Dear NRG Oncology colleagues,

 

I wanted to reach out and enthusiastically endorse the re-opening of NRG-DT001. This is a Phase Ib Trial of Neoadjuvant AMG-232 Concurrent with Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS).

 

To refresh everyone, the primary objective of the trial is to evaluate the safety and tolerability of AMG 232 in combination with standard-dose radiotherapy in STS in two separate patient cohorts (A, extremity or body wall; B, abdomen/pelvis/retroperitoneum) and determine the maximum tolerated dose/recommended phase II dose (MTD/RP2D) of AMG 232 in combination with radiotherapy 

 

Patient Population:

Patients with pathologically proven diagnosis of grade 2-3 (intermediate or high grade) soft tissue sarcoma with size ≥5 cm with the intention to treat curatively. Patients must have sufficient tissue to submit to central laboratory for review as well as for NGS sequencing.

 

The protocol was recently amended to reflect new biomarker information for TP53-wild type tumor status and is NOW open for accrual with a target goal of 46 patients. This the first Phase 1 trial emanating from the RT-DT committee and your support as we develop additional radiation-drug development pathways is crucial.

 

Sites with documentation of IRB approval of amendment 4 (submitted to the CTSU Regulatory Office prior to enrolling participants) may enroll. Expedited review is allowed at the discretion of the IRB Chair.

 

Warmest regards as we head into the holiday season – lets work to support these novel trials.

 

David Raben, M.D. (Co-Chair, Developmental Therapeutics, Radiation Therapy sub-committee)

Steven Lin, MD, PhD (Co-Chair, Developmental Therapeutics, Radiation Therapy sub-committee)

Meng Welliver, MD, Ph.D (Study PI)

Dian Wang, MD., Ph.D (Study Co-PI and Mentor)

 

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