Treatment of Recurrent/Metastatic Head and Neck Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Any bleeding event ≥Grade 3 per CTCAE within 4 weeks prior to the first dose.
Trial design
Design model
Single group
Treatments tested in this trial
TQB2922 Subcutaneous Injection
DrugTQB2922 injection is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/Hepatocyte Growth Factor Receptor (c-Met).
Treatment groups
128 Participants
are divided into 1 treatment groupGroup A: TQB2922 Subcutaneous InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recommended Dose for Phase II (RP2D)
Recommended Dose for Phase II (RP2D)
Time frame
Through study completion, an average of 1 year2
Time to maximum concentration (Tmax)
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)3
Maximum concentration (Cmax)
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)4
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)
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)Secondary outcomes
1
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).
Time frame
The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient.2
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.
Time frame
The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient.3
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.
Time frame
The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient.4
Overall survival (OS)
The time from randomization to death due to any cause.
Time frame
From randomization until patient death, it is expected to be evaluated up to 5 years.Sponsors and contacts
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Source ClinicalTrials.gov
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