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
Sponsor: National Cancer Institute (NCI)
This observational or N/A phase trial investigates Clear Cell Renal Cell Carcinoma and Locally Advanced Clear Cell Renal Cell Carcinoma and is currently ongoing. National Cancer Institute (NCI) leads this study, which shows 49 recorded versions since 2019 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
49 versions recorded-
Apr 28, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE2 → None
-
Nov 2025 — Apr 2026 [monthly]
Active Not Recruiting PHASE2
-
Oct 2025 — Nov 2025 [monthly]
Active Not Recruiting PHASE2
-
Sep 2025 — Oct 2025 [monthly]
Active Not Recruiting PHASE2
-
Mar 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE2
▶ Show 44 earlier versions
-
Sep 2024 — Mar 2025 [monthly]
Active Not Recruiting PHASE2
-
Aug 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
-
Jul 2024 — Aug 2024 [monthly]
Active Not Recruiting PHASE2
-
Apr 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
-
Dec 2023 — Apr 2024 [monthly]
Active Not Recruiting PHASE2
-
Oct 2023 — Dec 2023 [monthly]
Active Not Recruiting PHASE2
-
Apr 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE2
-
Sep 2022 — Apr 2023 [monthly]
Active Not Recruiting PHASE2
-
Jul 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE2
-
Apr 2022 — Jul 2022 [monthly]
Active Not Recruiting PHASE2
Status: Suspended → Active Not Recruiting
-
Jan 2022 — Apr 2022 [monthly]
Suspended PHASE2
Status: Recruiting → Suspended
-
Oct 2021 — Jan 2022 [monthly]
Recruiting PHASE2
-
Sep 2021 — Oct 2021 [monthly]
Recruiting PHASE2
-
May 2021 — Sep 2021 [monthly]
Recruiting PHASE2
-
Mar 2021 — May 2021 [monthly]
Recruiting PHASE2
-
Feb 2021 — Mar 2021 [monthly]
Recruiting PHASE2
-
Jan 2021 — Feb 2021 [monthly]
Recruiting PHASE2
-
Dec 2020 — Jan 2021 [monthly]
Recruiting PHASE2
-
Nov 2020 — Dec 2020 [monthly]
Recruiting PHASE2
-
Oct 2020 — Nov 2020 [monthly]
Recruiting PHASE2
-
Sep 2020 — Oct 2020 [monthly]
Recruiting PHASE2
-
Aug 2020 — Sep 2020 [monthly]
Recruiting PHASE2
-
Jul 2020 — Aug 2020 [monthly]
Recruiting PHASE2
-
May 2020 — Jul 2020 [monthly]
Recruiting PHASE2
-
Apr 2020 — May 2020 [monthly]
Recruiting PHASE2
-
Mar 2020 — Apr 2020 [monthly]
Recruiting PHASE2
-
Feb 2020 — Mar 2020 [monthly]
Recruiting PHASE2
-
Dec 2019 — Feb 2020 [monthly]
Recruiting PHASE2
-
Nov 2019 — Dec 2019 [monthly]
Recruiting PHASE2
-
Oct 2019 — Nov 2019 [monthly]
Recruiting PHASE2
-
Sep 2019 — Oct 2019 [monthly]
Recruiting PHASE2
-
Aug 2019 — Sep 2019 [monthly]
Recruiting PHASE2
-
Jul 2019 — Aug 2019 [monthly]
Recruiting PHASE2
-
Jun 2019 — Jul 2019 [monthly]
Recruiting PHASE2
-
Mar 2019 — Jun 2019 [monthly]
Recruiting PHASE2
-
Feb 2019 — Mar 2019 [monthly]
Recruiting PHASE2
-
Jan 2019 — Feb 2019 [monthly]
Recruiting PHASE2
-
Dec 2018 — Jan 2019 [monthly]
Recruiting PHASE2
-
Sep 2018 — Dec 2018 [monthly]
Recruiting PHASE2
-
Aug 2018 — Sep 2018 [monthly]
Recruiting PHASE2
-
Jul 2018 — Aug 2018 [monthly]
Recruiting PHASE2
-
Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
-
Mar 2018 — Jun 2018 [monthly]
Not Yet Recruiting PHASE2
-
Oct 2017 — Mar 2018 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility 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.
Contact Information
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .