A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors

Part of paid clinical trials in Port Saint Lucie, Florida.

Sponsor
DualityBio Inc.
Study ID
NCT07263594
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Gastrointestinal Cancer

Eligibility Criteria

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

Interventions

  • DB-1324 — DRUG
    Administered I.V.

Study Details

This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.

Key Dates

Start date
Jan 20, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
127 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: DB-1324 Phase 1 Dose escalation
    Enrolled Subjects will receive a single-dose of DB-1324 at different Dose Level or different dose regimen
  • Experimental: DB-1324 Phase 1 Backfill
    Participants with GI cancers who have received no more than 3 prior lines of systemic therapy may be backfilled at the selected dose regimens to further explore the safety, efficacy, PK, and pharmacodynamics of DB-1324.
  • Experimental: DB-1324 Phase 1 Dose Expansion
    Two or more appropriate dose regimens of DB-1324, determined from the emerging dose escalation (and backfill) data, will be explored for preliminary efficacy and safety of DB-1324.
  • Experimental: DB-1324 Phase 2
    Phase 2 will consist of one or more cohorts intended to confirm early signals of efficacy identified in Phase 1.

Primary Outcome Measure

Dose Escalation and Backfill parts: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. [ Time Frame: Up to safety follow-up visit, approximately 30 days post-treatment ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
USA05-0Port Saint LucieFlorida34952-
USA02-0Grand RapidsMichigan49546-
USA01-0HuntersvilleNorth Carolina28078-
USA03-0CincinnatiOhio45219-

Find similar trials in Port Saint Lucie, FL

By research site
USA05-0· Port Saint Lucie, FLUSA02-0· Grand Rapids, MIUSA01-0· Huntersville, NCUSA03-0· Cincinnati, OH

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