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

Not Applicable

Not yet recruiting

• Conditions: Malignant Neoplasm; Head &Amp; Neck Cancer; Head and Neck Cancer; Advanced Head and Neck Carcinoma
• Interventions: Drug: CD-001

• Registration Number: NCT07072325
• Lead Sponsor: West China Hospital

Brief 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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Submitted: 2025-07-30
• Last Update Posted: 2025-08-03
• Study Start: 2025-08-10
• Primary Completion: 2027-08-01
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Cohort	CD-001	CD-001 administered as an intravenous (lV) infusion

Primary Outcome Measures

Name	Time	Method
Adverse events	up to 12 months	Adverse events defined as the number of participants with adverse events according

Secondary Outcome Measures

Name	Time	Method
Overall Survival	up to 12 months	OS is defined as the time from the administration of the first dose to death.
Objective response rate	up to 12 months	ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Progress-Free Survival	up to 12 months	PFS is defined as the time from the administration of the first dose to first disease