GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies
Study Details
Study Description
Brief Summary
This is an open-label, single-country, multicenter, phase 1 dose escalation trial to assess the safety and pharmacokinetics (PK) of GEN1046.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The purpose of the trial is to evaluate the safety and pharmacokinetics of GEN1046 in Japanese subjects with malignant solid tumors.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single arm GEN1046 open label, single arm trial where GEN1046 will be administered |
Biological: GEN1046
GEN1046 will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Dose limiting toxicity (DLT) [DLTs are assessed during the first cycle (21 days) in each cohort]
The occurrence of any toxicities as outlined in the protocol will be considered
- Adverse events [AEs are collected up to 2 months after last subject last treatment]
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
- Safety laboratory parameters (hematology) [Safety laboratory data are collected up to 2 months after last subject last treatment]
Laboratory parameters graded by CTCAE v5.0
- Safety laboratory parameters (biochemistry) [Safety laboratory data are collected up to 2 months after last subject last treatment]
Laboratory parameters graded by CTCAE v5.0
- Safety laboratory parameters (coagulation) [Safety laboratory data are collected up to 2 months after last subject last treatment]
Laboratory parameters graded by CTCAE v5.0
- Safety laboratory parameters (endocrines) [Safety laboratory data are collected up to 2 months after last subject last treatment]
Laboratory parameters graded by CTCAE v5.0
- PK parameters [PK data are collected until treatment discontinuation of the last subject]
Predose trough concentrations (Ctrough)
- PK parameters [PK data are collected until treatment discontinuation of the last subject]
Half-life (T1/2)
- PK parameters [PK data are collected until treatment discontinuation of the last subject]
Time of Cmax (Tmax)
- PK parameters [PK data are collected until treatment discontinuation of the last subject]
Area-under-the-concentration-time curve (AUC)
- PK parameters [PK data are collected until treatment discontinuation of the last subject]
Maximum concentration (Cmax)
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Asian race and Japanese ethnicity
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Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy
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Have measurable disease according to RECIST 1.1
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Have Eastern Cooperative Oncology Group (ECOG) 0-1
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Have an acceptable hematological status
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Have acceptable liver function
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Have an acceptable coagulation status
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Have acceptable renal function
Key Exclusion Criteria:
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Have uncontrolled intercurrent illness, including but not limited to:
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Ongoing or active infection requiring intravenous treatment with anti-infective therapy
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Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia
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Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management
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Ongoing or recent evidence of autoimmune disease
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History of irAEs that led to prior checkpoint treatment discontinuation
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Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade
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History of chronic liver disease or evidence of hepatic cirrhosis
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History of non-infectious pneumonitis that has required steroids or currently has pneumonitis
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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
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Serious, non-healing wound, skin ulcer (of any grade), or bone fracture
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Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
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Prior therapy:
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Radiotherapy: Radiotherapy within 14 days prior to first GEN1046 administration. Palliative radiotherapy will be allowed.
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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
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Toxicities from previous anti-cancer therapies that have not adequately resolved
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cancer Center East | Tokyo | Japan | ||
| 2 | National Cancer Center Hospital | Tokyo | Japan |
Sponsors and Collaborators
- Genmab
- BioNTech SE
Investigators
- Study Director: Edward Ramirez Ganoza, MD, Genmab
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GCT1046-02