Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT07156227
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase I Trial of ATR Inhibitor Camonsertib Combined With Stereotactic Body Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety, side effects, and best dose of camonsertib in combination with stereotactic body radiation therapy in controlling disease in patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that cannot be removed by surgery (unresectable). Camonsertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving camonsertib in combination with stereotactic body radiation therapy may help control disease in patients with recurrent or unresectable head and neck squamous cell cancers.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of camonsertib with concurrent head and neck stereotactic body radiotherapy (SBRT) reirradiation for patients with recurrent head and neck squamous cell carcinoma (HNSCC).
II. To determine the recommended phase 2 dose (RP2D) of camonsertib in combination with concurrent SBRT in these patients.
SECONDARY OBJECTIVES:
I. To assess overall response rate within the radiation therapy field for patients treated with camonsertib and SBRT.
II. To assess progression-free survival (PFS) with camonsertib and SBRT in patients with recurrent or new primary HNSCC within a previously irradiated field.
EXPLORATORY OBJECTIVES:
I. To identify predictive biomarkers of response to camonsertib and SBRT, including, but not limited to genetic alterations of ATM and TP53, human papillomavirus (HPV) status, tumor mutational load, and circulating tumor deoxyribonucleic acid (DNA).
II. To characterize the pharmacokinetics (PK) of camonsertib.
OUTLINE: This is a dose-escalation study of camonsertib in combination with SBRT followed by a dose-expansion study.
Patients undergo SBRT twice weekly, 2-3 days apart, for 4 or 5 fractions over 3 weeks. Patients receive camonsertib orally (PO) once daily (QD) on the day of and the day after each radiation therapy treatment. Patients also undergo positron emission tomography (PET)/computed tomography (CT) or CT and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at weeks 4, 5, 6, 7, 16, 29, 42, and 55.
I. To evaluate the safety and tolerability of camonsertib with concurrent head and neck stereotactic body radiotherapy (SBRT) reirradiation for patients with recurrent head and neck squamous cell carcinoma (HNSCC).
II. To determine the recommended phase 2 dose (RP2D) of camonsertib in combination with concurrent SBRT in these patients.
SECONDARY OBJECTIVES:
I. To assess overall response rate within the radiation therapy field for patients treated with camonsertib and SBRT.
II. To assess progression-free survival (PFS) with camonsertib and SBRT in patients with recurrent or new primary HNSCC within a previously irradiated field.
EXPLORATORY OBJECTIVES:
I. To identify predictive biomarkers of response to camonsertib and SBRT, including, but not limited to genetic alterations of ATM and TP53, human papillomavirus (HPV) status, tumor mutational load, and circulating tumor deoxyribonucleic acid (DNA).
II. To characterize the pharmacokinetics (PK) of camonsertib.
OUTLINE: This is a dose-escalation study of camonsertib in combination with SBRT followed by a dose-expansion study.
Patients undergo SBRT twice weekly, 2-3 days apart, for 4 or 5 fractions over 3 weeks. Patients receive camonsertib orally (PO) once daily (QD) on the day of and the day after each radiation therapy treatment. Patients also undergo positron emission tomography (PET)/computed tomography (CT) or CT and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at weeks 4, 5, 6, 7, 16, 29, 42, and 55.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-06201 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 10732 | OTHER | UPMC Hillman Cancer Center LAO | View | |
| 10732 | OTHER | CTEP | View | |
| UM1CA186690 | NIH | None | https://reporter.nih.gov/quic… | View |