RecruitingPhase 2NCT06953089

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Checked against the public recordLast updated May 22, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 2
U.S. locations37
SponsorDualityBio Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
DualityBio Inc.
Interventions being studied
Drug: DB-1311/BNT324; Drug: BNT327; Drug: DB-1305/BNT325
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Criteria: * 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • USA06-0Los Angeles, California
  • USA16-0Los Angeles, California
  • USA01-0Wheat Ridge, Colorado
  • USA08-0Florida City, Florida
  • USA10-0Atlanta, Georgia
  • USA11-0Bethesda, Maryland
  • USA14-0Lincoln, Nebraska
  • USA04-0New York, New York
  • USA15-0Portland, Oregon
  • USA03-0Charleston, South Carolina
  • USA13-0Anderson, Texas
  • USA12-0Houston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 22, 2026. Always confirm current availability with the study team.

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