A Phase 2 Study of GPNMB-Targeted Antibody-Drug Conjugate CDX-011 (Glembatumumab Vedotin CR011-vcMMAE; NSC# 763737) in Recurrent or Refractory Osteosarcoma

K
Kamnesh Pradhan, MD

Primary Investigator

Overview

This phase II trial studies how well glembatumumab vedotin works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory).

Description

The purpose of this study is to estimate whether CDX-011 (glembatumumab vedotin) therapy either increases the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to an historical Children's Oncology Group (COG) experience or produces an objective response rate in patients without previous eribulin (eribulin mesylate) treatment.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Osteosarcoma,Recurrent Osteosarcoma
  • Age: Between 12 Years - 49 Years
  • Gender: All

Inclusion Criteria
Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse
Patients must have measurable disease according to RECIST 1.1, and have relapsed or become refractory to conventional therapy
Patient must have archival tumor specimen available for submission
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients == 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment
Exclusion Criteria
Patients with > grade 2 neuropathy according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery
Patients who have previously received CDX-011 (CR011-vc monomethyl auristatin E [MMAE]; CDX-011) or other MMAE-containing agents
Patients who have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment
Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin; compounds of similar composition include auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent
Patients with known central nervous system metastasis are not eligible
Patients who have had major surgery within 2 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter, or limited tumor biopsy, are not considered major surgery
Female patients who are pregnant are ineligible
Lactating females are not eligible unless they have agreed not to breastfeed their infants
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 2 months after the end of study treatment


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022. Study ID: 1602897026 (AOST1521)

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