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DB-1305/BNT325

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |BioNTech SE|Last Updated: May 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,123
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05438329First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 1,123 — — Jul 19, 2022Sep 10, 2027May 12, 202693 United States, China +1
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Study Endpoints
Primary Endpoints
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
up to 28 days after Cycle 1 Day 1

Percentage of participants in Part 1 with DLTs

Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.

Percentage of participants with TEAEs in Part 1 graded according to NCI CTCAE v5.0

Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Up 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.

Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0

Maximum Tolerated Dose (MTD) of DB-1305/BNT325
At the end of Cycle 1 (each cycle is up to 21 days)

MTD on the data collected during Part 1

Phase 1: RP2D of DB-1305/BNT325
From first study treatment administration until the initiation of Phase 2a, approximately up to 12 months.

RP2D of DB-1305/BNT325 based on the data collected during Part 1

Phase 2a: Percentage of Participants with TEAEs as assessed by CTCAE v5.0.
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.

Percentage of participants with TEAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)

Phase 2a: Percentage participants with SAEs as assessed by CTCAE v5.0.
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.

Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)

Phase 2a: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.

The percentage of subjects who had a best response rating of CR and PR

Secondary Endpoints
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator per RECIST 1.1
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: disease-control rate (DCR)
with 8 cycles (each cycle is up to 21 days)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DB-1305/BNT325 Dose Level 1EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 1
DB-1305/BNT325 Dose Level 2EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 2
DB-1305/BNT325 Dose Level 3EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 3
DB-1305/BNT325 Dose Level 4EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 4
DB-1305/BNT325 Dose Level 5EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 5
DB-1305/BNT325 Dose Level 6EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 6
DB-1305/BNT325 Dose Level 7EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 7
DB-1305/BNT325 in combination with pembrolizumabEXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab
DB-1305/BNT325 Dose Expansion 1EXPERIMENTALsubjects with Non-Small Cell Lung Cancer (NSCLC) with actionable genetic alterations (AGAs) who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
DB-1305/BNT325 Dose Expansion 2EXPERIMENTALEnrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
DB-1305/BNT325 Dose Expansion 3EXPERIMENTALEnrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
DB-1305/BNT325 Dose Expansion 4EXPERIMENTALEnrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 5EXPERIMENTALEnrolled subjects with Triple-Negative Breast Cancer (TNBC) who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 6EXPERIMENTALEnrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 7EXPERIMENTALEnrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 8EXPERIMENTALEnrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 9EXPERIMENTALEnrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Experimental: DB-1305/BNT325 Dose Expansion 10EXPERIMENTALEnrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion 11EXPERIMENTALEnrolled subjects with Castration-Resistant Prostate Cancer (CRPC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Expansion PB1EXPERIMENTALEnrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with pembrolizumab
Experimental: DB-1305/BNT325 Dose Level 8EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 8
Experimental: DB-1305/BNT325 in combination with BNT327EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM1EXPERIMENTALEnrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM2EXPERIMENTALEnrolled subjects with NSCLC with AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM3EXPERIMENTALEnrolled subjects with CC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM4EXPERIMENTALEnrolled subjects with OC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM5EXPERIMENTALEnrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
DB-1305/BNT325 Dose Expansion 12EXPERIMENTALEnrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)
DB-1305/BNT325 Dose Level 9EXPERIMENTALEnrolled subjects will receive DB-1305/BNT325 at Dose Level 9
DB-1305/BNT325 Dose Expansion PM6EXPERIMENTALEnrolled subjects with NSCLC without AGA who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Interventions
NameTypeDescription
DB-1305/BNT325DRUGAdministered Injection of Vein (I.V.)
PembrolizumabCOMBINATION_PRODUCTAdministered I.V.
BNT327DRUGAdministered I.V.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites93

Inclusion Criteria: * Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent). * Histologically or cytologically confirmed unresectable advanced/ metastatic solid tumors who have relapsed or progres...

Countries:United StatesChinaPuerto Rico
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05438329Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT05438329studyFirstPostDate: changed