A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

Part of paid clinical trials in Tucson, Arizona.

Sponsor
DualityBio Inc.
Study ID
NCT05914116
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • DB-1311 — DRUG
    Administered I.V.(intravenous infusion)
  • Lopinavir and Ritonavir Tablets — DRUG
    Lopinavir and Ritonavir Tablets
  • itraconazole — DRUG
    itraconazole
  • Enzalutamide — DRUG
    oral administration
  • Abiraterone — DRUG
    oral administration

Study Details

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.

Key Dates

Start date
Aug 17, 2023
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
May 31, 2028

Study Design

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

Arms

  • Experimental: DB-1311/BNT324 Dose Level 1
    Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 1 on Day 1 of each cycle Q3W (every 3 weeks)
  • Experimental: DB-1311/BNT324 Dose Level 2
    Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 2 on Day 1 of each cycle Q3W
  • Experimental: DB-1311/BNT324 Dose Level 3
    Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 3 on Day 1 of each cycle Q3W
  • Experimental: DB-1311/BNT324 Dose Level 4
    Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 4 on Day 1 of each cycle Q3W
  • Experimental: DB-1311/BNT324 Dose Level 5
    Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 5 on Day 1 of each cycle Q3W
  • Experimental: DB-1311/BNT324 Dose Expansion 1
    Subjects with advanced/unresectable, or metastatic SCLC 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-1311/BNT324 randomized at dose level 1 or 2.
  • Experimental: DB-1311/BNT324 Dose Expansion 2
    Subjects with advanced/unresectable, or metastatic NSCLC 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-1311/BNT324 randomized at dose level 1 or 2.
  • Experimental: DB-1311/BNT324 Dose Expansion 3
    Subjects with advanced/unresectable, or metastatic ESCC 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-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 4
    Subjects with advanced/unresectable, or metastatic CRPC 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-1311/BNT324 randomized at dose level 1 or 2.
  • Experimental: DB-1311/BNT324 Dose Expansion 5
    Subjects with advanced/unresectable, or metastatic melanoma 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-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 6
    Subjects with advanced/unresectable, or metastatic HCC 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-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 7
    Subjects with advanced/unresectable, or metastatic cervical cancer 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-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 8
    Subjects with other advanced or metastatic solid tumors 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-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 9
    Subjects with advanced/unresectable, or metastatic HNSCC (not including nasopharyngeal carcinoma \[NPC\]) 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-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 10
    Subjects with advanced or metastatic rare tumor types 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-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 11
    Subjects with metastatic CRPC who have progressed on or after standard systemic treatments including no more than 2 lines of systemic chemotherapy, novel hormone therapy and lutetium-177 radioligand therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 12
    Taxane-naive subjects with metastatic CRPC who have progressed on or after novel hormone therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 13
    Subjects with advanced/unresectable, or metastatic HNSCC (not including NPC) 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-1311/BNT324.
  • Experimental: DB-1311/BNT324 Dose Expansion 14
    Subjects with epithelial OC who have had 1-3 prior lines of systemic treatment and are platinum-resistant, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.
  • Experimental: DB-1311/BNT324 Dose Expansion 15
    Subjects with Subjects with advanced/unresectable, or metastatic melanoma, ESCC, PROC and CC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via IV will be used for DB-1311/BNT324. Lopinavir and ritonavir/ Itraconazole will be administered orally twice a day/ once a day.
  • Experimental: DB-1311/BNT324 Dose Expansion 16
    Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg QD orally.
  • Experimental: DB-1311/BNT324 Dose Expansion 17
    Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with abiraterone 1000mg QD orally.
  • Experimental: DB-1311/BNT324 Dose Expansion 18
    CSPC subjects with suboptimal PSA response to ADT/NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg or abiraterone 1000mg QD orally.

Primary Outcome Measure

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by Common Terminology Criteria for Adverse Events (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 (28)

FacilityCityStateZIPSite coordinators
Research Site 111TucsonArizona85711-
Research Site 103Los AngelesCalifornia90095-
Research Site 125Los AngelesCalifornia90033-
Research Site 133Los AngelesCalifornia90067-
Research Site 128Santa MonicaCalifornia90403-
Research Site 118CelebrationFlorida34747-
Research Site 127MargateFlorida33063-
Research Site 137OrlandoFlorida32827-
Research Site 101PlantationFlorida33322-
Research Site 109TamaracFlorida33321-
Research Site 114AtlantaGeorgia30318-
Research Site 139AtlantaGeorgia30322-
Research Site 115LouisvilleKentucky40202-
Research Site 129DetroitMichigan48201-
Research Site 121Saint PaulMinnesota55101-
Research Site 110Las VegasNevada89169-
Research Site 107New YorkNew York10032-
Research Site 138CantonOhio44718-
Research Site 113CincinnatiOhio45267-
Research Site 131DaytonOhio45409-
Research Site 123CharlestonSouth Carolina29425-
Research Site 108GreenvilleSouth Carolina29607-
Research Site 136NashvilleTennessee37203-
Research Site 135AustinTexas78731-
Research Site 120DallasTexas75390-
Research Site 102FairfaxVirginia22031-
Research Site 112FairfaxVirginia22031-
Research Site 105SpokaneWashington99208-

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