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BNT327

DRUG16 trials

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
DualityBio Inc.Advanced Solid Tumor
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
BioNTech SELocally Advanced Breast Cancer, Metastatic Breast Cancer, Unresectable Breast Carcinoma
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
BioNTech SEAdvanced Lung Cancer
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
BioNTech SEMetastatic Colorectal Cancer
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
BioNTech SENon-small Cell Lung Cancer
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
BioNTech SEAdvanced Solid Tumor
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
BioNTech SEAdvanced solid tumors
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
BioNTech SEMetastatic colorectal cancer
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
BioNTech SEAdvanced Breast Cancer Metastatic Breast Cancer
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
BioNTech SENon-small Cell Lung Cancer
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
BioNTech SEAdvanced Lung Cancer
Target: 26Updated: 2026-02-24

Phase 2

Phase 3

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