NCT04683939 is a Phase 1, PHASE2 clinical trial of BNT141 in Solid Tumor, sponsored by BioNTech SE.

Who is sponsoring NCT04683939?

NCT04683939 is sponsored by BioNTech SE.

What drugs are being tested in NCT04683939?

Interventions in NCT04683939: BNT141, Nab-paclitaxel, Gemcitabine.

What condition does NCT04683939 study?

NCT04683939 studies Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Pancreatic Cancer, Biliary Tract Cancer, Cholangiocarcinoma, Metastatic Cancer.

Is NCT04683939 still recruiting?

NCT04683939 is currently terminated. Last updated 2 October 2024.

Are results published for NCT04683939?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-02 · How we verify

NCT04683939

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors

Terminated Phase 1, PHASE2 Results posted Last updated 2 October 2024

What this trial tests

Phase 1, PHASE2 trial testing BNT141 in Solid Tumor in 13 participants. Terminated before completion.

Timeline

18 January 2022

Primary endpoint
24 July 2023

24 July 2023

Quick facts

Lead sponsor	BioNTech SE
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	18 January 2022
Primary completion	24 July 2023
Estimated completion	24 July 2023
Sites	7 locations across Canada, United States

Drugs / interventions tested

BNT141 — full drug profile →
Nab-paclitaxel (nab-paclitaxel) — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →
Gastric Cancer — all drugs for Gastric Cancer →
Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →
Esophageal Adenocarcinoma — all drugs for Esophageal Adenocarcinoma →

Sponsor

BioNTech SE — full company profile →

Who can join

18 and older, any sex, with Solid Tumor or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Occurrence of Treatment-emergent Adverse Events (TEAEs) Within a Patient Including Grade ≥ 3, Serious, Fatal TEAE by Relationship Primary · From start of BNT141 treatment until the second Safety Follow-up Visit (60 ± 7 days after last dose), up to 30 weeks.

All TEAEs are included, i.e., AEs with an onset date on or after the first dose of BNT141 (if the AE was absent before the first dose) or worsened after the first dose of BNT141 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT141 are included only if assessed as related to BNT141 by the investigator. Intensity of AEs was graded according to the NCI CTCAE v5.0, i.e.,: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening consequences; urgent urgent intervention indicated, Grade 5 - Death related to AE

Any TEAE

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	3
BNT141 Monotherapy - 0.30 mg/kg	3
BNT141 Monotherapy - 0.45 mg/kg	4
BNT141 Monotherapy - 0.60 mg/kg	3

Related TEAE

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	3
BNT141 Monotherapy - 0.30 mg/kg	3
BNT141 Monotherapy - 0.45 mg/kg	4
BNT141 Monotherapy - 0.60 mg/kg	3

Grade ≥3 TEAE

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	2
BNT141 Monotherapy - 0.45 mg/kg	2
BNT141 Monotherapy - 0.60 mg/kg	1

Related Grade ≥3 TEAE

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	0
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	1

Any serious TEAE

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	1
BNT141 Monotherapy - 0.30 mg/kg	1
BNT141 Monotherapy - 0.45 mg/kg	1
BNT141 Monotherapy - 0.60 mg/kg	2

Related serious TEAE

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	1
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	1

TEAE of special interest

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	1
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	0

TEAE leading to death

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	0
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	0

Occurrence of Dose Reductions and Discontinuation of BNT141 Due to TEAEs Primary · From start of BNT141 treatment until the second Safety Follow-up Visit (60 ± 7 days after last dose), up to 30 weeks.

TEAE leading to treatment discontinuation

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	0
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	0

Related TEAE leading to treatment discontinuation

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	0
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	0

TEAE leading to study drug interruption

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	2
BNT141 Monotherapy - 0.45 mg/kg	1
BNT141 Monotherapy - 0.60 mg/kg	1

Related TEAE leading to study drug interruption

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	2
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	1

TEAE leading to dose reduction

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	0
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	0

Related TEAE leading to dose reduction

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	0
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	0

TEAE leading to dose rate reduction

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	0
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	0

Related TEAE leading to dose rate reduction

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	0
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	0

Occurrence of Dose-limiting Toxicities (DLTs) Within a Patient During the DLT Evaluation Period Primary · First treatment cycle (From first dose up to 21 days after first dose)

Serious AEs, non-serious Grade ≥ 3 non-hematological and hematological AEs as defined per DLT criteria and clinically significant abnormal laboratory values Grade ≥ 3 were collected and considered a DLT if assessed by the investigator to be at least possibly related to BNT141. Toxicities clearly not related to BNT141 (e.g., progressive disease, comorbidity, etc.) were not considered a DLT. The NCI CTCAE v.5.0 was used to grade the intensity of AEs.

