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New treatment option for Triple-Negative Breast Cancer (TNBC)
Official title A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
ClinicalTrials.gov ID: NCT06732323
What this study is testing
What is ESG401?
ESG401 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple-negative breast cancer (tnbc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to evaluate the efficacy and safety of ESG401 as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males or females aged ≥ 18 years ;
- 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 tumours are PD-L1-positive and have relapsed after prior PD-1/PD-L1 inhibitor...
You likely can't join if
- Use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration.
- Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
- Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy, or prior TROP2 targeted therapy.
- New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months.
- people with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.
- Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose.
See the full eligibility criteria
- Males or females aged ≥ 18 years ;
- 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 tumours are PD-L1-positive and have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer, or comorbidities precluding...
- Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator;
- 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 12 weeks;
- Adequate organ and bone marrow function. Key
- Use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration.
- Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
- Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy, or prior TROP2 targeted therapy.
- New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months.
- people with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.
- Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose.
- Patients with uncontrollable systemic diseases.
- Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea.
- people with clinically significant cardiovascular disease.
- Human Immunodeficiency Virus (HIV) infection.
- Active hepatitis B or hepatitis C.
- Known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to...
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.