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

Part of paid clinical trials in Los Angeles, California.

Sponsor
DualityBio Inc.
Study ID
NCT06953089
Phase
PHASE2
Status
Recruiting
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Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DB-1311/BNT324 — DRUG
    Administered I.V.
  • BNT327 — DRUG
    Administered I.V.
  • DB-1305/BNT325 — DRUG
    Administered I.V.

Study 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

Key Dates

Start date
Jul 18, 2025
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapy
    Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D (Recommended Phase 2 Dose) and RP2D-1 in target population.
  • Experimental: Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy
    Escalating combination dose levels of DB-1311/BNT324 and DB-1305/BNT325 to define RP2D and RP2D-1 in target population.
  • Experimental: Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327
    In participants with unresectable advanced/metastatic HCC
  • Experimental: Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327
    In participants with unresectable advanced/ metastatic CC
  • Experimental: Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327
    In participants with unresectable advanced/metastatic melanoma
  • Experimental: Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327
    In participants with recurrent/metastatic HNSCC
  • Experimental: Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325
    In participants with advanced/unresectable metastatic NSCLC
  • Experimental: Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapy
    Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D and RP2D-1 in target population.
  • Experimental: Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327
    In participants with unresectable advanced/metastatic PSOC
  • Experimental: Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327
    In participants with unresectable advanced/metastatic PDAC
  • Experimental: Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327
    In participants with unresectable advanced/metastatic breast cancer
  • Experimental: Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327
    In participants with unresectable advanced/metastatic CRC
  • Experimental: Part 2 Arm 10: RP2D of DB-1311/BNT324 + BNT327
    In participants with unresectable advanced/metastatic mCRPC

Primary Outcome Measure

Part 1: Number of participants with Dose Limiting Toxicities (DLTs). [ Time Frame: During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
USA06-0Los AngelesCalifornia90025-
USA16-0Los AngelesCalifornia90025-
USA01-0Wheat RidgeColorado80033-
USA08-0Florida CityFlorida99208-
USA10-0AtlantaGeorgia30318-
USA11-0BethesdaMaryland20817-
USA14-0LincolnNebraska68506-
USA04-0New YorkNew York10032-
USA15-0PortlandOregon97239-
USA03-0CharlestonSouth Carolina29425-
USA13-0AndersonTexas46011-
USA12-0HoustonTexas77030-
USA05-0Virginia BeachVirginia22031-
USA09-0PuyallupWashington98373-
USA07-0SpokaneWashington99208-

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