BNT327
Sponsors
BioNTech SE, DualityBio Inc.
Conditions
Advanced Breast Cancer
Metastatic Breast CancerAdvanced Lung CancerAdvanced Solid TumorAdvanced solid tumorsEnglish
First-line extensive-stage small-cell lung cancer (ES-SCLC)First line triple-negative breast cancer (TNBC)Locally Advanced Breast CancerMetastatic Breast Cancer
Phase 1
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
RecruitingNCT05438329
Start: 2022-07-19End: 2025-06-30Target: 1123Updated: 2025-02-27
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
RecruitingNCT06827236
Start: 2025-04-23End: 2029-05-01Target: 380Updated: 2026-03-20
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
RecruitingNCT06892548
Start: 2025-05-02End: 2031-06-01Target: 594Updated: 2026-03-19
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer
RecruitingNCT07079631
Start: 2025-07-18End: 2031-05-01Target: 482Updated: 2026-03-06
A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)
RecruitingNCT07111520
Start: 2025-09-22End: 2030-01-31Target: 420Updated: 2025-10-22
A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors
RecruitingNCT07147348
Start: 2025-08-27End: 2028-03-31Target: 375Updated: 2025-10-01
A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with cancer immunotherapies in participants with advanced solid tumors
RecruitingCTIS2024-517261-16-00
Start: 2025-12-05Target: 172Updated: 2025-10-22
A Phase I/II, randomized, multi-site trial to investigate the efficacy and safety of BNT314 in combination with BNT327 and chemotherapy in participants with metastatic colorectal cancer
RecruitingCTIS2025-521768-36-00
Start: 2026-01-27Target: 168Updated: 2025-10-22
A Phase I/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, and pharmacokinetics of BNT323 in combination with BNT327 in participants with advanced breast cancer
Not yet recruitingCTIS2024-517979-20-00
Target: 95Updated: 2025-11-17
A Phase Ib/II, multi-site, open-label, dose finding trial to evaluate the safety, efficacy, and pharmacokinetics of BNT326 in combination with BNT327 in participants with advanced non-small cell lung cancer (NSCLC)
Not yet recruitingCTIS2024-519344-32-00
Target: 88Updated: 2026-01-27
A Phase Ib/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, pharmacokinetics, and recommended combination dose of BNT324 with BNT327 in participants with advanced lung cancer
Not yet recruitingCTIS2024-520238-31-01
Target: 26Updated: 2026-02-24
Phase 2
Phase II/III, multisite, randomized master protocol for a global trial of BNT327 in combination with chemotherapy and other investigational agents in first-line non-small cell lung cancer
RecruitingCTIS2024-515764-31-00
Start: 2025-06-13Target: 470Updated: 2026-01-26
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
RecruitingNCT06953089
Start: 2025-07-18End: 2030-06-30Target: 492Updated: 2026-02-06
A Phase II, multisite, open-label, single arm trial of BNT327 in combination with docetaxel in second-line stage IV or recurrent non-small cell lung cancer (NSCLC) following chemoimmunotherapy
Not yet recruitingCTIS2024-518279-80-00
Target: 10Updated: 2025-07-29
Phase 3
A Phase III, multisite, double-blinded randomized trial of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/carboplatin) in participants with first-line extensive-stage small-cell lung cancer
Not yet recruitingCTIS2024-515765-34-00
Target: 166Updated: 2026-01-08
A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD(L)1 therapy based on PD-L1 negative disease
Not yet recruitingCTIS2025-521884-12-00
Target: 95Updated: 2026-03-05