Recurrent/Metastatic Head and Neck CancerPhase 1/2NCT07601204
Treatment of Recurrent/Metastatic Head and Neck Cancer
A Phase 1/2 study testing TQB2922 Subcutaneous Injection in people with Recurrent/Metastatic Head and Neck Cancer, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent/Metastatic Head and Neck Cancer
- What is being tested?
- TQB2922 Subcutaneous Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 10 sitesChina
- Study dates
- Jun 2026to Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- History of immunodeficiency, including HIV positivity, or other acquired/congenital immunodeficiency diseases.
- Uncontrolled autoimmune diseases requiring immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes, and still requiring such treatment within 7 days prior to the first dose.
- Exclusion does not apply to subjects receiving prednisone <10 mg daily or equivalent dose of other corticosteroids.
- Epilepsy requiring treatment.
- Poorly controlled diabetes [fasting blood glucose (FBG)>10 mmol/L].
- Tumor-related conditions and prior therapies:
- Received chemotherapy, immunotherapy, small-molecule targeted therapy within 3 weeks prior to the first dose, or still within 5 half-lives of the drug (whichever is longer). The washout period is calculated from the date of the last treatment.
- Prior local radiotherapy is allowed if: radiotherapy completed >4 weeks prior to study treatment initiation (>2 weeks for brain radiotherapy); target lesion selected in this study is outside the radiotherapy field; or target lesion within radiotherapy field with confirmed progression.
- Received proprietary Chinese medicines with anti-tumor indications specified in National Medical Products Administration approved drug instructions within 1 week prior to the first dose (including Compound Mylabris Capsule, Kang'ai Injection, Kanglaite Capsule/Injection, Aidi Injection, Brucea Javanica Oil Injection/Capsule, Xiaoaiping Tablets/Injection, Huachansu Capsule, etc.).
- Imaging (CT/MRI) shows tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade major blood vessels and cause fatal massive hemorrhage during subsequent study treatment.
- Uncontrolled recurrent pleural effusion, pericardial effusion or moderate to severe ascites requiring repeated drainage (as assessed by investigator).
- Known spinal cord compression, meningeal metastasis/carcinomatous meningitis, brain metastasis with symptoms, or brain metastasis with symptomatic/radiographic control duration <4 weeks; still requiring steroids or dehydrating agents within 2 weeks prior to study treatment initiation.
- Subjects with newly diagnosed or progressive brain metastasis at screening shall be re-examined after at least 4 weeks to confirm stability.
- Known hypersensitivity to study drug or excipients.
- Received more than 2 lines of systemic therapy for recurrent/metastatic disease (Cohort 1 and Cohort 2).
- Prior treatment with EGFR-targeted antibodies/Antibody-Drug Conjugates (ADCs). Exclusion does not apply to subjects who received cetuximab or nimotuzumab during curative radiotherapy for locally advanced disease, with disease recurrence/progression occurring >6 months after completion of curative radiotherapy and the last dose.
- Prior treatment with more than one immune checkpoint inhibitor, or prior Transforming Growth Factor Beta targeted therapy (Cohort 3).
- Participated in another anti-tumor clinical trial and received investigational drugs within 4 weeks prior to the first dose.
- Conditions judged by the investigator to pose serious risks to subject safety or impair completion of the study.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Junlin Yi, Doctor, 13661217998, yijunlin1969@163.com
Hunan Cancer Hospital
Changsha, Hunan, 410013
JinGuan Lin, Master, 13307318568, linjinguan@hnca.org.cn
West China Medical Center,Sichuan Medical University
Chengdu, Sichuan, 610000
Lei Liu, Doctor, 18980606231, clinical_liu66@163.com
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhiming Li, Doctor, 13719189172, lzmlzmlzm@yahoo.com
Guangxi Cancer InstituteGuangxi Cancer Hospital
Nanning, Guangxi, 530012
Song Qu, Doctor, 13607887386, 13607887386@163.com
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Qiao Qiao, Doctor, 13889368446, qiaojiang120@126.com
Shanxi Cancer hospital
Taiyuan, Shanxi, 030000
Ruyuan Guo, Master, 13513649615, 921231394@qq.com
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Peiguo Wang, Doctor, 18622221196, wangpeiguo@tjmuch.com
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430023
Kunyu Yang, Doctor, 13995595360, Yangky71@aliyun.com
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Jian Chen, Master, 18971493507, Chenjian2003@aliyun.com
About this study
Official title: Phase Ib/II Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of TQB2922 Injection (Subcutaneous) in the Treatment of Recurrent/Metastatic Head and Neck Cancer
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.
