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.
Locations
36France
Centre Leon Berard69008, Lyon France
Gustave Roussy94805, Villejuif France
Italy
La Fondazione e l'Istituto di Candiolo10060, Candiolo Italy
Fondazione IRCCS Istituto Nazionale dei Tumori20123, Milan Italy
Sponsors and collaborators
Inhibrx Biosciences, Inc
Lead sponsor
Source ClinicalTrials.gov