NCT03284385

Testing AZD1775 in Advanced Solid Tumors That Have a Mutation Called SETD2

A Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor Malignancies

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well adavosertib works in treating patients with SETD2-deficient solid tumors that have spread to other places in the body (advanced/metastatic). Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria of adavosertib (AZD1775) in advanced solid tumor malignancies other than clear cell renal cell carcinoma with evidence of pathogenic loss of SETD2 using next-generation sequencing panel. II. To determine the objective response rate by RECIST 1.1 criteria of AZD1775 in clear cell renal cell carcinoma with evidence of loss of SETD2 using next-generation sequencing panel. SECONDARY OBJECTIVES: I. To determine the clinical benefit rate and duration of response of AZD1775 in SETD2-deficient tumors other than clear cell renal cell carcinoma. II. To determine the clinical benefit rate and duration of response of AZD1775 in SETD2-deficient clear cell renal cell carcinoma subgroup. III. To characterize the safety profile of AZD1775. IV. To determine whether H3K36me3 expression by immunohistochemical assay is associated with clinical outcomes. OUTLINE: Patients receive adavosertib orally (PO) once daily (QD) on days 1-5 and 8-12. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Clear Cell Renal Cell Carcinoma
• Locally Advanced Clear Cell Renal Cell Carcinoma
• Locally Advanced Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm
• Metastatic Renal Cell Carcinoma
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Adavosertib	Given PO

Timeline

• Start date: 2019-01-29
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2017-09-15
• Last updated: 2025-10-27

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study