Treatment of Recurrent/Metastatic Head and Neck Cancer

Starting soon · Phase 1/Phase 2

Conditions studied: Recurrent/Metastatic Head and Neck Cancer

In brief

This study is a Phase Ib/II study of TQB2922 injection (subcutaneous). In the Phase Ib stage, a 3+3 dose-escalation design was used to determine the RP2D and pharmacokinetic characteristics of TQB2922 injection (subcutaneous) administered once every 3 weeks in subjects with R/M HNC. The Phase II stage explored the efficacy and safety of TQB2922 (subcutaneous) as monotherapy or in combination therapy in subjects with R/M HNC.

Key facts

Study ID

NCT07601204

Run by

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

People needed

128

Starts

2026-06-01

Expected to finish

2030-12-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject voluntarily enrolls in the study, signs the informed consent form, and has good compliance.
• Aged 18 to 75 years inclusive (calculated on the date of informed consent signing).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival > 12 weeks.
• Subjects with histologically or cytologically confirmed recurrent/metastatic head and neck cancer (R/M HNC) and no indication for curative local therapy.head and neck cancer (HNC)
• At least one measurable lesion per RECIST 1.1 criteria. If the target lesion is within the prior radiotherapy field, the lesion must be confirmed as progressive disease.
• Adequate major organ function, meeting the following laboratory criteria (no blood transfusion within 14 days prior to screening; no hematopoietic growth factors or other corrective medications administered within 7 days prior to screening):
• Hemoglobin (HGB) ≥ 90 g/L;
• Absolute neutrophil count (NEUT) ≥ 1.5×10⁹/L;
• Platelet count (PLT) ≥ 100×10⁹/L;
• Total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN); ≤ 2.0×ULN in subjects with liver metastasis;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; ≤ 5.0×ULN in subjects with liver metastasis;
• Creatinine clearance (CCR) ≥ 50 mL/min (calculated using the standard Cockcroft-Gault formula). For subjects not receiving platinum-containing chemotherapy, serum creatinine (Cr) ≤ 1.3×ULN is also acceptable.
• Serum albumin ≥ 30 g/L;
• Prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (in subjects not receiving anticoagulant therapy).
• Echocardiographic assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
• Females of childbearing potential agree to use effective contraception during the study and for 6 months after study completion; serum or urine pregnancy test must be negative within 7 days prior to enrollment. Males agree to use effective contraception during the study and for 6 months after study completion (see Section 5.5 for details).
• Additional criteria for Expansion Cohort 1 and Cohort 2:
• Has received at least one line of systemic therapy for recurrent/metastatic disease, including platinum-based chemotherapy and anti-programmed cell death protein 1 / programmed cell death ligand 1 (anti-PD-1/L1) therapy.
• Systemic therapy administered as part of multimodal treatment for locally advanced disease (including neoadjuvant/induction, concurrent, adjuvant/consolidation therapy), with disease recurrence or progression during chemotherapy/immunotherapy or within 6 months after the last dose, shall be defined as first-line chemotherapy/immunotherapy failure.
• No prior exposure to paclitaxel and its novel formulations (e.g., albumin-bound paclitaxel) (Cohort 2 only).
• Additional criteria for Expansion Cohort 3
• No prior systemic therapy for recurrent/metastatic disease. Systemic therapy as part of multimodal treatment for locally advanced disease (including induction/neoadjuvant therapy, concurrent systemic therapy with curative radiotherapy, adjuvant/consolidation therapy) is excluded, provided that the interval from completion of such therapy to disease recurrence/progression exceeds 6 months.

You may not qualify if…

• Current or history of other malignant tumors. The following two conditions are allowed for enrollment:
• Other malignant tumors treated with surgery alone with continuous 5-year disease-free survival (DFS); cured carcinoma in situ of cervix, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invading basement membrane)].
• Diseases that interfere with subcutaneous injection or venous blood collection.
• Adverse reactions from prior treatment have not recovered to ≤Grade 1 per CTCAE Version 6.0, except Grade 2 alopecia, Grade 2 peripheral neurotoxicity (Cohort 1 only), Grade 2 anemia, non-clinically significant asymptomatic Grade 2 laboratory abnormalities, hypothyroidism stabilized by hormone replacement therapy, and other toxicities deemed to have no safety risk by the investigator.
• Major surgical treatment, significant traumatic injury within 4 weeks prior to the first dose, or planned major surgery during the study treatment period (excluding protocol-specified surgeries); or unhealed wounds or fractures for a long time.
• Major surgery is defined as Grade 3 or above surgeries in the 2022 National Surgery Classification Catalogue.
• Any bleeding event ≥Grade 3 per CTCAE within 4 weeks prior to the first dose.
• Arterial/venous thromboembolic events within 6 months prior to the first dose, including cerebrovascular accidents (including transient ischemic attack, excluding lacunar cerebral infarction). Implantable venous port/catheter-related thrombosis or superficial venous thrombosis shall not be regarded as "severe" thromboembolism); deep venous thrombosis and pulmonary embolism.
• Active and poorly controlled viral hepatitis. Subjects meeting the following criteria may undergo screening:
• HBsAg-positive subjects must have Hepatitis B Virus Deoxyribonucleic Acid (HBV) DNA <500 IU/mL (or 2500 copies/mL), and agree to receive anti-HBV therapy throughout the study.
• HCV-infected subjects (HCV Ab or HCV RNA positive): HCV viral RNA ≤upper limit of normal, and continue approved antiviral therapy during the study.
• Active syphilis requiring treatment.
• Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia/radiation pneumonitis requiring treatment, active pneumonia with obvious clinical symptoms; history of interstitial lung disease (ILD) requiring previous treatment, or current interstitial lung disease.
• History of psychoactive substance abuse without abstinence, or mental disorders.
• Planned or prior allogeneic bone marrow transplantation or solid organ transplantation.
• History of hepatic encephalopathy.
• Severe cardiovascular diseases, including any of the following:
• Cardiac insufficiency ≥New York Heart Association (NYHA) Class II, or echocardiography showing left ventricular ejection fraction (LVEF) <50%.
• History of clinically significant ventricular arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes), or arrhythmia requiring continuous antiarrhythmic medication. Subjects with stable atrial fibrillation controlled by β-blockers alone may be enrolled after investigator's assessment.
• Unstable angina pectoris.
• Myocardial infarction within 12 months. Subjects who received interventional treatment more than 6 months ago without sequelae may be enrolled.
• Corrected QT interval (QTc): >450 ms in males, >470 ms in females. If QTc is abnormal, three consecutive measurements at an interval >2 minutes shall be performed and the average value adopted. Correction methods include Fridericia formula or Bazett formula.
• History or family history of congenital long QT syndrome.
• Active or uncontrolled severe infection (≥CTCAE Grade 2 infection).
• Renal failure requiring hemodialysis or peritoneal dialysis.

Where it is running

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• Guangxi Cancer InstituteGuangxi Cancer Hospital — Nanning, Guangxi, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Hubei Cancer Hospital — Wuhan, Hubei, China
• Hunan Cancer Hospital — Changsha, Hunan, China
• The First Hospital of China Medical University — Shenyang, Liaoning, China
• Shanxi Cancer hospital — Taiyuan, Shanxi, China
• West China Medical Center,Sichuan Medical University — Chengdu, Sichuan, China
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China

Full record on ClinicalTrials.gov

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