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

Trial status:Recruiting
Trial ID:
DB-1311-201
NCT ID:
NCT06953089
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
DualityBio Inc.
Collaborator:
BioNTech SE
Recruiting

Trial Details

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

Medical Condition
  • Solid Tumors
    • Study Drug
  • DB-1311/BNT324
    • See more
  • BNT327
  • DB-1305/BNT325
    • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    492
    Estimated Trial Date
    Jul 2025 - Jun 2030

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    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
    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.

    Trial Locations

    Location
    Status
    Location
    USA06-0
    Los Angeles, California, United States, 90025
    Status
    Recruiting
    Location
    USA01-0
    Wheat Ridge, Colorado, United States, 80033
    Status
    Recruiting
    Location
    USA08-0
    Florida City, Florida, United States, 99208
    Status
    Recruiting
    Location
    USA04-0
    New York, New York, United States, 10032
    Status
    Recruiting
    Location
    USA02-0
    Pittsburgh, Pennsylvania, United States, 15232
    Status
    Recruiting
    Location
    USA03-0
    Charleston, South Carolina, United States, 29425
    Status
    Recruiting
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