GEN1042 Safety Trial in Subjects With Malignant Solid Tumors

Inclusion Criteria: Dose Escalation:

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

• Histologically or cytologically confirmed diagnosis of relapsed or refractory, advancedand/or metastatic melanoma, NSCLC, or CRC who are not anymore candidates for standardtherapy 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 adverseevents (irAEs).

• History of irAEs that led to treatment discontinuation of prior ICP inhibitor

• History of myositis, Guillain-Barré syndrome, or myasthenia gravis (any grade)

• History of chronic liver disease or evidence of hepatic cirrhosis.

• History of non-infectious pneumonitis that required steroids or currently haspneumonitis.

• History of organ allograft (except for corneal transplant) or autologous or allogeneicbone marrow transplant, or stem cell rescue within 3 months prior to the first dose ofGEN1042.

• Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.

• Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (< 6months) or progressive brain metastases or stroke. Prior therapy:

• Radiotherapy within 14 days prior to first GEN1042 administration

• Treatment with an anti-cancer agent (within 28 days or after at least 4 half-lives ofthe 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