This is a first-in-human, open-label, non-randomized, two-part phase 1 trial of INBRX-109, which is a recombinant humanized multivalent antibody targeting the human death receptor 5 (DR5).
|First Received Date||October 11, 2018|
|Last Changed Date||January 17, 2019|
|Start Date||October 5, 2018|
|Anticipated Primary Completion Date||May 2020|
|Primary Outcome Measures||
Frequency and severity of adverse events of INBRX-109 [Time Frame: Up to 2 years]
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-109 [Time Frame: Up to 2 years]
|Secondary Outcome Measures||
Area under the serum concentration time curve (AUC) of INBRX-109 [Time Frame: Up to 2 years]
Immunogenicity of INBRX-109 [Time Frame: Up to 2 years]
Maximum observed serum concentration (Cmax) of INBRX-109 [Time Frame: Up to 2 years]
Trough observed serum concentration (Ctrough) of INBRX-109 [Time Frame: Up to 2 years]
Time to Cmax (Tmax) of INBRX-109 [Time Frame: Up to 2 years]
|Study Arms / Comparison Groups||4 / 0|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
Kirsti Cook, DirClinOps
- Part 1 Escalation: Histologically or cytologically-confirmed advanced/metastatic or nonresectable solid tumors, including sarcoma, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
- Part 2 Expansion Cohorts: Malignant pleural mesothelioma, gastric adenocarcinoma and colorectal adenocarcinoma with locally advanced or metastatic, non-resectable disease, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
- Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
- Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 for Part 1 and ECOG PS of 0, 1 or 2 for Part 2.
- Prior treatment with or exposure to DR5 agonists.
- Receipt of investigational agents or devices, anticancer therapy and radiotherapy (with the exception of palliative localized radiation) within 4 weeks prior to the first dose of study drug, and liver-directed therapies (i.e., RFA, TACE/embolization, cryotherapy, SBRT) within 12 weeks prior to the first dose of study drug. Exceptions per protocol.
- Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exception: Participants who have had a stem cell or bone marrow transplant > 5 years ago are eligible for enrollment, as long as there are no symptoms of graft-versus-host disease (GVHD).
- Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-109.
- Hematologic malignancies.
- Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: Subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply.
- Subjects with chronic liver diseases including but not limited to cirrhosis, non-alcoholic fatty liver disease, alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatic or biliary autoimmune disorders (i.e., primary biliary cholangitis, autoimmune hepatitis).
- Acute viral or toxic liver disease within 4 weeks prior to the first dose of study drug.
- Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
- Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension. Active, hemodynamically significant pulmonary embolism within 3 months prior to enrollment on this trial.
- Major surgery within 4 weeks prior to enrollment on this trial.
- Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
|Verification Date||January 2019|