Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/27/2019 |
Start Date: | October 5, 2018 |
End Date: | July 2020 |
Contact: | Kirsti Cook, DirClinOps |
Email: | clinicaltrials@inhibrx.com |
Phone: | 949-264-3862 |
An Open-Label, Multicenter, First-in-Human, Dose-Escalation Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
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).
which is a recombinant humanized multivalent antibody targeting the human death receptor 5
(DR5).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
5
sites
12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Christopher Lieu, MD
Phone: 720-848-4394
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Principal Investigator: Hedy Kindler, MD
Phone: 773-834-1472
University of Chicago One of the world's premier academic and research institutions, the University of...
Click here to add this to my saved trials
Grand Rapids, Michigan 49546
Principal Investigator: Nehal Lakhani, MD
Phone: 616-389-1739
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Vivek Subbiah, MD
Phone: 713-792-2913
Click here to add this to my saved trials
5206 Research Drive
San Antonio, Texas 78240
San Antonio, Texas 78240
Principal Investigator: Anthony Tolcher, MD
Phone: 210-595-5670
Click here to add this to my saved trials