Malignant Solid Tumors - Non Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DuoBody-PD-L1x4-1BB
Product Code: GEN1046
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not issued
CAS Number: 2253937-12-9
Current Sponsor code: GEN104
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must sign an informed consent form (ICF). 2. Subject must be at least 18 years of age. 3. Subject has histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 mAb for metastatic disease. 4. Subject must have PD-L1 tumor expression score of TPS =1%assessed by a central laboratory during screening. 5. Subject must have measurable disease per RECIST v1.1. 6. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) =1. 7. Subject must have life expectancy of at least 3 months. 8. Subject must have adequate organ and bone marrow function as defined in protocol. For further information, please refer to Clinical Trial Protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 63
Exclusion criteria
Exclusion criteria: 1. Documentation of known EGFR, ROS1, or ALK mutations or gene rearrangements. Additionally, the statues of BRAF, METex 14 skipping, KRAS mutations, RET rearrangement, high-level MET amplification, or NTRK gene infusions will be required. 2. Subject has been exposed to any of the following therapies: - Treatment with an anti-cancer agent within 28 days prior to GEN1046 administration. - Any investigational agent for the treatment of stage 4 NSCLC. - Radiotherapy within 14 days prior to first GEN1046 administration. If a subject received radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention. - Chronic systemic immunosuppressive corticosteroid doses, ie, prednisone >10 mg daily or a cumulative dose >150 mg prednisone within 14 days before the first GEN1046 administration. 3. Subject has contraindications to the use of pembrolizumab per local prescribing information. 4. Subject has any of the following: - Ongoing or active infection requiring intravenous treatment with anti-infective therapy that has been administered <2 weeks prior to first dose. - 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 (within 6 months) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs. 5. Subject has a known history of any of the following: - Grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment. - Myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade. - Liver disease (eg, alcoholic hepatitis or non-alcoholic steatohepatitis, drug-related or autoimmune hepatitis, or evidence of hepatic cirrhosis). - 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. - Grade 3 or higher allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial. For further information, please refer to Clinical Trial Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the anti-tumor activity of GEN1046 as monotherapy and in combination with anti-cancer therapy in subjects with relapsed/refractory metastatic NSCLC;Secondary Objective: • Evaluate time to onset and durability of the anti-tumor response of GEN1046 as monotherapy and in combination with anti-cancer therapy in subjects with relapsed/refractory metastatic NSCLC • Evaluate the clinical benefit of GEN1046 as monotherapy and in combination with anti-cancer therapy • Assess safety and tolerability of GEN1046 as monotherapy and in combination with anti-cancer therapy;Primary end point(s): • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator;Timepoint(s) of evaluation of this end point: ORR is defined as the proportion of subjects with a confirmed response of partial response (PR) or complete response (CR) according to RECIST v1.1 criteria. The minimum time from first infusion of trial drug required to qualify for an assessment of stable disease (SD) is 5 weeks, corresponding to the minimum planned time of the first imaging assessment. Disease will be evaluated per RECIST v1.1. CT with contrast (preferred) or MRI will be obtained at baseline before the first dose and 6, 12, 18, and 24 weeks (±7 days) after the first dose of trial medication, and thereafter, every 9 weeks (±7 days). CT or MRI will continue to be obtained until disease progression, start of subsequent anti-cancer therapy, withdrawal of consent, or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - DOR: DOR is defined for responders as the time from initial onset of response to first progression event, defined as radiographic progression or death. - TTR: Time to response (TTR) is defined as the time from first infusion of trial drug to onset of response. - PFS: PFS is defined as the time from first infusion of trial drug to first progression event, defined as radiographic progression or death. - OS: OS is defined as time from first infusion of trial drug to death due to any cause. - Safety, including AEs, physical examinations, Eastern Cooperative Oncology Group (ECOG)performance status (PS), vital signs, electrocardiograms, and laboratory values, will be monitored throughout the trial.;Secondary end point(s): • Duration of response (DOR) per RECIST v1.1 • Time to response (TTR) per RECIST v1.1 • Progression-free survival (PFS) per RECIST v1.1 • Overall survival (OS) • Incidence and severity of AEs • Incidence and severity of laboratory abnormalities | — |
Countries
Czechia, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Genmab A/S
Outcome results
None listed