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Chemotherapy

DB-1303 for Breast Cancer

Phase 3
Recruiting
Research Sponsored by DualityBio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically documented breast cancer that is advanced or metastatic, has HER2-low expression (IHC 1+ or IHC 2+/ISH-), was never previously reported as HER2-positive (IHC 3+ or ISH+), and is documented as HR+ (ER and/or PgR positive [ER or PgR ≥1%])
Must have an adequate tumor tissue sample available for assessment of HER2 by central laboratory, preferably in formalin fixation and paraffin embedding (FFPE) blocks based on a mandatory FFPE tumor sample obtained at the time of metastatic disease or later
Must not have
Uncontrolled intercurrent illness, including ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent
Clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to the randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 51 months
Awards & highlights

Summary

This trial will compare the effectiveness of two treatments for HR+/HER2- breast cancer in terms of progression-free survival.

Who is the study for?
Adults with advanced or metastatic breast cancer that is HR+, HER2-low, and have not had chemotherapy for this stage of the disease. They must be in good physical condition (ECOG 0 or 1), have a life expectancy over 12 weeks, and agree to use effective contraception. Those who've progressed on endocrine therapy plus CDK4/6 inhibitor or two lines of endocrine therapy are eligible.
What is being tested?
The trial tests DB-1303 against standard chemotherapies like Paclitaxel, Nab-paclitaxel, Capecitabine chosen by the investigator. It measures how long patients live without their cancer getting worse using blinded independent review.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk and bleeding problems. Specific side effects of DB-1303 are not listed but may be similar to other drugs in its class.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is advanced, not previously HER2-positive, but has low HER2 and is hormone receptor positive.
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I have a tumor tissue sample available for HER2 testing.
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I am fully active or can carry out light work.
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My cancer worsened within 6 months on specific breast cancer treatments and I'm considered suitable for chemotherapy.
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My doctor expects me to live for at least 12 more weeks.
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I have a tumor that can be measured or bone disease assessable by scans.
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I am a man who can father children and will use a condom with spermicide during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious illnesses or conditions that would stop me from following the study rules.
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I haven't needed treatment for fluid buildup in my chest or abdomen in the last 2 weeks.
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I have serious heart problems that are not well-managed.
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I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.
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I still have side effects from cancer treatment, except for hair loss, that haven't improved.
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I cannot receive standard chemotherapy treatments.
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I have been treated with anti-HER2 therapy before.
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I have been treated with a specific drug that targets cancer cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 51 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 51 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS) in the HR+, HER2-low population
Secondary study objectives
Duration of response (DoR) in the HR+, HER2-low population
European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)
Objective response rate (ORR) in the HR+, HER2-low population
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DB-1303/BNT323Experimental Treatment1 Intervention
Enrolled Subjects will be randomized to receive a 8 mg/kg IV dose of DB-1303/BNT323 on Day 1 of each cycle Q3W
Group II: investigator's choice single agent chemotherapyActive Control3 Interventions
Enrolled Subjects will be randomized to receive investigator's choice single agent chemotherapy (capecitabine:1000 or 1250 mg/m2, Oral, Twice daily orally for 2 weeks followed by a 1-week rest period in 3-week cycles; paclitaxel：80 mg/m2， IV, Every week (QW) in 3-week cycles; or nab-paclitaxel: 100 mg/m2, IV, Every week (QW) for 3 weeks followed by a one-week rest period in 4-week cycles) until RECIST 1.1 defined disease progression (PD), unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.

Find a Location

Who is running the clinical trial?

BioNTech SEIndustry Sponsor
70 Previous Clinical Trials
109,756 Total Patients Enrolled
DualityBio Inc.Lead Sponsor
8 Previous Clinical Trials
2,745 Total Patients Enrolled
Raymond ZhaoStudy DirectorDualityBio Inc.
3 Previous Clinical Trials
654 Total Patients Enrolled
~339 spots leftby Dec 2025
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