NCT05678010

A Study of AZD1390 and Stereotactic Body Radiotherapy (SBRT) for People With Metastatic Solid Tumor Cancer

A Phase I Study Assessing the Safety and Tolerability of Ascending Doses of AZD1390 in Combination With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Solid Tumor Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether AZD1390 combined with stereotactic body radiation therapy/SBRT is a safe treatment for people with metastatic solid tumor cancer

Conditions

• Solid Tumor
• Metastatic Solid Tumor
• Solid Carcinoma
• Solid Tumor, Adult
• Metastatic Tumor
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	AZD1390	Dose level 1: 20 Dose level 2: 40 Dose level 3: 60 Dose level 4: 80
RADIATION	Stereotactic Body Radiotherapy	Participants will receive Stereotactic Body Radiotherapy/SBRT to 2 sites of metastatic tumors consecutively. The two treatment sites will be randomized to SBRT to one site and SBRT + AZD1390 to the other site. Both sites will receive 30Gy in 5 fractions.

Timeline

• Start date: 2023-05-17
• Primary completion: 2028-05-17
• Completion: 2028-05-17
• First posted: 2023-01-10
• Last updated: 2025-05-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study