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

NCT07072325 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025(666)
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Malignant Neoplasm; Head &Amp; Neck Cancer; Head and Neck Cancer; Advanced Head and Neck Carcinoma

Keywords

head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events defined as the number of participants with adverse events according

  up to 12 months

Secondary Outcomes (3)

• Objective response rate

  up to 12 months

• Progress-Free Survival

  up to 12 months

• Overall Survival

  up to 12 months

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

CD-001 administered as an intravenous (lV) infusion

Drug: CD-001

Interventions

CD-001 DRUG

CD-001 administered as an intravenous (lV)infusion.

Treatment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Related Publications (13)

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MeSH Terms

Conditions

Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Central Study Contacts

Xingchen Peng

CONTACT

+8618980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share