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

Inclusion Criteria:

1. Relapsed/refractory patients who have failed at least 2 lines of systemic therapy orwho failed first line therapy and are intolerant of or have a contraindication tothe standard second line of therapy with histologically or cytologically confirmeddiagnosis of:

2. metastatic colorectal cancer (CRC):

3. metastatic ovarian cancer:

4. metastatic castration-resistant prostate cancer (mCRPC)

5. metastatic pancreatic ductal adenocarcinoma (PDAC)

6. metastatic or unresectable refractory melanoma

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

Exclusion Criteria:

1. Any malignancy of γ9δ2 T cell origin
2. Any systemic anti-tumor-directed drug therapy within 28 days or 5 timesthe elimination half-life (whichever is shorter) before study treatment
3. Treatment with investigational drugs within 28 days before study treatment
4. Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg ofdexamethasone or equivalent, for the last 28 days and ongoing
5. Patients with rapidly progressing disease defined as advanced/metastatic,symptomatic, visceral spread, with a risk of life-threateningcomplications in the short term (e.g., during Screening Period/ treatmentwashout) that includes patients with massive uncontrolled effusionspleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50%liver involvement
6. Ongoing immune-related adverse events (irAEs) ≥grade 2 not resolved fromprevious therapies except vitiligo, stable neuropathy up to grade 2, hairloss, and stable endocrinopathies with substitutive hormone therapy.
7. Ongoing systemic autoimmune disease requiring systemic immunosuppressivetherapy
8. Primary or secondary immune deficiency
9. Active and uncontrolled infections requiring intravenous antibiotic orantiviral treatment
10. Patients with contraindication to IL-2 treatment according to theSmPC/package insert