CLINICAL TRIALS PROFILE FOR AZD1390

Clinical Trials for AZD1390

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03215381 ↗	AZD1390 Administration of a Microdose [11C]AZD1390 to Healthy Volunteers	Completed	Karolinska Institutet, Quintiles IMS	Phase 1	This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390 in healthy volunteer males.
NCT03215381 ↗	AZD1390 Administration of a Microdose [11C]AZD1390 to Healthy Volunteers	Completed	AstraZeneca	Phase 1	This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390 in healthy volunteer males.
NCT03423628 ↗	A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer	Recruiting	AstraZeneca	Phase 1	This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy
NCT04550104 ↗	A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC	Recruiting	Beatson West of Scotland Cancer Centre	Phase 1	CONCORDE is a multi-institution, multi-arm, Phase IB study that will determine the recommended phase II dose (RP2D) and safety profiles of different DNA damage repair inhibitors (DDRis) when given in an open label fashion in combination with fixed dose curative intent radiotherapy (RT) in patients with stage IIB/IIIA/IIIB NSCLC. The RP2D will be evaluated by incorporating the number of observed dose limiting toxicities (DLTs) into a time to event continuous reassessment method (TiTE- CRM) model within each of the experimental arms. TiTE-CRM is used here to take into account longer-term toxicities up to 13.5 months post start of radiotherapy and use these to inform dose escalation decision making.
NCT04550104 ↗	A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC	Recruiting	Newcastle University	Phase 1	CONCORDE is a multi-institution, multi-arm, Phase IB study that will determine the recommended phase II dose (RP2D) and safety profiles of different DNA damage repair inhibitors (DDRis) when given in an open label fashion in combination with fixed dose curative intent radiotherapy (RT) in patients with stage IIB/IIIA/IIIB NSCLC. The RP2D will be evaluated by incorporating the number of observed dose limiting toxicities (DLTs) into a time to event continuous reassessment method (TiTE- CRM) model within each of the experimental arms. TiTE-CRM is used here to take into account longer-term toxicities up to 13.5 months post start of radiotherapy and use these to inform dose escalation decision making.

Clinical Trial Conditions for AZD1390

Condition Name

Condition Name for
Intervention	Trials
Solid Tumor, Adult	1
Healthy Volunteer Male Subjects	1
Leptomeningeal Disease (LMD)	1
Metastatic Cancer	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Neoplasms	2
Glioblastoma	2
Carcinoma, Non-Small-Cell Lung	1
Brain Neoplasms	1

Clinical Trial Locations for AZD1390

Trials by Country

Trials by Country for
Location	Trials
United States	7
United Kingdom	2
Sweden	1

Trials by US State

Trials by US State for
Location	Trials
New York	2
Washington	1
Arizona	1
Virginia	1
Pennsylvania	1

Clinical Trial Progress for AZD1390

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 1	4
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Not yet recruiting	2
Recruiting	2
Completed	1

Clinical Trial Sponsors for AZD1390

Sponsor Name

Sponsor Name for
Sponsor	Trials
AstraZeneca	4
University College London Hospitals	1
University of Glasgow	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Other	16
Industry	4