A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
DualityBio Inc.
Study ID
NCT07141706
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced/Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

  • DB-1317 — DRUG
    Administered I.V.

Study Details

This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.

Key Dates

Start date
Sep 23, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: DB-1317 Dose Level 1
    Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 1 on Day 1 of each cycle Q3W
  • Experimental: DB-1317 Dose Level 2
    Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 2 on Day 1 of each cycle Q3W
  • Experimental: DB-1317 Dose Level 3
    Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 3 on Day 1 of each cycle Q3W
  • Experimental: DB-1317 Dose Level 4
    Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 4 on Day 1 of each cycle Q3W
  • Experimental: DB-1317 Dose Level 5
    Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 5 on Day 1 of each cycle Q3W
  • Experimental: DB-1317 Dose Expansion 1
    Subjects with advanced/unresectable, or metastatic Gastric cancer (GC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317
  • Experimental: DB-1317 Dose Expansion 2
    Subjects with advanced/unresectable, or metastatic colorectal cancer (CRC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317
  • Experimental: DB-1317 Dose Expansion 3
    Subjects with advanced/unresectable, or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317

Primary Outcome Measure

Phase 1a: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs [ Time Frame: up to 21 days after Cycle 1 Day 1 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
USA04-0Los AngelesCalifornia90025-
Site USA06-0PittsburghPennsylvania15232-
USA02-0HoustonTexas77030-
USA03-0San AntonioTexas78229-
USA01FairfaxVirginia22031-

Find similar trials in Los Angeles, CA

By research site
USA04-0· Los Angeles, CASite USA06-0· Pittsburgh, PAUSA02-0· Houston, TXUSA03-0· San Antonio, TXUSA01· Fairfax, VA

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