Phase 2 Parkinson's Disease Trial, Recruiting NCT07147348 Sponsor: BioNTech SE Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Recruiting

NCT07147348
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with a solid tumour (confirmed by laboratory testing of tissue or cells) that has spread locally, come back, or spread to other parts of the body, and who have already received appropriate prior treatment for their cancer type and stage, or for whom standard treatment is considered unsuitable or too difficult to tolerate.
  • People who have at least one tumour that can be measured using standard imaging methods (based on RECIST v1.1 guidelines).
  • People who are either fully active and able to carry out normal daily activities, or who are unable to do heavy physical work but are still able to walk and do light or desk-based activities (as assessed using a standard medical scale).
  • People who have a predicted life expectancy of at least 3 months.
  • People whose heart is pumping blood at 50% efficiency or better, confirmed by a heart scan done within 28 days before starting the study treatment.
  • People whose liver, kidneys, blood counts, and blood clotting levels meet the required standards.
  • People who have largely recovered from side effects of previous cancer treatments (with some specific exceptions allowed, such as hair loss, mild nerve problems, or a thyroid condition that is stable on medication).
  • People whose doctor considers it medically acceptable to stop certain other cancer treatments and medications for the required period before joining the trial.
  • For specific parts of the trial (Parts B and D only): People who have been diagnosed with particular cancer types specified by the trial (confirm with trial site).

Who may not be able to join:

  • People who have an active infection (such as a serious bacterial or fungal infection, severe pneumonia, or blood infection) that requires treatment with medicines given into the bloodstream or by injection (oral antibiotics may be acceptable — confirm with trial site).
  • People whose cancer originated in the brain or spinal cord (primary central nervous system cancer).
  • People who have active brain or spinal cord metastases that are untreated and causing symptoms, or that require steroid or anti-seizure medication to manage symptoms.
  • People who have had fluid build-up around the lungs or in the abdomen that needed to be drained by a medical procedure within the 14 days before starting the study treatment.
  • People who have, or have had in the past, lung inflammation (pneumonitis) that required steroid treatment, or a chronic scarring lung condition (interstitial lung disease).
  • People with significant existing lung complications.
  • People who have a history of serious heart disease.
  • People who have had severe blood-related side effects from previous cancer treatments, such as serious drops in white blood cell counts with fever (as assessed by their doctor).
  • People who have active or ongoing eye conditions affecting the cornea (the clear front surface of the eye), or any eye disease that would make it difficult to monitor for drug-related eye effects.
  • People who have high blood pressure that is not controlled despite taking blood pressure medication, or diabetes that is poorly controlled.
  • People who have been diagnosed with another cancer within the past 5 years (exceptions may apply for certain types of skin cancer or fully removed early-stage cancers — confirm with trial site).
  • People who have an unstable blood clot condition, such as a clot in a deep vein, an artery, or the lungs.
  • People who still have unresolved side effects from previous cancer treatment that are rated above a mild level (with some exceptions such as hair loss or stable thyroid conditions on medication).
  • For specific parts of the trial (Parts C and D only): People who have previously been treated with a combination of certain immunotherapy and anti-tumour blood vessel drugs (PD-1/L1 and VEGF-A antibody combinations, including certain dual-action antibodies).
  • For specific parts of the trial (Parts C and D only): People who have an active or past autoimmune disease that could worsen with immunotherapy, or who have a weakened immune system due to an organ or stem cell transplant (some exceptions may apply — confirm with trial site).
  • For specific parts of the trial (Parts C and D only): People who have wounds, ulcers, or bone fractures that are not healing properly.
  • For specific parts of the trial (Parts C and D only): People who have major blood clotting disorders or a significant risk of serious bleeding.
  • For specific parts of the trial (Parts C and D only): People who had a serious immune-related side effect from a previous immunotherapy that caused them to stop that treatment.
  • For specific parts of the trial (Parts C and D only): People who were hospitalised for a bowel blockage within the 3 months before starting the study treatment.
  • For specific parts of the trial (Parts C and D only): People who have recently taken blood-thinning medication (other than a specific type called low molecular weight heparin) within 14 days, or certain blood platelet-reducing drugs within 10 days, before starting the study treatment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: BioNTech Responsible Person, BioNTech SE

Phone: +49 6131 9084

Australian sites

Cancer Research SA, Adelaide,
Monash Medical Centre, Clayton,
Peter MacCallum Cancer Centre, Melbourne,
The Alfred Hospital, Melbourne,
One Clinical Research, Nedlands,
Scientia Clinical Research Limited, Randwick,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
BioNTech SE
Registry
ClinicalTrials.gov
Start date
27 August 2025
Est. completion
1 November 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Parts A and C - Occurrence of dose limiting toxicities (DLTs) within a participant during the DLT observation period; All parts - Percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship; Parts A and C - Percentage of participants with dose interruptions or discontinuations of study treatment due to TEAEs; Parts B and D - Percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs; Parts B and D (expansion cohorts) - Objective response rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov