FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

NCT ID: NCT06519370

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-09
• Study Completion Date: 2027-06-20

Brief Summary

This is a Phase III, randomized, open-label, 2-arm, multicentre, international study assessing the efficacy and safety of FDA018-ADC compared with Investigator's Choice Chemotherapy(ICC) in participants with locally recurrent inoperable or metastatic Triple-negative Breast Cancer(TNBC) who are resistant to, or recurring during or after taxane therapy.

Detailed Description

The primary objectives of the study are to demonstrate the superiority of FDA018-ADC relative to ICC by assessment of PFS per Blinded Independent Central Review(BICR) and OS in participants with locally recurrent inoperable or metastatic TNBC who are resistant to, or recurring during or after taxane therapy.

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FDA018-ADC

Subjects will receive FDA018-ADC 10 mg/kg of body weight via intravenous(IV) infusion on Day1 and 8 of a 21-day cycle in follow-up period until disease progression, unacceptable toxicity or death.

Group Type: EXPERIMENTAL

FDA018-ADC

Intervention Type: DRUG

Subjects will receive FDA018-ADC 10 mg/kg of body weight via intravenous(IV) infusion on Day1 and 8 of a 21-day cycle in follow-up period until disease progression, unacceptable toxicity or death.

Investigator's Choice of Chemotherapy (ICC)

Participants will receive ICC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that is selected by the investigator before participant randomization. Participants will continue treatment until disease progression, unacceptable toxicity or death.

Group Type: ACTIVE_COMPARATOR

Eribulin

Intervention Type: DRUG

1.4mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle

Capecitabine

Intervention Type: DRUG

1000 to 1250 mg/m\^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest

Gemcitabine

Intervention Type: DRUG

800 to 1200 mg/m\^2 will be administered IV on day 1 and Day 8 of each 21 day cycle

Vinorelbine

Intervention Type: DRUG

25 mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle

Interventions

FDA018-ADC

Subjects will receive FDA018-ADC 10 mg/kg of body weight via intravenous(IV) infusion on Day1 and 8 of a 21-day cycle in follow-up period until disease progression, unacceptable toxicity or death.

Intervention Type: DRUG

Eribulin

1.4mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle

Intervention Type: DRUG

Capecitabine

1000 to 1250 mg/m\^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest

Intervention Type: DRUG

Gemcitabine

800 to 1200 mg/m\^2 will be administered IV on day 1 and Day 8 of each 21 day cycle

Intervention Type: DRUG

Vinorelbine

25 mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle

Intervention Type: DRUG

Other Intervention Names

FDA018-Antibody-drug Conjugate; Halaven; Xeloda; Gemzar; Navelbine

Eligibility Criteria

Inclusion Criteria

1. Patients capable to give written informed consent;

2. Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization;

3. Prior exposure to a taxane in localized or advanced/metastatic setting, and recurred during or after treatment;

4. Eligible for one of the chemotherapy options listed as ICC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment;

5. Have measurable lesions defined in RECIST v.1.1, those with only skin or bone lesions cannot be included;

6. Expected survival≥3 months;

7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;

8. Adequate bone marrow, hepatic, and renal function;

9. All acute toxicity of previous anti-tumor treatment or surgery is relieved to baseline severity or NCI CTCAE version 5.0≤1;

10. Subjects could provide tumor tissues or tissue specimens;

11. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.

Exclusion Criteria

1. Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;

2. Have central nervous system metastasis with clinical symptoms;

3. Have history of clinical significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness present within 6 months prior to the first dose;

4. Suffering from active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease), and history of intestinal obstruction, or Gl perforation;

5. Patients with Gilbert's disease or heterozygous for the UGT1A1*28 allele;

6. Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive;

7. Patients who have received prior TROP-2-targeted therapy;

8. Patients who have received prior topoisomerase I inhibitor contained therapy;

9. Received other anti-tumor treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, experimental treatment and so on) within 4 weeks prior to the first dose;

10. Patients who have received live vaccines within 4 weeks prior to the first dose;

11. Patients who had undergone major surgery or severe trauma within 4 weeks prior to the first dose;

12. Patients who had undergone systemic high-dose steroids within 2 weeks prior to the first dose;

13. Patients have history of psychotropic drug abuse, alcohol or drug abuse;

14. Women who are pregnant or lactating;

15. Other circumstances that is deemed not appropriate for the study by investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Zhang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

F0024-301

Identifier Type: -

Identifier Source: org_study_id