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