Description:
This is an open-label, single-country, multicenter, phase 1 dose escalation trial to assess the safety and pharmacokinetics (PK) of GEN1046.
This is an open-label, single-country, multicenter, phase 1 dose escalation trial to assess the safety and pharmacokinetics (PK) of GEN1046.
Recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
GEN1046 | GEN1046 (DuoBody®-PD-L1x4-1BB) | Single arm |
The purpose of the trial is to evaluate the safety and pharmacokinetics of GEN1046 in
Japanese subjects with malignant solid tumors.
Name | Type | Description | Interventions |
---|---|---|---|
Single arm | Experimental | GEN1046 open label, single arm trial where GEN1046 will be administered |
|
Key Inclusion Criteria: - Asian race and Japanese ethnicity - Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy - 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 - 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 GEN1046 - 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 first GEN1046 administration. 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 GEN1046 administration. Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid, etc.) and denosumab - Toxicities from previous anti-cancer therapies that have not adequately resolved
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Dose limiting toxicity (DLT) |
Time Frame: | DLTs are assessed during the first cycle (21 days) in each cohort |
Safety Issue: | |
Description: | The occurrence of any toxicities as outlined in the protocol will be considered |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Genmab |
August 13, 2021