A two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 in combination with low-dose subcutaneous interleukin-2 in patients with advanced solid tumors (EVICTION-2)

You may be able to join if

• 1) Male or female aged ≥18 years 2) Voluntarily signed written informed consent before performance of any study-related screening procedures 3) Relapsed/refractory patients who have failed at least 2 lines of systemic therapy or who failed first line therapy and are intolerant of or have a contraindication to the standard second line of therapy with histologically or cytologically confirmed diagnosis of: a. metastatic colorectal cancer (mCRC)i. patients must have progressed after receiving a fluoropyrimidine, oxaliplatin, and irinotecan and an antiangiogenic agent ii. patients with tumors known to be microsatellite instability-high (MSI-H), prior therapy with a checkpoint inhibitor is required if they were clinically able to receive it iii. patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type should have received anti-EGFR therapy. b. metastatic ovarian cancer: i. patients must be platinum resistant and must have had at least one treatment line after being resistant to platinum-based chemotherapy c. metastatic castration-resistant prostate cancer (mCRPC) d. metastatic pancreatic ductal adenocarcinoma (PDAC) e. metastatic or unresectable refractory melanoma with primary resistance following at least 6 weeks of prior CPI treatment, defined as best response of progressive disease or SD of short duration (lasting less than 6 months), as per Society for Immunotherapy of Cancer [SITC] Immunotherapy Resistance Taskforce [Kluger et al 2020]). Patients must have no available standard of care or treatment with potential survival benefit for their disease, as determined by the treating Investigator. Melanoma patients who have proto-oncogene B Raf (BRAF) V600E or V600K mutations must have received prior combination BRAF and mitogen-activated protein kinase (MEK) inhibitor therapy unless they have contraindications, as determined by the treating Investigator. 4) Availability of baseline tumor biopsy and willingness to undergo on-study tumor biopsies5) Eastern Cooperative Oncology Group (ECOG) performance status ≤1 6) Life expectancy >3 months as assessed by the Investigator 7) Clinical laboratory assessments: a. Hematology: - Hemoglobin ≥8.5 g/dL (equal to 5.28 mmol/L; transfusion dependent or independent); - platelet count ≥100 × 109/L; - lymphocyte count ≥0.5 × 109/L; - absolute neutrophil count ≥1.0 × 109/L; - White Blood Count (WBC) ≥4 × 109/L b. Liver enzymes: - aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN) (<5 × ULN in the case of liver metastases);- bilirubin ≤1.5 × ULN (<2 × ULN in case of liver metastases); c. Renal function: serum creatinine <1.5 × ULN or creatinine clearance ≥50 mL/min (Cockcroft and Gault) for serum creatinine ≥1.5x ULN. 8) Pulse oximetry of 95% or higher at rest, unless patient has chronic lung disease where 90% or higher at rest is acceptable 9) Contraceptives measures10) Women must not be breastfeeding 11) At least 1 measurable lesion per RECIST