Current Research Studies

PEPN2121 A Phase 1/2 Study of Tiragolumab (NSC# 827799, IND# 161266) and Atezolizumab (NSC# 783608, IND# 161266) in Patients with Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors


What is the goal of the study?

This is a phase 1/2 trial of tiragolumab as a monotherapy and in combination with atezolizumab in SMARCB1 and SMARCA4 deficient tumors in ages > 12 months. Part A will evaluate the safety of tiragolumab as a monotherapy in patients <18 years of age. patients enrolled on part a may receive tirogolomab in combination with atezolizumab in second and subsequent cycles. part b will estimate the antitumor activity of tiragolumab in combination with atezolizumab in six different disease cohorts including renal medullary carcinoma, malignant rhabdoid tumor, atypical teratoid rhabdoid tumor, poorly differentiated carcinoma, epithelioid sarcoma, and others. parts a and b will simultaneously open for enrollment. up to 6 evaluable patients><18 years old will be enrolled on part a to assess safety of tiragolumab monotherapy based on cycle 1 dlts. if the pediatric dose of tiragolumab is assessed to be safe, patients><18 years old may be enrolled on the part b portion of the study. eligible adult patients (≥18 years) may enroll on the part b portion of the trial while the part a component of the study is being conducted in patients younger than 18 years old. part b will monitor cycle 1 toxicities of the combination therapy using a bayesian optimal interval (boin) design in the pediatric population>< 12 years of age receiving the combination of tiragolumab and atezolizumab. In addition, all Part B patients will be monitored for treatment-related death or specific Grade 4 toxicities across all cycles of therapy. The secondary objectives will be to describe adverse events, pharmacokinetics (PK), and anti-drug antibody (ADA) in all patients and estimating progression free survival (PFS), overall survival (OS), and duration of response in all patients with SMARCB1/SMARCA4 deficient tumors. Keywords: SMARC, SMARCB1, SMARCA4, PEPN2121, PEPN 2121, Phase 1, Phase 2, Phase 1/2, Tiragolumab, Atezolizumab, Solid Tumor, Relapsed, Refractory

Who can participate in the study?

Please contact the study team listed below to learn more.

Study Team: