First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
DualityBio Inc.
Study ID
NCT06554795
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

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

Interventions

  • DB-1419 — DRUG
    Administered Injection of Vein (I.V.)

Study Details

A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors

Key Dates

Start date
Sep 3, 2024
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    Enrolled subjects will receive DB-1419 at Dose Level 1
  • Experimental: Dose Level 2
    Enrolled subjects will receive DB-1419 at Dose Level 2
  • Experimental: Dose Level 3
    Enrolled subjects will receive DB-1419 at Dose Level 3
  • Experimental: Dose Level 4
    Enrolled subjects will receive DB-1419 at Dose Level 4
  • Experimental: Dose Level 5
    Enrolled subjects will receive DB-1419 at Dose Level 5
  • Experimental: Dose Level 6
    Enrolled subjects will receive DB-1419 at Dose Level 6
  • Experimental: Dose Expansion 1
  • Experimental: Dose Expansion 2
  • Experimental: Dose Expansion 3
  • Experimental: Dose Expansion 4
  • Experimental: Dose Expansion 5
  • Experimental: Dose Expansion 6
  • Experimental: Dose Expansion 7
  • Experimental: Dose Expansion 8
  • Experimental: Dose Level 7
    Enrolled subjects will receive DB-1419 at Dose Level 7
  • Experimental: Dose Level 8
    Enrolled subjects will receive DB-1419 at Dose Level 8
  • Experimental: Dose Level 9
    Enrolled subjects will receive DB-1419 at Dose Level 9

Primary Outcome Measure

Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE) [ Time Frame: Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Site USA12-0Los AngelesCalifornia90095-
Site USA08-0Newport BeachCalifornia92663-
Site USA06-0Washington D.C.District of Columbia20007-
Site USA02-0Florida CityFlorida32827-
Site USA11-0ChicagoIllinois60637-
Site USA03HuntersvilleNorth Carolina28078-
Site USA05-0PhiladelphiaPennsylvania19107-
Site USA07-0NashvilleTennessee37203-
Site USA09-0West Valley CityUtah84119-

Find similar trials in Los Angeles, CA

By research site
Site USA12-0· Los Angeles, CASite USA08-0· Newport Beach, CASite USA06-0· Washington D.C., DCSite USA02-0· Florida City, FLSite USA11-0· Chicago, ILSite USA03· Huntersville, NC

Related Studies