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
Qualifiers
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
Treatments tested in this trial
- TQB2922 Subcutaneous Injection
Treatment groups
128 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov