Study of DB-1311 with BNT327 or DB-1305 for Advanced Solid Tumors
This study is testing two combinations of medicines, DB-1311 with BNT327, or DB-1311 with DB-1305, for people with advanced or metastatic (spread) solid tumors. These tumors can include various types like breast cancer, lung cancer, and ovarian cancer. The main goals are to understand the safety of these combinations, looking for side effects (adverse events) and how much medicine can be given safely. The study plans to enroll up to 450 participants. You might be able to join if you are an adult aged 18 or older, have a measurable tumor, and a life expectancy of at least 3 months.
- Study design
- This is a Phase II, multicenter, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll up to 450 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for up to 72 months (6 years) after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06953089
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Recruiting
PHASE2Ages 18+InterventionalTreatmentDualityBio Inc.
~450 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:DB-1311/BNT324BNT327DB-1305/BNT325
At a glance
Recruiting sites
37 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of participants with Dose Limiting Toxicities (DLTs).
Measured over During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days
+3 more outcomes measured
Conditions
Where it's being run
37 sites across 26 statesBeijing Municipality3
Hubei3
California2
Texas2
Washington2
Queensland2
Henan2
Shanghai Municipality2
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.
At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.
Has a life expectancy of ≥ 3 months.
Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Has adequate organ function within 7 days prior to enrollment/randomization,
Has adequate treatment washout period prior to the first dose of trial treatment.
For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score.
For CC patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology
For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma.
For PROC patients (Cohort A): Participants must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous histology. Patients must have platinum-resistant disease.
For HNSCC patients: Histologically or cytologically confirmed recurrent (recurrent disease that is not amendable to curative treatment with local/ or systemic therapies)/ (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
For NSCLC patients: Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSQ NSCLC. Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations
For PSOC: Must have PSOC, defined as radiographically documented disease recurrence or progression occurring \>6 months after completion of the last dose of platinum-based chemotherapy.
For PDAC: Participants must have histologically or cytologically confirmed metastatic PDAC., who have progressed after at least one prior line of standard systemic treatment ((≥2L PDAC).)
For breast cancer:
HR+/HER2-low or HR+/HER2-ultralow or HR+/HER2-negative BC participants: Pathologically or cytologically documented HR-positive unresectable or metastatic BC with HER2-low, HER2-ultralow or HER2-negative expression.
Triple negative breast cancer (TNBC): Pathologically or cytologically documented unresectable or metastatic TNBC
For mCRC: Participants who have metastatic CRC and have relapsed or progressed after 1 prior line of systemic treatment including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or have relapsed or progressed after 2 lines of therapy if the participant has received targeted therapy
For mCRPC: Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and mCRPC
Exclusion
1\. Prior treatment with B7H3 targeted therapy.
Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.
Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.
Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.
Has uncontrolled or significant cardiovascular disease. Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy.
Has a history of (non-infectious) ILD/pneumonitis.
Any autoimmune, connective tissue or inflammatory disorders.
Has spinal cord compression or clinically active central nervous system (CNS) metastases.
Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.
What this trial measures
- Part 1: Number of participants with Dose Limiting Toxicities (DLTs).During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days
- Part 1: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs)up to follow up period, e.g. up to 72 months.
- Part 2: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) [By arm and dose level]From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
- Part 2: Objective response rate (ORR), defined as the proportion of participants in whom a confirmed Complete response (CR) or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment)by arm and dose level.From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months