interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
43873
clinical trials with a EudraCT protocol, of which
7294
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
Frequently Asked Questions ).
3 result(s) found for: BioNTech.
Displaying page 1 of 1.
EudraCT Number: 2019-003593-17
Sponsor Protocol Number: BNT411-01
Start Date*: 2021-02-18
Sponsor Name:BioNTech SE
Full Title: Phase 1/2a, first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT411 as a monotherapy in p...
Medical condition: Chemotherapy-naïve extensive-stage small cell lung cancer
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10041068
Small cell lung cancer extensive stage
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10049280
Solid tumour
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:DE(Completed)ES(Prematurely Ended)GB(GB - no longer in EU/EEA)
Trial results:(No results available)
EudraCT Number: 2018-004321-86
Sponsor Protocol Number: RN5609C00
Start Date*: 2019-07-24
Sponsor Name:BioNTech SE
Full Title: First-in-human, dose titration and expansion trial to evaluate safety, immunogenicity and preliminary efficacy of W_pro1 (BNT112) monotherapy
and in combination with cemiplimab in patients with pr...
Medical condition: Male adults with prostate cancer, both mCRPC (Arms 1A & 1B) and LPC (ARms 2&3) patients, will be treated with W_pro1 alone or in combination with cemiplimab. LPC patients will also receive neo-adju...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10007113
Cancer of prostate
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10036909
Prostate cancer metastatic
PT
Population Age: Adults, Elderly
Gender: Male
Trial protocol:GB(GB - no longer in EU/EEA)HU(Prematurely Ended)DE(Prematurely Ended)
Trial results:(No results available)
EudraCT Number: 2019-004323-20
Sponsor Protocol Number: BNT211-01
Start Date*: 2020-06-30
Sponsor Name:BioNTech Cell & Gene Therapies GmbH
Full Title: Phase 1/2a, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6 RNA-LPX in patients with CLDN6-...
Medical condition: CLDN6-positive relapsed or refractory advanced solid tumors
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10043302
Testicular cancer
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10033128
Ovarian cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10017758
Gastric cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10046766
Uterine cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10007460
Carcinoma of unknown primary
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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• EEA CTAs: Date study was authorised to proceed • Outside EU/EEA: Date study was submitted in EudraCT