GEN1042 Safety Trial in Subjects With Malignant Solid Tumors

Inclusion Criteria:

Dose Escalation:

• Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.

Expansion:

• Histologically or cytologically confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC who are not anymore candidates for standard therapy

Dose Escalation and Expansion:

• Measurable disease according to RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) 0-1
• Acceptable bone marrow and hematological, liver and renal functions
• Acceptable coagulation status

Exclusion Criteria:

Uncontrolled intercurrent illness, including but not limited to:

• Ongoing or active infection treated with intravenous anti-infective therapy less than 2 weeks prior to first dose
• Symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
• Uncontrolled hypertension despite optimal medical management.
• Evidence of significant autoimmune disease suggesting risk for immune-related adverse events (irAEs).
• History of irAEs that led to treatment discontinuation of prior ICP inhibitor
• • History of chronic liver disease or evidence of hepatic cirrhosis.
• History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
• History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1042.
• Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
• Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.

Prior therapy:

• Radiotherapy within 14 days prior to first GEN1042 administration
• Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration.
• History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
• Toxicities from previous anti-cancer therapies that have not resolved