A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
BioNTech SE
Study ID
NCT07070232
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • BNT326 — DRUG
    Intravenous (IV) infusion
  • Pumitamig — DRUG
    IV infusion
  • Itraconazole — DRUG
    Oral administration
  • Paroxetine — DRUG
    Oral administration

Study Details

This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

Key Dates

Start date
Aug 12, 2025
Status verified
May 2026
Primary completion
Feb 29, 2028
Completion
Oct 31, 2029

Study Design

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

Arms

  • Experimental: Part 1 (Cohort 1A) - BNT326 monotherapy
    BNT326 (DL1 or DL2) in participants with cutaneous melanoma 2L+
  • Experimental: Part 1 (Cohort 1B) - BNT326 monotherapy
    BNT326 (DL1 or DL2) in participants with NSCLC 2L+ AGA-negative
  • Experimental: Part 1 (Cohort 1C) - BNT326 monotherapy
    BNT326 (DL1 or DL2) in participants with NSCLC 2L+ EGFRm
  • Experimental: Part 1 (Cohort 1D) - BNT326 monotherapy
    BNT326 (DL2) in participants with rare melanoma 2L+
  • Experimental: Part 1 (Cohort 1E) - BNT326 monotherapy
    BNT326 (DL2) in participants with advanced solid tumors 2L+
  • Experimental: Part 1 (Cohort 1F, DDI) - BNT326 + itraconazole
    BNT326 (DL1 or DL2) + itraconazole in participants with advanced solid tumors
  • Experimental: Part 1 (Cohort 1F, DDI) - BNT326 + paroxetine
    BNT326 (DL1 or DL2) + paroxetine in participants with advanced solid tumors
  • Experimental: Part 1 (Cohort 1G) - BNT326 monotherapy
    BNT326 (DL2) in participants with cervical cancer 2L+
  • Experimental: Part 2 (Cohort 2A) - BNT326 + pumitamig
    Combination therapy of BNT326 (DL1 or DL2) + pumitamig (DL1 or DL2) in participants with cutaneous melanoma 2L+. Optionally, combinations with lower doses of BNT326 and/or pumitamig may be explored.
  • Experimental: Part 2 (Cohort 2B) - BNT326 + pumitamig
    Combination therapy of BNT326 (DL1 or DL2) + pumitamig (DL1 or DL2) in participants with HER2-negative breast cancer (triple-negative breast cancer and hormone receptor positive \[HR+\]/HER2- breast cancer) 2L+/1L.
  • Experimental: Part 2 (Cohort 2C) - Optional - BNT326 + pumitamig
    Combination therapy of BNT326 (DL1 or DL2) + pumitamig (DL1) in participants with cutaneous melanoma 1L+
  • Experimental: Part 2 (Cohort 2D1) - BNT326 monotherapy
    BNT326 (DL2) in participants with GC/GEJC 2L+
  • Experimental: Part 2 (Cohort 2D2) - BNT326 + pumitamig
    Combination therapy of BNT326 (DL2) + pumitamig (DL1 or DL2) in participants with GC/GEJC 2L+
  • Experimental: Part 2 (Cohort 2E1) - BNT326 monotherapy
    BNT326 (DL2) in participants with colorectal cancer 2L+
  • Experimental: Part 2 (Cohort 2E2) - BNT326 + pumitamig
    Combination therapy of BNT326 (DL2) + pumitamig (DL1 or DL2) in participants with colorectal cancer 2L+
  • Experimental: Part 2 (Cohort 2F) - BNT326 + pumitamig
    Combination therapy of BNT326 (DL2) + pumitamig (DL2) in participants with cervical cancer 2L+

Primary Outcome Measure

Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), treatment emergent serious adverse events (TESAEs), and treatment related serious adverse events (TRSAEs) [ Time Frame: from first dose of investigational medicinal product (IMP) up to 42 days (Part 1) and 90 days (Part 2) after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to 26 months Part 1 or 27 months Part 2) ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
University of California San FranciscoSan FranciscoCalifornia94158-
Hartford HealthcareHartfordConnecticut06102-
Yale UniversityNew HavenConnecticut06511-
Florida Cancer SpecialistsSarasotaFlorida34232-
Moffitt Cancer CenterTampaFlorida33612-9497-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02215-
Brigitte Harris Cancer Pavilion BHCPDetroitMichigan48202-
START Midwest, LLCGrand RapidsMichigan49546-
Memorial Sloan Kettering HospitalNew YorkNew York10065-
Duke Cancer InstituteDurhamNorth Carolina27710-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics (START), LLCSan AntonioTexas78229-
START Mountain RegionWest Valley CityUtah84119-
The Board of Regents of the University of WisconsinMadisonWisconsin53792-6188-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Arizona· Phoenix, AZUniversity of California San Francisco· San Francisco, CAHartford Healthcare· Hartford, CTYale University· New Haven, CTFlorida Cancer Specialists· Sarasota, FLMoffitt Cancer Center· Tampa, FL

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