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Head and Neck Squamous Cell CarcinomaPhase 2NCT06508606

AK117 (Anti-CD47 mAb) Plus Cetuximab as Second-Line Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing AK117 + Cetuximab in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The administration of first-line pembrolizumab monotherapy or combined chemotherapy has been shown to improve survival among patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). However, over 80% of the patients still experience disease progression within a year. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
AK117 + Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Aug 2024to 1 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically or cytologically confirmed R/M HNSCC (including oral, oropharyngeal, hypopharyngeal, and laryngeal sites); Recurrence that cannot be cured by local treatment, and previous treatment with PD-1 (L1) inhibitors and/or platinum-based chemotherapy has failed.
  • At least one measurable lesion according to RECIST v1.1, excluding previously irradiated lesions unless clear progression occurred more than 3 months after the last radiotherapy;
  • Known HPV p16 status of oropharyngeal cancer;
  • Known PD-L1 expression status;
  • ECOG performance status of 0-1;
  • Expected survival ≥ 3 months;
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  • Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10^9/L); PLT ≥ 100,000/mcL (100 × 10^9/L) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;
  • Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g/L;
  • Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on anticoagulant therapy should have these laboratory indices closely monitored;
  • Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL/min calculated using the Cockcroft-Gault formula corrected for body surface area;
  • Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);
  • No severe organic heart disease or arrhythmias;
  • Women of childbearing potential (aged 15-49 years) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment;
  • Voluntary signed informed consent by the study participant.

Who cannot join

  • Participants who have received treatment with cetuximab in the first line.
  • Grade ≥2 peripheral neuropathy (according to CTCAE 5.0).
  • Anticipated need for surgery or any other form of systemic or local anti-tumor therapy during the study, including maintenance therapy or radiotherapy for head and neck squamous cell carcinoma (excluding palliative treatment for non-target lesions).
  • Received systemic chemotherapy within 3 weeks prior to first administration of study drug, received small molecule targeted therapy within 2 weeks prior to first administration or within 5 half-lives (whichever is longer), received anti-tumor biologic therapy, large molecule targeted therapy or immunotherapy within 4 weeks prior to first administration, or underwent major surgery (excluding minor surgery within 2 weeks with complete recovery); received radiotherapy within 14 days prior to first administration of study drug (excluding central nervous system radiotherapy which requires a washout period of ≥28 days).
  • Known active central nervous system metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate if stable, without progressive or new neurological deficits, seizures, evidence of increased intracranial pressure, vomiting, or headaches.
  • Lesions that are superficially ulcerated or have broken through at baseline.
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  • Residual toxicity from prior anti-tumor therapy (excluding alopecia, fatigue, and grade 2 hypothyroidism) or clinically significant laboratory abnormalities > grade 1 (CTCAE v5.0).
  • Pulmonary embolism or deep vein thrombosis within 3 months prior to first administration of study drug.
  • Known history of malignant tumors.
  • Any severe or uncontrolled systemic disease, including poorly controlled hypertension, diabetes.
  • History of active bleeding, coagulation disorder, or participants receiving coumarin anticoagulant therapy.
  • Known active hepatitis B or hepatitis C. Active hepatitis B is defined as known HBsAg positive and HBV DNA ≥500 IU/mL.
  • Concurrent severe, uncontrolled infections or known human immunodeficiency virus (HIV) (HIV antibody positive) infection, or diagnosis of acquired immune deficiency syndrome (AIDS); or poorly controlled autoimmune disease; or history of allogeneic tissue/organ transplant, stem cell or bone marrow transplant, or prior solid organ transplant.
  • Active bacterial, viral, fungal, rickettsial, or parasitic infections requiring systemic anti-infective therapy (unless treated and resolved before administration of study drug).
  • Received live virus vaccination within 30 days prior to first administration of study drug. Use of inactivated seasonal influenza vaccine or approved COVID-19 vaccine is allowed, with a washout period of >1 week prior to first administration of study drug.
  • History of or concurrent interstitial pneumonia, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm.
  • Received immunological therapy for any reason, including long-term use equivalent to >10 mg/day prednisone within 7 days prior to first administration of study drug or at any time during the study.
  • Uncontrolled pleural, peritoneal, pelvic effusion, or pericardial effusion requiring drainage ≥1 time per month.
  • Pregnancy test positive or breastfeeding participants. Women and men participants who do not plan to take adequate contraceptive measures within 180 days after the end of treatment.
  • Any other disease or clinically significant laboratory parameter abnormalities, severe medical or psychiatric condition, including substance abuse including alcohol abuse, which the investigator believes may compromise the safety of the participant, the integrity of the study, participant's ability to participate in the study, or interfere with the study objectives and result analysis.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

Other trials in China

About this study

Official title: A Study of AK117 (Anti-CD47 Monoclonal Antibody) in Combination With Cetuximab in Second-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The administration of first-line pembrolizumab monotherapy or combined chemotherapy has been shown to improve survival among patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). However, over 80% of the patients still experience disease progression within a year. Upon progression, treatment options are notably constrained, typically comprising methotrexate, docetaxel, and cetuximab. The median progression-free survivaland overall survival following chemotherapy, targeted therapy, or their combination are dismally low, ranging from 2-3 months and 6-8 months, respectively. The clinical trials CheckMate 141 and KEYNOTE 040 have led to the approval of Nivolumab and Pembrolizumab as second-line treatments for R/M HNSCC. Nevertheless, the response rates to immune monotherapy are limited, ranging from 10% to 35%. Even after receiving standard second-line immunotherapy, over 80% of patients encounter disease progression within 6 months, and more than 60% succumb to the disease within a year. Therefore, there is a dearth of a standardized treatment for R/M HNSCC after the failure of first- or second-line PD-1 (L1) inhibitors and/or platinum-based therapy

Being tested
AK117 + Cetuximab
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK117 + CetuximabDrug

    AK117: 45mg/kg (D1, IVGTT, Q3W); Cetuximab (initial dose 400mg/m2, subsequent doses of 250mg/m2, D1, QW) maintained until progression or intolerable toxicity occurred

Study groups in NCT06508606
Study groupRoleWhat they receive
AK117+CetuximabExperimentalPatients meeting the inclusion criteria were given AK117 45mg/kg (D1, IVGTT, Q3W) in combination with Cetuximab (initial dose 400mg/m2, subsequent doses of 250mg/m2, D1, QW) maintained until progression or intolerable toxicity occurred
Receives: Drug: AK117 + Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with Adverse Events (AEs)

    Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs

    Measured: Up to approximately 1 years

  2. OS

    overall survival

    Measured: Up to approximately 1 years

Secondary outcomes (4)

  1. ORR

    Objective response rate

    Measured: Up to approximately 1 years

  2. PFS

    Progression Free Survival

    Measured: Up to approximately 1 years

  3. DCR

    Disease control rate

    Measured: Up to approximately 1 years

  4. DoR

    Duration of Response

    Measured: Up to approximately 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start1 Aug 2024
  3. Primary completion1 Aug 2026
  4. Study completion1 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508606
Sponsor's protocol ID
20241106
Status last verified
Aug 2026
First submitted
12 Jul 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK117 + Cetuximab in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with Adverse Events (AEs) (time frame: Up to approximately 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06508606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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