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0
BNT141 Monotherapy - 0.30 mg/kg	0
BNT141 Monotherapy - 0.45 mg/kg	0
BNT141 Monotherapy - 0.60 mg/kg	0

RiboMab PK Parameter - Area Under the Concentration Time Curve (AUC) Secondary · First treatment cycle (From first dose up to 21 days after first dose)

Intact RiboMab (full-length and fully assembled antibody) PK serum samples were collected and analyzed. AUC (0-tau), AUC (0-inf) and AUC (0-504) were estimated from serum concentration data from Cycle 1 using non-compartmental analysis. AUC (0-inf): Area under the drug concentration-time curve, from time zero to infinity. AUC (0-504): Area under the drug concentration-time curve, from time zero to 504 hours after the start of the infusion. AUC (0-tau): Area under the drug concentration-time curve, from time zero over the dosing interval at steady-state (Tau = 504 hours corresponding to 3-w

AUC (0-tau)

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	1613407.9486	± 50
BNT141 Monotherapy - 0.30 mg/kg	5798293.4278	± 30
BNT141 Monotherapy - 0.45 mg/kg	5499389.8684	± 40
BNT141 Monotherapy - 0.60 mg/kg	5244472.7649	± 60

AUC (0-inf)

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	2166227.7262	± 50
BNT141 Monotherapy - 0.30 mg/kg	9838894.4371	± 50
BNT141 Monotherapy - 0.45 mg/kg	9128700.3987	± 50
BNT141 Monotherapy - 0.60 mg/kg	6739801.3745	± 50

AUC (0-504)

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	1615489.8795	± 50
BNT141 Monotherapy - 0.30 mg/kg	5736526.2444	± 30
BNT141 Monotherapy - 0.45 mg/kg	6253473.9330	± 40
BNT141 Monotherapy - 0.60 mg/kg	5283854.6455	± 60

RiboMab PK Parameter - Clearance Secondary · First treatment cycle (From first dose up to 21 days after first dose)

Intact RiboMab (full-length and fully assembled antibody) PK serum samples were collected and analyzed. Clearance was estimated from serum concentration from Cycle 1 data using non-compartmental analysis.

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	0.0065	± 60
BNT141 Monotherapy - 0.30 mg/kg	0.0021	± 40
BNT141 Monotherapy - 0.45 mg/kg	0.0036	± 50
BNT141 Monotherapy - 0.60 mg/kg	0.0066	± 70

RiboMab PK Parameter - Volume of Distribution at Steady State (Vss) Secondary · First treatment cycle (From first dose up to 21 days after first dose)

Intact RiboMab (full-length and fully assembled antibody) PK serum samples were collected and analyzed. Volume of distribution at steady state (Vss) was estimated as mean residence time calculated using last measured concentration (MRT inf) \* CL.

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	2.2103	± 70
BNT141 Monotherapy - 0.30 mg/kg	1.1099	± 40
BNT141 Monotherapy - 0.45 mg/kg	1.5656	± 20
BNT141 Monotherapy - 0.60 mg/kg	2.0340	± 80

RiboMab PK Parameter - Maximum Serum Drug Concentration (Cmax) Secondary · First treatment cycle (From first dose up to 21 days after first dose)

Intact RiboMab (full-length and fully assembled antibody) PK serum samples were collected and analyzed. Cmax was estimated from serum concentration from Cycle 1 data using non-compartmental analysis.

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	5844.7265	± 60
BNT141 Monotherapy - 0.30 mg/kg	17829.5955	± 40
BNT141 Monotherapy - 0.45 mg/kg	24001.7233	± 40
BNT141 Monotherapy - 0.60 mg/kg	19801.0462	± 60

RiboMab PK Parameter - Time to Reach Cmax (Tmax) Secondary · First treatment cycle (From first dose up to 21 days after first dose)

Intact RiboMab (full-length and fully assembled antibody) PK serum samples were collected and analyzed. Tmax was estimated from serum concentration from Cycle 1 data using non-compartmental analysis.

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	59.80362	± 20
BNT141 Monotherapy - 0.30 mg/kg	61.02810	± 20
BNT141 Monotherapy - 0.45 mg/kg	68.18978	± 30
BNT141 Monotherapy - 0.60 mg/kg	54.72251	± 20

RiboMab PK Parameter - Concentration at the End of a Dosing Interval (Taken Directly Before Next Administration) (Ctrough) Secondary · Before start of Cycle 3 (plasma sample taken directly before BNT141 Cycle 3 administration)

Intact RiboMab (full-length and fully assembled antibody) PK serum samples were collected and analyzed. Ctrough was estimated from serum concentration from Cycle 1 data using non-compartmental analysis. Ctrough values are available for participants treated with dose level 1 and dose level 2 only.

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	3516.7500	± NA
BNT141 Monotherapy - 0.30 mg/kg	3734.1225	± 50

RiboMab PK Parameter - Half-time (t½) Secondary · First treatment cycle (From first dose up to 21 days after first dose)

Intact RiboMab (full-length and fully assembled antibody) PK serum samples were collected and analyzed. T½ was estimated from serum concentration from Cycle 1 data using non-compartmental analysis.

