A Study of DB-1310 in Advanced/Metastatic Solid Tumors

Part of paid clinical trials in Sacramento, California.

Sponsor
DualityBio Inc.
Study ID
NCT05785741
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • DB-1310 — DRUG
    Administered I.V.
  • Trastuzumab — DRUG
    Administered I.V.
  • Osimertinib — DRUG
    Oral
  • capecitabine — DRUG
    Oral

Study Details

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.

Key Dates

Start date
Aug 17, 2023
Status verified
Mar 2026
Primary completion
Dec 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: DB-1310 Dose Level 1
    Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Level 2
    Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 2 on Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Level 3
    Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 3 on Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Level 4
    Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 4 on Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Level 5
    Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 5 on Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Level 6
    Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Level 7
    Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Level 8
    Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab
  • Experimental: DB-1310 Dose Level 9
    Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab
  • Experimental: DB-1310 Dose Level 10
    Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab
  • Experimental: DB-1310 Dose Level 11
    Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib
  • Experimental: DB-1310 Dose Level 12
    Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib
  • Experimental: DB-1310 Dose Level 13
    Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib
  • Experimental: DB-1310 Dose Expansion 1
    Enrolled Subjects with advanced/unresectable, or metastatic adenocarcinoma NSCLC with EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Expansion 2
    Enrolled Subjects with advanced/unresectable, or metastatic NSCLC without EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Expansion 3
    Enrolled Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Expansion 4
    Enrolled Subjects with advanced/unresectable, or metastatic HNSCC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Expansion 5
    Enrolled Subjects with advanced/unresectable, or metastatic BC with HER2-positive (IHC3+, or IHC2+ and ISH+) who have progressed on or after HER2 targeted systemic treatments will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with trastuzumab deruxtecan.
  • Experimental: DB-1310 Dose Expansion 6
    Enrolled Subject with other advanced/unresectable, or metastatic solid tumors who have progressed on or after standard systemic treatment, or for which no standard systemic treatment is available will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Experimental: DB-1310 Dose Expansion 7
    Enrolled subjects with advanced/unresectable, or metastatic non-squamous NSCLC with EGFR exon 19 deletion or L858R mutation who haven't received any treatment in locally advanced, or metastatic disease will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with Osimertinib.
  • Experimental: DB-1310 Dose Expansion 8
    Enrolled subjects with NSCLC with EGFR who will receive DB-1310 on a selected dose level in combination with Osimertinib
  • Experimental: DB-1310 Dose Expansion 9
    Enrolled subjects with NSCLC with KRAS mutation who will receive DB-1310 on a selected dose level (RP2D)
  • Experimental: DB-1310 Dose Expansion 10
    Enrolled subjects with ESCC who will receive DB-1310 on a selected dose level (RP2D)
  • Experimental: DB-1310 Dose Expansion 11
    Enrolled subjects with BTC who will receive DB-1310 on a selected dose level (RP2D)
  • Experimental: DB-1310 Dose Expansion 12
    Enrolled subjects with HR+/HER2- BC who will receive DB-1310 on a selected dose level in monotherapy or combination with capecitabine

Primary Outcome Measure

Phase 1: 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 (15)

FacilityCityStateZIPSite coordinators
University of California, Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Tianhong Li, PhD
UCLA Hematology/Oncology - Santa MonicaSanta MonicaCalifornia90404
Aaron E. Lisberg, MD
Research Site 117Coral GablesFlorida33146-
D&H Cancer Research Center LLCMargateFlorida33063-
Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlandoFlorida32827
Cesar Batista, MD
BRCR globalPlantationFlorida33322
H Amin, MD
Florida Cancer SpecialistsSarasotaFlorida34232
Judy SZ Wang, MD
BRCR Medical Center Inc.TamaracFlorida33321
Chintan Gandhi
Research Site 111AtlantaGeorgia30322
Jacqueline Brown, MD
Dana-Farber Cancer InstituteBostonMassachusetts02215
Julia Rotow, MD
Henry Ford Health SystemDetroitMichigan48202
Amy Weise, DO
Research site 119Florham ParkNew Jersey07932-
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer CenterCincinnatiOhio45219
Brittany-Belle Gordon, MD,
Tennessee Oncology, PLLCNashvilleTennessee37203
Erika P. Hamilton, MD
NEXT VirginiaFairfaxVirginia22031
A Spira, MD

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