Overview
The trial is an open-label, multi-center safety trial of acasunlimab (GEN1046). The trial consists of two parts, a dose escalation part (phase 1, first-in-human \[FIH\] and an expansion part \[phase 2a\]). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.
Principal investigator
Eligibility criteria
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-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
* 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.
* 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-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
* 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 Referring Providers
Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.