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NCT07070232

NCT07070232
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be 18 years of age or older at the time you give your consent to join (or older if required by local law).
  • Your cancer must have been confirmed by a tissue or cell sample (biopsy) and must be at an advanced stage — either spread to other parts of the body or returned after previous treatment.
  • Your cancer must be measurable on a scan using standard medical guidelines.
  • You must be able to provide a stored or freshly collected tumor tissue sample.
  • You must be reasonably active and able to care for yourself — able to do light activity but not heavy physical work (this is measured on a standard scale called ECOG, scores 0 or 1).
  • Your heart, liver, kidneys, and blood counts must be working well enough, as checked by blood tests done within 7 days before joining.
  • For skin (cutaneous) melanoma (Cohort 1A): Your melanoma cannot be removed by surgery or treated with local therapy, and you must have already received a specific type of immunotherapy (a PD-1 or PD-L1 inhibitor); if your melanoma has a BRAF gene change, you must also have received a specific targeted treatment for that, if it was available and appropriate for you.
  • For non-small cell lung cancer without specific gene changes (Cohort 1B): Your lung cancer must be advanced and must not have certain gene changes that have approved targeted treatments; you must have already received 1 to 3 prior treatment regimens including chemotherapy and/or immunotherapy.
  • For non-small cell lung cancer with an EGFR gene change (Cohort 1C): Your lung cancer must have a confirmed EGFR mutation (specifically L858R or 19del), and you must have received one or two prior treatments including at least one third-generation EGFR-targeted drug (if available in your country).
  • For acral, uveal, or mucosal melanoma (Cohort 1D): Your melanoma cannot be removed by surgery or treated with local therapy, and you must have previously received appropriate available treatments as recommended in your country.
  • For certain solid tumors in the drug interaction study (Cohorts 1E and 1F): Your cancer must be one of the following — bile duct cancer, liver cancer (hepatocellular carcinoma), kidney cancer, uterine cancer (excluding true sarcomas), pancreatic cancer, certain neuroendocrine tumors, or non-small cell lung cancer (Cohort 1F only) — and you must have already received between one and three prior treatments.
  • For cutaneous melanoma (Cohort 2A): Your melanoma must be confirmed as unresectable or metastatic and cannot be treated with local therapy.
  • For breast cancer (Cohort 2B): Your breast cancer must be confirmed as advanced or metastatic, HER2-negative, and either hormone receptor-negative or hormone receptor-positive.
  • For stomach or gastroesophageal junction cancer (Cohort 2D): Your cancer must be confirmed as advanced adenocarcinoma or squamous carcinoma of the stomach or where the stomach meets the food pipe (note: cancer of the food pipe itself is not included); you must have received one or more prior treatments depending on which sub-group applies to you.
  • For colorectal cancer (Cohort 2E): Your cancer must be confirmed as advanced or metastatic colorectal adenocarcinoma, and you must have received between one and three prior treatment regimens.
  • For cervical cancer (Cohorts 1G and 2F): Your cancer must be confirmed as advanced or metastatic cervical cancer of specific cell types, and you must have received platinum-based chemotherapy (with or without other agents), unless your doctor determined you were not a suitable candidate.

Who may not be able to join:

  • You have had a severe reaction or intolerance to a type of chemotherapy drug called a topoisomerase I inhibitor (such as topotecan, irinotecan, or deruxtecan), for example severe diarrhoea.
  • You have another serious illness that is not well controlled and could interfere with the study or put you at risk — this includes active bleeding problems, active infection, serious liver scarring (Child-Pugh class

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

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.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
BioNTech SE
Registry
clinicaltrials_gov
Start date
12 August 2025
Est. completion
1 February 2028

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇩🇪 Germany 🇮🇹 Italy 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

8 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?

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov