Printed from Voxsanity (voxsanity.com.au) — NCT07070232 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Rare Disease Trial, Recruiting
NCT07070232
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- Adults aged 18 or older at the time of signing the consent form (or older if local laws require a higher age of consent).
- People whose cancer has been confirmed by lab testing of a tissue or cell sample, and whose disease has either spread to other parts of the body or has come back after earlier treatment.
- People whose cancer can be measured on scans using a standard set of measurement rules (called RECIST v1.1).
- People who are able to provide a stored or newly collected tumour tissue sample preserved in a specific way (FFPE format) for testing.
- People who are generally well enough to carry out light activity and care for themselves, rated 0 or 1 on a standard health scale used in cancer trials (ECOG performance status).
- People whose kidneys, liver, blood cells, and other organs are working well enough, confirmed by blood tests done within 7 days before joining the trial.
- Cohort 1A (skin melanoma): People with confirmed advanced or metastatic skin melanoma that cannot be surgically removed or treated with local therapies, who have already received a specific type of immunotherapy (a PD-1 or PD-L1 inhibitor), and — if their melanoma has a BRAF gene mutation — have also previously received a BRAF-targeting treatment if that was available and appropriate, and whose disease has since worsened or who had to stop prior treatment due to side effects.
- Cohorts 1B and 1C (lung cancer): People with advanced non-small cell lung cancer (NSCLC) that has spread or cannot be removed, including both the squamous and non-squamous types.
- Cohort 1B (lung cancer, no specific gene changes): People with advanced NSCLC who do not have specific gene changes that would make them suitable for targeted drug treatments, who have already received between 1 and 3 rounds of standard treatments (which may include chemotherapy and/or immunotherapy), and whose disease has worsened or who had to stop treatment due to side effects.
- Cohort 1C (lung cancer with EGFR mutation): People with advanced NSCLC who have a confirmed specific change in the EGFR gene (Exon 21-L858R or Exon 19 deletion), who have received one or two prior treatment courses including at least one EGFR-targeted drug (with a third-generation EGFR drug required unless not approved locally), and whose disease has worsened or who had to stop treatment due to side effects.
- Cohort 1D (acral, uveal, or mucosal melanoma): People with confirmed advanced melanoma of the hands/feet (acral), eye (uveal), or mucous membranes (mucosal) that cannot be surgically removed or treated locally, who have previously received appropriate immunotherapy or, for certain uveal melanoma patients, a specific targeted therapy called tebentafusp-tebn, and whose disease has since worsened or who had to stop treatment due to side effects.
- Cohorts 1E and 1F (various solid tumours — drug interaction study): People with confirmed advanced solid tumours that cannot be cured or removed, including cancers of the bile ducts or gallbladder, liver (hepatocellular carcinoma), kidney, uterine lining, pancreas, certain well-differentiated neuroendocrine tumours, or lung cancer (Cohort 1F only), who have received between one and three prior lines of treatment (or fewer in specific cases) and whose disease has worsened or who had to stop treatment due to side effects.
- Cohort 2A (skin melanoma): People with confirmed advanced or metastatic skin melanoma that cannot be surgically removed or treated locally.
- Cohort 2B (breast cancer): People with confirmed advanced or returning breast cancer that has been tested and confirmed as HER2-negative and either hormone receptor-negative or hormone receptor-positive, according to recognised clinical guidelines.
- Cohort 2D (stomach or gastro-oesophageal junction cancer): People with confirmed advanced stomach cancer or cancer at the junction of the stomach and oesophagus (excluding oesophageal squamous cell cancer), who have received one or more prior treatments for advanced disease, including those whose tumour shows HER2 expression and who have received a HER2-targeted therapy.
- Cohort 2E (bowel cancer): People with confirmed advanced or returning colorectal cancer that cannot be removed, who have received between one and three prior standard treatment courses for advanced disease.
- Cohorts 1G and 2F (cervical cancer): People with confirmed advanced or returning cervical cancer of specific cell types (squamous, adenocarcinoma, or adenosquamous), who have previously received platinum-based chemotherapy with or without immunotherapy and/or bevacizumab, unless the treating doctor considered those treatments unsuitable.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have previously had a serious reaction or intolerance to a type of drug called a topoisomerase I inhibitor (such as topotecan, irinotecan, or deruxtecan), including severe diarrhoea as a side effect.
- People with serious ongoing health conditions that could make trial participation unsafe or difficult, including: active uncontrolled bleeding, active infection, moderate-to-severe liver scarring (Child-Pugh class B or C), significant lung disease affecting breathing, certain cancer-related emergencies, uncontrolled psychiatric conditions or substance use issues, or ongoing severe bowel inflammation (infectious colitis) that has not settled within the past 3 months.
- People whose heart pumping function (measured as left ventricular ejection fraction) is below 50%, as confirmed by a heart scan done within 28 days before joining the trial.
- People with uncontrolled fluid build-up around the lungs, in the abdomen, or around the heart that has needed drainage or other procedures within the 2 weeks before joining the trial.
- People who have a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment, who currently have this condition, or where this condition cannot be ruled out on screening scans (minor changes from prior radiation or chemotherapy may be acceptable — confirm with trial site).
- People who are pregnant, breastfeeding, or planning to become pregnant within approximately 7.5 months after the last dose of one study drug (BNT326) or within 6 months after the last dose of the other study drug (BNT327), whichever is the longer period.
- Males who are able to father children and are planning to do so during the trial or within approximately 4.5 months after the last dose of BNT326, or within 6 months after the last dose of BNT327, whichever is the longer period.
- People who are currently restricted from joining other research studies due to an exclusion period from a previous trial.
- People with a significant risk of bleeding or major blood clotting problems, as specified in the trial protocol (specific to the study drug BNT327 — confirm details with trial site).
- People who have previously had a serious reaction or intolerance to anti-angiogenic or immunotherapy drugs such as bevacizumab, ramucirumab, atezolizumab, pembrolizumab, nivolumab, or similar treatments (specific to the study drug BNT327).
- Cohort 1E only: People whose liver cancer has been identified as a specific rare subtype (fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC).
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.
Contact this trial
Principal Investigator: BioNTech Responsible Person, BioNTech SE
Phone: +49 6131 9084
Australian sites
Blacktown Hospital, Blacktown, New South Wales
St Vincent's Hospital Sydney, Darlinghurst, New South Wales
Melanoma Institute Australia, Wollstonecraft, New South Wales
Tasman Oncology Research Ltd, Southport, Queensland
Cancer Research SA, Adelaide, South Australia
Peninsula and South Eastern Haematology & Oncology Group, Frankston, Victoria
Austin Health, Heidelberg, Victoria
The Alfred Hospital, Melbourne, Victoria
One Clinical Research Pty Ltd, Nedlands, Western Australia
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
12 August 2025
Est. completion
1 March 2028
Where this trial is recruiting
🇦🇺 Australia
🇧🇪 Belgium
🇩🇪 Germany
🇮🇹 Italy
🇪🇸 Spain
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), treatment emergent serious adverse events (TESAEs), and treatment related serious adverse events (TRSAEs); Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs; Parts 1 and 2 - All cohorts except Cohort 1F - Confirmed overall response rate (ORR); Part 2 - Occurrence of dose limiting toxicities (DLTs); Part 1 - Cohort 1F (DDI) only - PK assessment: Maximum concentration...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 18 August 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.