GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Prior treatment

• Have uncontrolled intercurrent illness, including but not limited to: • Ongoing or active infection requiring intravenous treatment with antiinfective therapy, or any ongoing systemic inflammatory condition requiring further diagnostic work-up or management during screening. • Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia • Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic 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 any grade • History of chronic liver disease or evidence of hepatic cirrhosis • History of non-infectious pneumonitis that has 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 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 5 half-lives of the drug, whichever is shorter), prior to acasunlimab administration. 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.

• 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