A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

Part of paid clinical trials in Beverly Hills, California.

Sponsor
BioNTech SE
Study ID
NCT06827236
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • BNT323 — DRUG
    Intravenous infusion
  • BNT327 — DRUG
    Intravenous infusion

Study Details

This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).

Key Dates

Start date
Apr 23, 2025
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
380 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part1 - BNT323 + BNT327 combination therapy
    Escalating dose levels (DLs) of BNT323 and BNT327 to define RP2D. Six DLs are planned, i.e., DL0-1, DL1-1, DL2-1, DL0-0, DL1-0, DL2-0, a combination of three different DLs for BNT323 (DL0, DL1, and DL2) and two DLs for BNT327 (DL0 and DL1).
  • Experimental: Part 2 Cohort 1 - Arm 1 - RP2D of BNT323 + BNT327
  • Experimental: Part 2 Cohort 1 - Arm 2 - BNT323 + BNT327
  • Experimental: Part 2 Cohort 1 - Arm 3 - BNT323 monotherapy
    BNT323 monotherapy at a fixed dose
  • Experimental: Part 2 Cohort 1 - Arm 4 - BNT327 monotherapy
    BNT327 monotherapy at a fixed dose
  • Experimental: Part 2 Cohort 2 - RP2D of BNT323 + BNT327
  • Experimental: Part 2 Cohort 3 - RP2D of BNT323 + BNT327
  • Experimental: Part 2 Cohort 4 - RP2D of BNT323 + BNT327

Primary Outcome Measure

Part 1 - Occurrence of dose limiting toxicities (DLTs) [ Time Frame: During the DLT evaluation period (Cycle 1), i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
Hematology - Oncology Associates of the Treasure CoastPort Saint LucieFlorida34952-
University Cancer & Blood Center, LLCAthensGeorgia30607-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
START Midwest, LLCGrand RapidsMichigan49546-
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111-
Washington University School of MedicineSt LouisMissouri63110-
Summit Medical GroupFlorham ParkNew Jersey07932-
Memorial Sloan Kettering HospitalNew YorkNew York10065-
South Texas Accelerated Research Therapeutics (START), LLCSan AntonioTexas78229-

Find similar trials in Beverly Hills, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Beverly Hills Cancer Center· Beverly Hills, CAHematology - Oncology Associates of the Treasure Coast· Port Saint Lucie, FLUniversity Cancer & Blood Center, LLC· Athens, GAWinship Cancer Institute of Emory University· Atlanta, GASTART Midwest, LLC· Grand Rapids, MISaint Luke's Hospital of Kansas City· Kansas City, MO

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