Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

Inclusion Criteria

• •1. Age \> 18 years old
• •2. Have progressed after ≥ 1, but no more than 3 regimens of systemic therapies for recurrent / metastatic disease.
• •3. Subjects must have measurable disease.
• •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •1\. Histological or cytological confirmation of advanced solid malignancy that is refractory to or not a candidate for current standard treatment(s) and for whom no standard therapy is available.
• •1. Histological or cytological confirmation of one of the advanced cancers listed below;
• •* NSCLC
• •* SCLC
• •* cutaneous melanoma
• •* Merkel cell carcinoma
• •* squamous cell carcinoma of head and neck, anal canal, or skin
• •* urothelial cancer
• •* clear cell or non-clear cell renal cell carcinoma
• •* triple negative breast cancer
• •* endometrial cancer (regardless of MSI status)
• •* cervical cancer
• •* gastroesophageal cancer
• •* hepatocellular cancer
• •* any histology if known to be microsatellite-instability high (MSI-H)
• •2. Tumors must be refractory to or not a candidate for current standard treatment(s) and for whom no standard therapy exists.
• •1. Histological or cytological confirmation of one of the advanced cancers listed below;
• •* NSCLC cancer any histology
• •* SCLC
• •* cutaneous melanoma
• •* Merkel cell carcinoma
• •* squamous cell carcinoma of head and neck, anal canal, or skin
• •* urothelial cancer
• •* clear cell or non-clear cell renal cell carcinoma
• •* triple negative breast cancer
• •* endometrial cancer (regardless of MSI status)
• •* cervical cancer
• •* gastroesophageal cancer
• •* hepatocellular
• •* any histology if known to be microsatellite-instability high (MSI-H)
• •2. Tumors must be refractory to or subjects intolerant of current standard treatment(s) and for whom no standard therapies are available.
• •3. Optional biopsies: Subjects that consent to optional fresh tumor biopsies must have at least one non-target soft tissue tumor lesion that can be biopsied.
• •1. Subjects must be deemed eligible by the Investigator to receive pembrolizumab.
• •2. Histological or cytological confirmation of one of the advanced cancers listed below (list may vary in each country, USA shown here);
• •* NSCLC cancer any histology
• •* SCLC
• •* cutaneous melanoma
• •* Merkel cell carcinoma
• •* squamous cell carcinoma of head and neck, anal canal, or skin
• •* urothelial cancer
• •* clear cell or non-clear cell renal cell carcinoma
• •* triple negative breast cancer
• •* endometrial cancer (regardless of MSI status)
• •* cervical cancer
• •* gastroesophageal cancer
• •* hepatocellular cancer
• •* any histology if known to be microsatellite-instability high (MSI-H)
• •Tumors must be refractory to or subjects intolerant of current standard treatment(s) or for whom no standard therapy is available.
• •1. Subjects must be deemed eligible by the Investigator to receive pembrolizumab
• •2. Histological or cytological confirmation of one of the advanced cancers listed below (list may vary in each country, USA shown here);
• •* non-small cell lung cancer any histology
• •* SCLC
• •* cutaneous melanoma
• •* Merkel Cell carcinoma
• •* squamous cell carcinoma of head and neck, anal canal, or skin
• •* urothelial cancer
• •* clear cell or non-clear cell renal cell carcinoma
• •* triple negative breast cancer
• •* endometrial cancer (regardless of MSI status)
• •* gastroesophageal cancer
• •* hepatocellular cancer
• •* any histology if known to be microsatellite-instability high (MSI-H)
• •3. Tumors must be refractory to or subjects intolerant of current standard non-IO treatment(s) or for whom no standard therapy is available.