Treatment of Recurrent/Metastatic Head and Neck Cancer

NCT07601204 | Not Yet Recruiting Phase 1

• 1 other identifier: TQB2922-Ib/II-03
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Recurrent/Metastatic Head and Neck Cancer

Outcome Measures

Primary Outcomes (7)

• Recommended Dose for Phase II (RP2D)

  Recommended Dose for Phase II (RP2D)

  Through study completion, an average of 1 year

• Time to maximum concentration (Tmax)

  Time to maximum concentration (Tmax)

  0.5 hour before dosing, 4, 10, 24, 48, 72 hours after dosing on cycle 1 day 1, 0.5 hour before dosing on cycle 1 day 8, 0.5 hour before dosing on cycle 1 day 15, (each cycle is 21 days)

• Maximum concentration (Cmax)

  Maximum concentration (Cmax)

  0.5 hour before dosing, 4, 10, 24, 48, 72 hours after dosing on cycle 1 day 1, 0.5 hour before dosing on cycle 1 day 8, 0.5 hour before dosing on cycle 1 day 15, (each cycle is 21 days)

• Area under the concentration-time curve from time 0 to time t (AUC0-t)

  Area under the concentration-time curve from time 0 to time t (AUC0-t)

  0.5 hour before dosing, 4, 10, 24, 48, 72 hours after dosing on cycle 1 day 1, 0.5 hour before dosing on cycle 1 day 8, 0.5 hour before dosing on cycle 1 day 15, (each cycle is 21 days)

• Elimination half-life (t1/2)

  Elimination half-life (t1/2)

  0.5 hour before dosing, 4, 10, 24, 48, 72 hours after dosing on cycle 1 day 1, 0.5 hour before dosing on cycle 1 day 8, 0.5 hour before dosing on cycle 1 day 15, (each cycle is 21 days)

• Clearance (CL)

  Clearance (CL)

  0.5 hour before dosing, 4, 10, 24, 48, 72 hours after dosing on cycle 1 day 1, 0.5 hour before dosing on cycle 1 day 8, 0.5 hour before dosing on cycle 1 day 15, (each cycle is 21 days)

• Ctrough

  Ctrough

  0.5 hour before dosing, 4, 10, 24, 48, 72 hours after dosing on cycle 1 day 1, 0.5 hour before dosing on cycle 1 day 8, 0.5 hour before dosing on cycle 1 day 15, (each cycle is 21 days)

Secondary Outcomes (7)

• Overall response rate (ORR)

  The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient.

• Duration of response (DOR)

  The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient.

• Disease control rate (DCR)

  The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient.

• Overall survival (OS)

  From randomization until patient death, it is expected to be evaluated up to 5 years.

• Number of patients with adverse events (AEs) and serious adverse events (SAEs)

  Baseline up to 90 days after the last dose

Study Arms (1)

TQB2922 Subcutaneous Injection

EXPERIMENTAL

TQB2922 subcutaneous injection: During the first cycle, it is administered once a week, and subsequently it is administered once every three weeks, with one dose given in the morning.

Drug: TQB2922 Subcutaneous Injection

Interventions

TQB2922 Subcutaneous Injection DRUG

TQB2922 injection is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/Hepatocyte Growth Factor Receptor (c-Met).

TQB2922 Subcutaneous Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

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.

Sponsors & Collaborators

• Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (10)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangxi Cancer InstituteGuangxi Cancer Hospital

Nanning, Guangxi, 530012, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430023, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shanxi Cancer hospital

Taiyuan, Shanxi, 030000, China

Location

West China Medical Center,Sichuan Medical University

Chengdu, Sichuan, 610000, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Kunyu Yang, Doctor

CONTACT

13995595360; Yangky71@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-02

Locations

CN (10)