Colorectal Adenocarcinoma, Ewing Sarcoma
Conditions
Keywords
Phase 1, Phase 1 Clinical Trial, Solid Tumors, Sarcoma, DR5, Ewing Sarcoma, CRC, colorectal adenocarcinoma
Brief summary
This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
Interventions
DRUGINBRX-109
Tetravalent DR5 Agonist Antibody
DRUGIrinotecan
Chemotherapy
DRUGTemozolomide
Chemotherapy
DRUGcarboplatin
chemotherapy
DRUGpemetrexed
chemotherapy
DRUGLeucovorin
chemotherapy
DRUGFluorouracil
chemotherapy
DRUGBevacizumab
targeted therapy
chemotherapy
Sponsors
Inhibrx Biosciences, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors. 2. Part 3 combination therapy expansion tumor types: * Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens. * Colorectal adenocarcinoma: Patients who have failed 1 (one) prior line of systemic therapy that did not include irinotecan. * Colorectal adenocarcinoma: Patients who have failed 2 but no more than 3 prior lines of systemic therapy and are FTD/TPI-naïve. 3. Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria. 4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, or Karnofsky Performance Status score of ≥60, or Lansky Play-Performance Scale for Children score ≥60 (for patients less than 16 years). 6. Estimated life expectancy of at least 12 weeks. 7. Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion criteria
1. Prior treatment with or exposure to DR5 agonists. 2. Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol. 3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies. 4. Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug. 5. Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol. 6. Prior or concurrent malignancies. Exceptions per protocol. 7. Hematologic malignancies. 8. Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol. Patients with any evidence or history of multiple sclerosis (MS) or other demyelinating disorders are excluded. 9. Chronic liver diseases including fatty liver. Exception: Patients \< 45 years old with fatty liver disease may be accepted as long as adequate hepatic function as defined in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of adverse events of INBRX-109 | Up to 8 years | Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. |
| Evaluating Tumor Response for colorectal cancers and Ewing sarcoma | Up to 8 years | Evaluating how the tumor responds to treatment by measuring the number of patients with colorectal cancer and Ewing sarcoma that experience tumor shrinkage and for how long. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median progression-free survival for colorectal adenocarcinoma and Ewing sarcoma. | Up to 8 years | Progression-free survival is defined as the time from start of study treatment until documented disease progression or death. |
| Immunogenicity of INBRX-109 | Up to 8 years | Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined. |
| Characterize the pharmacokinetics of INBRX-109 as a single agent, and of INBRX-109 in combination with distinct chemotherapies. | Up to 8 years | A measurement which indicates how the body processes INBRX-109 and how long it stays in the system. |
Countries
France, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
CONTACTStudy Director, -Inhibrx
STUDY_DIRECTORClinical Lead
Inhibrx Biosciences, Inc
Outcome results
None listed