Group	Value	95% CI
BNT141 Monotherapy - 0.15 mg/kg	236.9571	± 10
BNT141 Monotherapy - 0.30 mg/kg	366.7979	± 50
BNT141 Monotherapy - 0.45 mg/kg	304.9024	± 30
BNT141 Monotherapy - 0.60 mg/kg	214.7214	± 10

Adverse events — posted to ClinicalTrials.gov

Time frame: Deaths and SAEs: All events from the signing of the trial-specific informed consent from until the second Safety Follow-up Visit, up to 33 weeks. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until the second Safety Follow-up Visit, up to 30 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BNT141 Monotherapy - 0.15 mg/kg

Serious: 1/3 (33%)

Deaths: 1/3

BNT141 Monotherapy - 0.30 mg/kg

Serious: 1/3 (33%)

Deaths: 1/3

BNT141 Monotherapy - 0.45 mg/kg

Serious: 1/4 (25%)

Deaths: 2/4

BNT141 Monotherapy - 0.60 mg/kg

Serious: 2/3 (67%)

Deaths: 1/3

Serious adverse events (4 terms)

Reaction	System	BNT141 Monotherapy - 0.15 …	BNT141 Monotherapy - 0.30 …	BNT141 Monotherapy - 0.45 …	BNT141 Monotherapy - 0.60 …
Cytokine release syndrome	Immune system disorders	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—
Enterococcal bacteraemia	Infections and infestations	—	—	—	—
Embolism	Vascular disorders	—	—	—	—

Other adverse events (52 terms — click to expand)

Reaction	System	BNT141 Monotherapy - 0.15 …	BNT141 Monotherapy - 0.30 …	BNT141 Monotherapy - 0.45 …	BNT141 Monotherapy - 0.60 …
Vomiting	Gastrointestinal disorders	—	—	—	—
Cytokine release syndrome	Immune system disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Lymph node pain	Blood and lymphatic system disorders	—	—	—	—
Lymphocytosis	Blood and lymphatic system disorders	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Faeces discoloured	Gastrointestinal disorders	—	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—	—
Obstruction gastric	Gastrointestinal disorders	—	—	—	—
Drug intolerance	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—
Weight decreased	Investigations	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness postural	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—

Most-reported serious reactions: Cytokine release syndrome, Bacteraemia, Enterococcal bacteraemia, Embolism.

Data from ClinicalTrials.gov NCT04683939 adverse events section.

Sponsor's own description

This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors. The sponsor decided to stop the development of BNT141 on 24 July 2023 and the study was terminated early.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Claudin18.2 is a novel molecular biomarker for tumor-targeted immunotherapy.
Cao W, Xing H, Li Y, Tian W, et al · · 2022 · cited 127× · PMID 35642043 · DOI 10.1186/s40364-022-00385-1
Recent Advancement in mRNA Vaccine Development and Applications.
Al Fayez N, Nassar MS, Alshehri AA, Alnefaie MK, et al · · 2023 · cited 95× · PMID 37514158 · DOI 10.3390/pharmaceutics15071972
mRNA-based vaccines and therapeutics: an in-depth survey of current and upcoming clinical applications.
Wang YS, Kumari M, Chen GH, Hong MH, et al · · 2023 · cited 93× · PMID 37805495 · DOI 10.1186/s12929-023-00977-5
mRNA nanomedicine: Design and recent applications.
Kubiatowicz LJ, Mohapatra A, Krishnan N, Fang RH, et al · · 2022 · cited 88× · PMID 36249890 · DOI 10.1002/exp.20210217
Progress and prospects of mRNA-based drugs in pre-clinical and clinical applications.
Shi Y, Shi M, Wang Y, You J. · · 2024 · cited 67× · PMID 39543114 · DOI 10.1038/s41392-024-02002-z
Targeting CLDN18.2 in cancers of the gastrointestinal tract: New drugs and new indications.
Chen J, Xu Z, Hu C, Zhang S, et al · · 2023 · cited 49× · PMID 36969060 · DOI 10.3389/fonc.2023.1132319
Targeted Cancer Immunotherapy: Nanoformulation Engineering and Clinical Translation.
Yu M, Yang W, Yue W, Chen Y. · · 2022 · cited 35× · PMID 36257824 · DOI 10.1002/advs.202204335
mRNA-Based Therapeutics in Cancer Treatment.
Sun H, Zhang Y, Wang G, Yang W, et al · · 2023 · cited 33× · PMID 36839944 · DOI 10.3390/pharmaceutics15020622

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04683939 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioNTech SE
Last refreshed: 2 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04683939.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04683939

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Solid Tumor

Other BioNTech SE trials

Verify against primary sources