NRG-DT001

A Phase Ib Trial of Neoadjuvant AMG 232 (KRT-232) Concurrent with Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS)

Principal Investigator

Meng Xu Welliver

Status

Disease Site

Other [DT] Sarcoma

Phase

I

Developmental Therapeutics

Yes

Primary Objective

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)

To 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.

 

 

 

Target Accrual

46