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Priya Life Science Compound trial record
Compound · clinical trials

Gotistobart clinical trials

Also listed in trial records as BNT316, ONC-392, ONC-392 low, ONC-392 high
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 6 trials in our USA, Australia, UK, Germany, Spain, Turkey, Poland, China, Italy, Netherlands, Belgium, Canada, Japan, South Korea, Mexico and Egypt registers that name Gotistobart as an intervention. Synced 9 Nov 2026
6Current trials
1Recruiting now
2Lead sponsors
16Country registers
At a glance

Gotistobart is named as an intervention in 6 current clinical trials in our USA, Australia, UK, Germany, Spain, Turkey, Poland, China, Italy, Netherlands, Belgium, Canada, Japan, South Korea, Mexico and Egypt registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is OncoC4, Inc (5). The most-studied condition is Non Small Cell Lung Cancer.

How Gotistobart works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Non-small cell lung carcinomaPhase 3

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL5314987, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Gotistobart

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting117%
  • Active, closed467%
  • By invitation117%

Trials by phase

  • Phase 3233%
  • Phase 1/2233%
  • Phase 1117%
  • Phase 2117%
01

Clinical trials of Gotistobart

6 trials
StudyPhaseStatusLead sponsorRegisters
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
NCT05142189 · Non-Small Cell Lung Cancer
Phase 1 Recruiting BioNTech SE UK, USA, Germany, Spain, Poland, Turkey, Australia
Gotistobart Long Term Extension (LTE) Study
NCT07659379 · Advanced Solid Tumor
Phase 3 By invitation OncoC4, Inc USA
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
NCT05671510 · Non Small Cell Lung Cancer
Phase 3 Active, closed OncoC4, Inc UK, USA, China, Germany, Spain, Italy, Netherlands, Belgium, Turkey, Canada, Japan, South Korea, Australia
ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer
NCT05446298 · ClinicalTrials.gov ↗ · Ovarian Cancer, High Grade Serous Adenocarcinoma of Ovary, Primary Peritoneal Carcinoma
Phase 2 Active, closed OncoC4, Inc USA, Egypt
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
NCT04140526 · Non Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Melanoma
Phase 1/2 Active, closed OncoC4, Inc USA, Australia
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
NCT05682443 · Metastatic Castration-resistant Prostate Cancer
Phase 1/2 Active, closed OncoC4, Inc USA, Mexico

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Gotistobart

10 conditions
05

Related compounds

06

Questions about Gotistobart trials

How many clinical trials are testing Gotistobart?

6 current trials in our USA, Australia, UK, Germany, Spain, Turkey, Poland, China, Italy, Netherlands, Belgium, Canada, Japan, South Korea, Mexico and Egypt registers name Gotistobart (also registered as BNT316) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Gotistobart trials recruiting patients?

Yes. 1 of the 6 trials is recruiting: 1 with sites in USA, 1 with sites in Australia, 1 with sites in UK, 1 with sites in Germany, 1 with sites in Spain, 1 with sites in Turkey and 1 with sites in Poland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Gotistobart clinical trials?

OncoC4, Inc (5) and BioNTech SE (1). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Gotistobart works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Gotistobart works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Gotistobart (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.