Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Gastrointestinal Stromal Tumor

Recruiting

1

Start Date 10/10/2018

Age of Trial (yrs) 5.5

Gleevec-resistant

SDH-directed

Damage DNA and activate cell death receptor

Specifically GIST plus other cancers

Ph1 INBRX-109

Inhibrx, Inc.

Miranda Fox, Trial Manager 858-500-7833 clinicaltrials@inhibrx.com Kevin Bayer, Clinical Director clinicaltrials@inhibrx.com

Oral Intravenous

Partial Criteria 10/8/2022. Check NCT listing for full criteria.

Inclusion Criteria:

Escalation: Histologically or cytologically-confirmed advanced/metastatic or non-resectable solid tumors, including sarcoma, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
Expansion Cohorts: Malignant pleural mesothelioma, gastric adenocarcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma and certain sarcoma subtypes (e.g., chondrosarcoma, Ewing sarcoma), GIST, and SDH-def solid tumors with locally advanced or metastatic, non-resectable disease, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
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) of 0 or 1 for Part 1 and ECOG PS of 0, 1 or 2 for Parts 2 and 3.

Exclusion Criteria:

Prior treatment with or exposure to DR5 agonists.