Camonsertib + Radiation Therapy for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for individuals with recurrent or hard-to-treat head and neck cancer. The researchers aim to determine if camonsertib, a potential new drug, combined with a precise form of radiation therapy, can safely and effectively control cancer growth. The trial targets patients whose cancer has returned after prior treatment or cannot be surgically removed. Those with head and neck cancer that cannot be surgically removed and have already undergone radiation therapy might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you must stop taking your current medications, but you cannot use strong CYP3A4/5 inhibitors and inducers, or strong P-gp and BCRP inhibitors while participating. It's important to discuss your current medications with the trial team to ensure there are no interactions.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that camonsertib, when used alone, was safe in earlier studies. In one study involving 120 patients with various advanced cancers, camonsertib was administered alone and was generally well-tolerated. Patients experienced some side effects, but these were manageable. Another study tested camonsertib with a low dose of gemcitabine (a chemotherapy drug) and found this combination to be safe as well.
Currently, researchers are testing camonsertib with a precise form of radiation treatment called stereotactic body radiation therapy for head and neck cancer. Although this specific combination remains in the early testing phase, earlier findings suggest it could be safe for patients. However, since this trial is in its first phase, the main focus is on determining the best dose and identifying any possible side effects.12345Why do researchers think this study treatment might be promising for head and neck cancer?
Researchers are excited about the combination of camonsertib and stereotactic body radiation therapy (SBRT) for head and neck cancer because it offers a unique approach to treatment. Unlike traditional treatments that may involve extensive surgery or long courses of radiation and chemotherapy, this combination targets cancer cells more precisely and may reduce treatment time. Camonsertib is an innovative oral drug that enhances the effects of radiation by interfering with cancer cell DNA repair processes, potentially increasing the effectiveness of SBRT. This approach could lead to more effective treatments with fewer side effects, offering new hope for patients with head and neck cancer.
What evidence suggests that camonsertib combined with stereotactic body radiation therapy might be an effective treatment for head and neck cancer?
Research has shown that camonsertib, when combined with radiation therapy, might help manage head and neck cancer. In this trial, participants will receive camonsertib alongside Stereotactic Body Radiation Therapy (SBRT). Early results suggest that camonsertib increases cancer cells' sensitivity to radiation, enhancing its effectiveness. In studies involving advanced solid tumors, camonsertib demonstrated potential in slowing tumor growth. This combined approach aims to target cancer cells more precisely while protecting healthy tissue. Initial clinical findings provide hope for improved outcomes in patients with recurring or difficult-to-remove head and neck cancers.12678
Who Is on the Research Team?
Yvonne M Mowery
Principal Investigator
UPMC Hillman Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults (18+) with head and neck squamous cell cancer that has come back or can't be removed by surgery, who had prior radiation at least 6 months ago. Participants need to have enough healthy blood cells, measurable disease on scans, and be well enough to do daily activities.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo 4 or 5 treatment fractions of SBRT twice weekly, 2-3 days apart between fractions, over 3 weeks. Patients receive camonsertib orally once daily on the day of and the day after each radiation therapy treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion with follow-up visits at weeks 4, 5, 6, 7, 16, 29, 42, and 55.
What Are the Treatments Tested in This Trial?
Interventions
- Camonsertib
- Stereotactic Body Radiation Therapy
Trial Overview
The study is testing the safety and best dose of a new drug called camonsertib when given together with precise radiation therapy (stereotactic body radiation) in people with recurrent or hard-to-remove head and neck cancers.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo 4 or 5 treatment fractions of SBRT twice weekly, 2-3 days apart between fractions, over 3 weeks. Patients receive camonsertib PO QD on the day of and the day after each radiation therapy treatment. Patients also undergo PET/CT or CT and collection of blood samples throughout the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
NCT07156227 | Testing the Addition of an Anti-Cancer ...
Giving camonsertib in combination with stereotactic body radiation therapy may help control disease in patients with recurrent or unresectable head and neck ...
Camonsertib in DNA damage response-deficient advanced ...
Here we report the results from module 1 of an ongoing phase 1 trial of the ATRi camonsertib (RP-3500) in 120 patients with advanced solid tumors.
Evidence-Based Treatment Options in Recurrent and/or ... - PMC
Finally, patient-reported outcomes from CheckMate 141 revealed stabilization or slight improvement in quality of life measures such as social functioning and ...
4.
ir.reparerx.com
ir.reparerx.com/news-releases/news-release-details/repare-therapeutics-announces-phase-1-data-highlightingRepare Therapeutics Announces Phase 1 Data ...
“This first-in-human study combining camonsertib, an ATR inhibitor, with palliative radiation provides early clinical data showing that the ...
ATR Inhibition as a Radiosensitization Strategy in Naturally ...
Preliminary data suggest that camonsertib enhances radiosensitivity in FOSCC, with promising in vitro and in vivo clinical findings. This clinical trial design ...
6.
ir.reparerx.com
ir.reparerx.com/news-releases/news-release-details/repare-therapeutics-provides-business-update-and-reports-first-0Repare Therapeutics Provides Business Update and ...
“The findings continue to demonstrate camonsertib's promising clinical benefit given as monotherapy in patients with solid tumors with multiple ...
Camonsertib, an ATRi, in Combination with Low-Dose ... - PMC
The work presented here details the safety, tolerability, and preliminary efficacy data of combined gemcitabine and the ataxia telangiectasia and Rad3-related ...
EX-99.1
Camonsertib monotherapy resulted in durable clinical benefit across tumor types and genomic alterations. Overall clinical benefit rate (CBR) for ...
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