Safety, Tolerability, PK, and Efficacy of CD-001 in Advanced Head & Neck Cancers (NCT07072325) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety, Tolerability, PK, and Efficacy of CD-001 in Advanced Head & Neck Cancers
9 participantsStarted 2025-08-10
Plain-language summary
The goal of this prospective, single-center, open-label, dose-escalation study is to evaluate the safety, tolerability, and preliminary efficacy of CD-001 in patients with advanced head and neck cancers who have experienced disease progression (PD) or intolerance to standard systemic therapy (or lack thereof). The main question\[s\] it aims to answer:
* What is the safety and tolerability profile of CD-001 across escalating doses?
* What is the preliminary efficacy of CD-001 in this patient population?
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years , regardless of gender.
. Patients with advanced head and neck cancer that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.
. ECOG score ≤ 2.
. At least one measurable lesion as defined by RECIST v1.1.
. Expected survival ≥ 3 months.
Exclusion criteria
. Patients with known active central nervous system (CNS) and/or leptomeningeal metastases .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients who have undergone major organ surgery within 4 weeks prior to the first dosing, or who are expected to require major surgery during this study, or who have severe unhealed wounds, trauma, ulcers, etc.
. Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant.
. Patients who have a past or current history of active or chronic autoimmune disease and who have required systemic therapy within the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease.
. Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing.
. At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.
. Patients with a history of ≥ Grade 3 (CTCAE) immune-related adverse events (irAEs) during prior anti-tumor therapy or permanent drug discontinuation due to irAEs.
. Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.