gen1046 safety and pk in subjects with advanced solid malignancies

Conditions: Solid Tumor

Summary: the primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (dlt) and pharmacokinetics (pk) of acasunlimab (also known as gen1046) administered as monotherapy or in combination with pembrolizumab in japanese study participants with malignant solid tumors.


Eligibility criteria:
key inclusion criteria: * participant must have a histologically-confirmed non-central nervous system (cns) solid tumor that is metastatic or unresectable and for whom there is no available standard therapy likely to confer clinical benefit; or a participant who is not a candidate for such available therapy and for whom, in the opinion of the investigator, experimental therapy with acasunlimab or acasunlimab in combination with pembrolizumab may be beneficial. * asian race and japanese ethnicity. * have measurable disease according to response evaluation criteria in solid tumors (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. * should provide a tumor tissue sample (formalin-fixed paraffin-embedded \[ffpe\] blocks/slides) from archival tissue or fresh biopsy collected before c1d1, preferably derived from advanced disease stage. key exclusion criteria: * have uncontrolled intercurrent illness, including but not limited to: * ongoing or active infection requiring intravenous treatment with anti-infective 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. * evidence of interstitial lung disease. * 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 trial treatment. * 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: radiotherapy within 14 days prior to the first dose of trial treatment. 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 trial treatment administration. * toxicities from previous anti-cancer therapies that have not adequately resolved. note: other protocol specified inclusion/exclusion criteria may apply.