Safety, Tolerability, PK, and Efficacy of CD-001 in Advanced Head & Neck Cancers

Launched by WEST CHINA HOSPITAL · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called CD-001 to see if it is safe and well-tolerated in people with advanced head and neck cancers that have not responded to standard treatments or cannot tolerate them. The study will also look at whether CD-001 shows any early signs of helping to control the cancer. This is an early-phase trial, meaning the main focus is on safety and understanding the best dose to give.

People who may be eligible to join are adults aged 18 or older with advanced head and neck cancer that has been confirmed by tests, and who have either run out of standard treatment options or cannot tolerate those treatments. Participants need to be well enough to take part (able to perform daily activities with some limitations) and have at least one tumor that can be measured during the study. If eligible, participants will receive CD-001 at gradually increasing doses while being closely monitored for side effects and any signs the treatment might be working. Important to note, this trial is not yet recruiting, and some people with certain health issues—like active brain metastases, recent major surgery, or serious autoimmune diseases—may not be able to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years , regardless of gender.
• • 2. 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.
• • 3. ECOG score ≤ 2.
• • 4. At least one measurable lesion as defined by RECIST v1.1.
• • 5. Expected survival ≥ 3 months.
• Exclusion Criteria:
• • 1. Patients with known active central nervous system (CNS) and/or leptomeningeal metastases .
• • 2. 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.
• • 3. Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant.
• • 4. 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.
• • 5. Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing.
• • 6. At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.
• • 7. 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.
• • 8. Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.