NCT03715933 Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
| NCT ID | NCT03715933 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Inhibrx Biosciences, Inc |
| Condition | Ewing Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 411 participants |
| Start Date | 2018-10-08 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 411 participants in total. It began in 2018-10-08 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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/exclusion criteria is confirmed. 10. Acute viral or toxic liver disease within 12 months prior to the first dose of study drug. 11. Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. 12. Known sensitivity or contraindications to the following drugs: * Ewing sarcoma: irinotecan or TMZ * colorectal adenocarcinoma: FU, leucovorin, irinotecan, bevacizumab or FTP/TPI 13. Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment. 14. Acute, hemodynamically significant deep vein thrombosis or clinically significant pulmonary embolism not resolved or stable for at least 3 months prior to the start of study treatment. 15. Major surgery within 4 weeks prior to enrollment on this trial. 16. Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug. 17. Other exclusion criteria per protocol.
Contact & Investigator
Clinical Lead
STUDY DIRECTOR
Inhibrx Biosciences, Inc
Frequently Asked Questions
Who can join the NCT03715933 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 85 Years, studying Ewing Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03715933 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03715933 currently recruiting?
Yes, NCT03715933 is actively recruiting participants. Contact the research team at clinicaltrials@inhibrx.com for enrollment information.
Where is the NCT03715933 trial being conducted?
This trial is being conducted at Scottsdale, United States, Beverly Hills, United States, Duarte, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT03715933 clinical trial?
NCT03715933 is sponsored by Inhibrx Biosciences, Inc. The principal investigator is Clinical Lead at Inhibrx Biosciences, Inc. The trial plans to enroll 411 participants.