimmune diseases that required systemic treatment (such as corticosteroids) within 2 years before enrollment, or has autoimmune diseases that the investigator judges may recur or require planned treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK112 combining Nab-paclitaxel and carboplatin	Drug: AK112, Carboplatin, Paxlitaxel; The combination of AK112, a platinum-based chemotherapy agent, and Paxlitaxel is administered every three weeks as a neoadjuvant treatment for triple-negative breast cancer. After completing six cycles of this regimen, the participant undergoes surgical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR	pathological complete response	After surgery, within an average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	After complete 6 cycles of neoadjuvant chemotherapy in combination with AK112	Two weeks after completing 6 cycles of neoadjuvant therapy (each cycle is 21 days)

Collaborators and Investigators

• Sponsor: Shuangyue Liu

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: August 2, 2025
• First Posted (Actual): August 5, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 2, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: AK112 combining chemothrapy, neoadjuvant therapy, TNBC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Carboplatin
• Other Study ID Numbers: WestChinaL112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The informed consent documents approved by the ethics committee did not cover broad data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No