Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including… (NCT03715933) | Clinical Trial Compass
RecruitingPhase 1
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
United States321 participantsStarted 2018-10-08
Plain-language 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).
Who can participate
Age range12 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Part 3 combination therapy expansion tumor types:
✓. 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) 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).
✓. Estimated life expectancy of at least 12 weeks.
✓. Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion criteria
✕. Prior treatment with or exposure to DR5 agonists.
✕. 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.
✕. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
✕. 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.
✕
What they're measuring
1
Frequency and severity of adverse events of INBRX-109
Timeframe: Up to 8 years
2
Evaluating Tumor Response for colorectal cancers and Ewing sarcoma
. Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.
✕. Prior or concurrent malignancies. Exceptions per protocol.
✕. Hematologic malignancies.
✕. 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.