NCT07070232
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.
Trial details
Where this trial is recruiting
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?
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.