A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

NCT06279364 | Recruiting Phase 3 DMC

• 1 other identifier: SKB264-Ⅲ-11
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  OS is defined as the time from randomization until the date of death due to any cause.

  Randomization up to approximately 40 months

• Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

  PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.

  Randomization up to approximately 28 months

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Randomization up to approximately 28 months

• Duration of Response (DoR)

  Randomization up to approximately 28 months

• Progression-Free Survival (PFS) assessed by Investigator

  Randomization up to approximately 28 months

• Disease control rate (DCR)

  Randomization up to approximately 28 months

• Time to Response (TTR)

  Randomization up to approximately 28 months

Study Arms (2)

SKB264

EXPERIMENTAL

Participants will receive SKB264 on Day 1 and Day 15 of each 4-week cycle

Drug: SKB264

Investigator's choice chemotherapy

ACTIVE COMPARATOR

If no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) \>12 months: paclitaxel or nab-paclitaxel. If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin

Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Capecitabine; Drug: Eribulin; Drug: Carboplatin

Interventions

SKB264 DRUG

IV Infusion

SKB264

Paclitaxel DRUG

IV Infusion.

Investigator's choice chemotherapy

Nab-paclitaxel DRUG

IV infusion.

Investigator's choice chemotherapy

Capecitabine DRUG

Tablet. Oral route of administration.

Investigator's choice chemotherapy

Eribulin DRUG

IV infusion.

Investigator's choice chemotherapy

Carboplatin DRUG

IV infusion.

Investigator's choice chemotherapy

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 and/or cytologically confirmed TNBC.
• De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent.
• No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease.
• Participants whose tumours are PD-L1-negative, or participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease.
• At least one measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization.
• A life expectancy of at least 3 months.
• Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator.
• Adequate organ and bone marrow function.

You may not qualify if:

• Active second malignancy.
• Uncontrolled or clinical significant cardiovascular disease.
• History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
• Active infection requiring systemic therapy within 2 weeks of randomization.
• Active hepatitis B or hepatitis C virus infection.
• Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
• Known hypersensitivity to SKB264 or its excipients.
• Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors.
• Prior treatment with the same investigator's choice chemotherapy (except taxane).
• Pregnant or lactating women.

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Paclitaxel; 130-nm albumin-bound paclitaxel; Capecitabine; eribulin; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes

Central Study Contacts

Xiaoping Jin, PhD

CONTACT

86-028-67255165; jinxp@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomised in a 1:1 ratio to one of two intervention groups.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

CN (1)