Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04937153
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : August 13, 2021
Sponsor:
Collaborator:
BioNTech SE
Information provided by (Responsible Party):
Genmab

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
Solid Tumor Biological: GEN1046 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: The starting dose is 15 mg administered as a flat dose. Dose escalation steps are based on safety data.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Dose-escalation Trial to Evaluate the Safety and Pharmacokinetics of GEN1046 in Japanese Subjects With Advanced Solid Malignancies
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : November 13, 2022
Estimated Study Completion Date : November 13, 2022

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 Name: GEN1046 (DuoBody®-PD-L1x4-1BB)




Primary Outcome Measures :
  1. Dose limiting toxicity (DLT) [ Time Frame: 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

  2. Adverse events [ Time Frame: AEs are collected up to 2 months after last subject last treatment ]
    Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0

  3. Safety laboratory parameters (hematology) [ Time Frame: Safety laboratory data are collected up to 2 months after last subject last treatment ]
    Laboratory parameters graded by CTCAE v5.0

  4. Safety laboratory parameters (biochemistry) [ Time Frame: Safety laboratory data are collected up to 2 months after last subject last treatment ]
    Laboratory parameters graded by CTCAE v5.0

  5. Safety laboratory parameters (coagulation) [ Time Frame: Safety laboratory data are collected up to 2 months after last subject last treatment ]
    Laboratory parameters graded by CTCAE v5.0

  6. Safety laboratory parameters (endocrines) [ Time Frame: Safety laboratory data are collected up to 2 months after last subject last treatment ]
    Laboratory parameters graded by CTCAE v5.0

  7. PK parameters [ Time Frame: PK data are collected until treatment discontinuation of the last subject ]
    Predose trough concentrations (Ctrough)

  8. PK parameters [ Time Frame: PK data are collected until treatment discontinuation of the last subject ]
    Half-life (T1/2)

  9. PK parameters [ Time Frame: PK data are collected until treatment discontinuation of the last subject ]
    Time of Cmax (Tmax)

  10. PK parameters [ Time Frame: PK data are collected until treatment discontinuation of the last subject ]
    Area-under-the-concentration-time curve (AUC)

  11. PK parameters [ Time Frame: PK data are collected until treatment discontinuation of the last subject ]
    Maximum concentration (Cmax)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04937153


Contacts
Layout table for location contacts
Contact: Genmab Trial Information +4570202728 clinicaltrials@genmab.com

Locations
Layout table for location information
Japan
National Cancer Center East Recruiting
Tokyo, Japan
National Cancer Center Hospital Recruiting
Tokyo, Japan
Sponsors and Collaborators
Genmab
BioNTech SE
Investigators
Layout table for investigator information
Study Director: Edward Ramirez Ganoza, MD Genmab
Layout table for additonal information
Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT04937153    
Other Study ID Numbers: GCT1046-02
First Posted: June 23, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms