Study of SKB103 in HER2-negative Breast Cancer

NCT07774624 | Not Yet Recruiting Phase 1

• 1 other identifier: SKB103-I/II-02
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer. The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage.

Conditions

Breast Cancer

Keywords

HER2-negative Breast Cancer; Breast Cancer; SKB103

Outcome Measures

Primary Outcomes (2)

• Number of subjects achieving Dose-limiting toxicity (DLT)

  DLT is defined as any adverse event (AE) that meets protocol-defined DLT criteria, occurring in the first 21 days, and considered at least possibly drug-related.

  Within the first 21 days following the initial dose.

• Objective response rate(ORR)

  ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) as the best overall response assessed per RECIST 1.1.

  Up to approximately 3 years

Secondary Outcomes (7)

• Progression-free survival (PFS)

  Up to approximately 3 years

• Duration of Response (DOR)

  Up to approximately 3 years

• Disease control rate (DCR)

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 3 years

• Cmax

  Up to approximately 3 years

Study Arms (1)

Participant Group

EXPERIMENTAL

Drug: SKB103 monotherapy

Interventions

SKB103 monotherapy DRUG

SKB103 for injection, administered as monotherapy via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks, Q3W). Treatment continues until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death, whichever occurs first.

Participant Group

Eligibility Criteria

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

You may qualify if:

• Willingness to participate in the study, sign the informed consent form(ICF), and comply with the protocol-specified visits and relevant procedures.
• Aged ≥ 18 and ≤ 75 years at the time of signing ICF.
• Histologically and/or cytologically confirmed HER2-negative Breast cancer who have failed standard therapy.
• Participants should provide tumor tissue samples for biomarker testing as much as possible.
• At least one measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.
• Life expectancy ≥ 12 weeks.
• Acceptable bone marrow and organ function.
• Male and female participants must agree to use highly effective contraceptive methods during the study period.

You may not qualify if:

• Participants with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, and active central nervous system (CNS) metastases.
• Participants with other malignant tumors within 3 years prior to the first administration.
• Presence of any serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• Presence of any uncontrolled systemic disease, as judged by the investigator.
• Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
• History of interstitial lung disease or noninfectious pneumonitis.
• Other lung diseases that may interfere with drug-related pulmonary toxicity or may cause clinically serious lung injuries.
• Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disorders that prevent/delay corneal healing.
• Presence of risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding vital organs and major blood vessels with related clinical symptoms.
• Clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess within 3 months prior to the first administration.
• Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
• Has experienced immune-related adverse events (irAE) of Grade 3 or higher during prior immunotherapy
• Serious infection occurred within 4 weeks prior to the first administration.
• Active hepatitis B or hepatitis C.
• Positive result of human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yina Diao

CONTACT

86-028-67252634; diaoyina@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 19, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share