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

First listed
Dec 4, 2025
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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