- Being tested
- TQB2922 Subcutaneous Injection
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2922 Subcutaneous InjectionDrug
TQB2922 injection is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/Hepatocyte Growth Factor Receptor (c-Met).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TQB2922 Subcutaneous Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Dose for Phase II (RP2D)
Recommended Dose for Phase II (RP2D)
Measured: Through study completion, an average of 1 year
Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
After enrollment of all patients, the proportion of participants with the best overall efficacy rated as complete response or partial response according to criteria (RECIST1.1).
Measured: 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)
Patient from the date of first documentation of objective remission of the tumor to the date of first documentation of objective progression of the tumor or the date of death due to any cause.
Measured: 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)
Proportion of participants with complete response, partial response, and stable disease as rated by RECIST v1.1 criteria for best overall efficacy after enrollment of all patients.
Measured: The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient.
Overall survival (OS)
The time from randomization to death due to any cause.
Measured: 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)
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Baseline up to 90 days after the last dose
Severity of AE/SAE
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Baseline up to 90 days after the last dose
Immunogenicity indicators: anti-drug antibodies (ADA)
Usually refers specifically to antidrug-binding antibodies.
Measured: Day 1 of cycles 1, 2, 4, 6, and 8 (within 30 minutes before administration, end of treatment follow-up (EOT), 90 days after the last administration).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/Metastatic Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601204
- Sponsor's protocol ID
- TQB2922-Ib/II-03
- Status last verified
- Feb 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of TQB2922 Injection (Subcutaneous) in the Treatment of Recurrent/Metastatic Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07601204
- Acronym / sponsor ID
- TQB2922-Ib/II-03
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2922 Subcutaneous Injection | Experimental | Drug: TQB2922 Subcutaneous InjectionTQB2922 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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)
Key exclusion criteria (44 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2922 Subcutaneous InjectionTQB2922 injection is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/Hepatocyte Growth Factor Receptor (c-Met). | Drug | TQB2922 Subcutaneous Injection |
Primary outcome
Recommended Dose for Phase II (RP2D)
Time frame: Through study completion, an average of 1 year
Recommended Dose for Phase II (RP2D)
Time to maximum concentration (Tmax)
Time frame: 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)
Time to maximum concentration (Tmax)
Maximum concentration (Cmax)
Time frame: 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)
Area under the concentration-time curve from time 0 to time t (AUC0-t)
Time frame: 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)
Elimination half-life (t1/2)
Time frame: 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)
Clearance (CL)
Time frame: 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)
Ctrough
Time frame: 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
7 secondary outcomes
Overall response rate (ORR)
Time frame: 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)
Time frame: 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)
Time frame: The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient.
Overall survival (OS)
Time frame: 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)
Time frame: Baseline up to 90 days after the last dose
Severity of AE/SAE
Time frame: Baseline up to 90 days after the last dose
Immunogenicity indicators: anti-drug antibodies (ADA)
Time frame: Day 1 of cycles 1, 2, 4, 6, and 8 (within 30 minutes before administration, end of treatment follow-up (EOT), 90 days after the last administration).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB2922 Subcutaneous Injection in people with Recurrent/Metastatic Head and Neck Cancer, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 10 sites 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 23 inclusion and 44 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kunyu Yang, Doctor (13995595360, Yangky71@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Dose for Phase II (RP2D) (time frame: Through study completion, an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.