NCT07072325Not yet recruitingPhase 1
Safety, Tolerability, PK, and Efficacy of CD-001 in Advanced Head & Neck Cancers
A Clinical Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Head & Neck Cancers
Source: ClinicalTrials.gov · Last updated 3 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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?
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 10 Aug 2025
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- West China Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07072325
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From 10 Aug 2025 to the primary completion date, 1 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.
Other
- Patients with known active central nervous system (CNS) and/or leptomeningeal metastases .
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.