Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors

Inclusion criteria

• 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:

• metastatic colorectal cancer (CRC):
• metastatic ovarian cancer:
• metastatic castration-resistant prostate cancer (mCRPC)
• metastatic pancreatic ductal adenocarcinoma (PDAC)
• metastatic or unresectable refractory melanoma

• Availability of baseline tumor biopsy and willingness to undergo on-study tumor biopsies 3) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 4) Life expectancy > 3 months as assessed by the Investigator 5) At least 1 measurable lesion per RECIST1.1

Exclusion criteria

• Any malignancy of γ9δ2 T cell origin
• Any systemic anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment
• Treatment with investigational drugs within 28 days before study treatment
• Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of dexamethasone or equivalent, for the last 28 days and ongoing
• Patients with rapidly progressing disease defined as advanced/metastatic, symptomatic, visceral spread, with a risk of life-threatening complications in the short term (e.g., during Screening Period/ treatment washout) that includes patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement
• Ongoing immune-related adverse events (irAEs) ≥grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
• Ongoing systemic autoimmune disease requiring systemic immunosuppressive therapy
• Primary or secondary immune deficiency
• Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
• Patients with contraindication to IL-2 treatment according to the SmPC/package insert