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 range18 Years
SexALL
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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 .
✕. 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.