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

Status
Active
Cancer Type
Colon/Rectal Cancer
Sarcoma
Solid Tumor
Trial Phase
Phase I
Eligibility
12 - 85 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03715933
Protocol IDs
Ph1 INBRX-109 (primary)
NCI-2018-03556
Study Sponsor
Inhibrx, Inc.

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

  1. Males or females aged =12 to <85 years for Ewing sarcoma and 18 to <85 years of age for GIST.
  2. 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.
  3. 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.
  4. Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
  5. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  6. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.