Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-85
SponsorInhibrx Biosciences, Inc
About this trial
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
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- INBRX-109
- Irinotecan
- Temozolomide
- carboplatin
- pemetrexed
- Leucovorin
- Fluorouracil
- Bevacizumab
- Trifluridine + Tipiracil
Treatment groups
411 Participants
are divided into 14 treatment groups14
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov