GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Key Inclusion Criteria:

For Dose Escalation:

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

For Expansion:

• Have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for standard therapy For separate expansion cohorts: metastatic NSCLC without prior systemic treatment regimens for metastatic disease.

For Both Dose Escalation and Expansion

• Have measurable disease according to RECIST 1.1

• Have Eastern Cooperative Oncology Group (ECOG) 0-1

• Have an acceptable hematological status

• Have acceptable liver function

• Have an acceptable coagulation status

• Have acceptable renal function

Key Exclusion Criteria:

• Have uncontrolled intercurrent illness, including but not limited to:

• Ongoing or active infection requiring intravenous treatment with anti-infectivetherapy, or any ongoing systemic inflammatory condition requiring furtherdiagnostic work-up or management during screening.

• Symptomatic congestive heart failure (Grade III or IV as classified by the NewYork Heart Association), unstable angina pectoris or cardiac arrhythmia

• Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/ordiastolic blood pressure ≥ 100 mmHg, despite optimal medical management

• Ongoing or recent evidence of autoimmune disease

• History of irAEs that led to prior checkpoint treatment discontinuation

• Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of anygrade

• History of chronic liver disease or evidence of hepatic cirrhosis

• History of non-infectious pneumonitis that has required steroids or currentlyhas pneumonitis

• History of organ allograft (except for corneal transplant) or autologous orallogeneic bone marrow transplant, or stem cell rescue within 3 months prior tothe first dose of acasunlimab

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

• Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke

• Prior therapy:

• Radiotherapy within 14 days prior to first dose of acasunlimab. Note:palliative radiotherapy will be allowed.

• Treatment with an anti-cancer agent (within 28 days or after at least 5half-lives of the drug, whichever is shorter), prior to acasunlimabadministration. Accepted exceptions are bisphosphonates (e.g., pamidronate,zoledronic acid, etc.) and denosumab

• Toxicities from previous anti-cancer therapies that have not adequately resolved

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.