NCT06297642终止1 期
A Phase Ib Clinical Trial of TQB2928 Injection Combined With Penpulimab in the Treatment of Patients With Advanced Malignant Tumors.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 5
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in this study and sign informed consent;
- •Age: ≥18 years old (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) score: 0 or 2 point; The expected survival period exceeds 3 months;
- •Subject population: Histologically and/or cytologically confirmed advanced malignancies, including lymphomas and solid tumors.
- •Relapse or treatment failure after previous standard treatment, or intolerance to standard treatment and no other better treatment options：
- •Adequate treatment with PD-1/PD-L1 (including monotherapy or combination) without remission or disease progression after treatment.
- •Adequate main organs function
- •Female subjects of childbearing age should agree to use contraceptives (such as Intrauterine device, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine Pregnancy test was negative within 7 days before the study was included, and must be non-lactating subjects; Male participants should agree to use contraception during the study period and within 6 months after the end of the study period.
排除标准
- •Tumor disease and history:
- •Nodular lymphocyte dominant Hodgkin's lymphoma or gray area lymphoma.
- •The tumor involves the central nervous system.
- •People with a history of hemophagocytic syndrome or who have been assessed by the investigator as being at suspected risk.
- •Has experienced or currently suffers from other malignant tumors within 3 years.
- •Previous anti-tumor therapy:
- •Previous use of other similar drugs.
- •received systemic antitumor drugs (including drugs under investigation) within 4 weeks prior to initial administration, or received Chimeric Antigen Receptor T-cell (CAR-T) Therapy or Autologous hematopoietic stem cell transplantation( auto-HSCT) within 3 months prior to initial administration.
- •Previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- •any major surgical procedure, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to initial dosing.
- •Less than 5 drug half-lives between the first administration and the previous oral targeted therapy (calculated from the end time of the last therapy).
- •Received within 2 weeks before the first administration of Chinese patent drugs (including compound cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaiping tablet/injection, cinobufagin capsule, etc.) approved by the National Drug Administration (NMPA) with anti-tumor indications.
- •Concomitant diseases and medical history:
- •Liver abnormalities:
- •Abnormal kidney:
- •Cardiovascular and cerebrovascular abnormalities:
- •History of immune deficiency:
- •Lung diseases:
- •Active bacterial, fungal, or viral infections requiring systemic treatment.
- •Subjects with a history of hemolytic anemia from any cause (including Evans syndrome) or a positive Coombs test within 3 months prior to initial dosing.
- •A prior history of unexplained severe allergies, known to be allergic to monoclonal drugs or exogenous human immunoglobulins.
- •with a serious or poorly controlled disease that, in the judgment of the investigator and sponsor, poses a serious risk to the safety of the subjects or affects the completion of the study.
- •History of drug abuse or drug use.
- •Live attenuated vaccines were administered within 4 weeks before the first dose or during the planned study period. Inactivated Corona Virus Disease 2019 (COVID-19) and influenza vaccines are allowed.
- •Subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for enrollment for other reasons.
研究组 & 干预措施
TQB2928 injection + Penpulimab
Experimental
TQB2928 injection combined with Penpulimab, 21 days as a treatment cycle.
干预措施: TQB2928 injection (Drug)
TQB2928 injection + Penpulimab
Experimental
TQB2928 injection combined with Penpulimab, 21 days as a treatment cycle.
干预措施: Penpulimab (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: Baseline up to 3 weeks
The relevant adverse reactions occurred within the first cycle
Adverse event rate
时间窗: Baseline up to 96 weeks
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
次要结局
- Incidence of neutralizing antibodies(Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days))
- Overall survival (OS)(Baseline up to 96 weeks)
- Steady-state apparent volume of distribution (Vz/F)(Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.)
- Complete response rate (CRR)(Baseline up to 96 weeks)
- Disease Control Rate(Baseline up to 96 weeks)
- Duration of Response(Baseline up to 96 weeks)
- Incidence of Anti-Drug antibody(Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days))
- Minimum plasma concentration at steady state (Cmin,ss)(Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.)
- Objective response rate (ORR)(Baseline up to 96 weeks)
- The area under the plasma concentration time curve from zero to after 24h (AUC0-24h)(Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.)
- Receptor Occupancy (RO%)(day 1 and day 8 of Cycle 1, day 1 and day 15 of Cycle 2, 28 days after the last administration. (each cycle 21 days))
- Progression-free Survival(Baseline up to 96 weeks)
- Peak time (Tmax)(Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.)
- Peak concentration (Cmax)(Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.)
研究者
研究点 (5)
Loading locations...
相似试验
招募中
1 期
Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination TherapyMyelodysplastic SyndromesAcute Myeloid LeukemiaNCT06008405Chia Tai Tianqing Pharmaceutical Group Co., Ltd.48
尚未招募
1 期
Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung CancersAdvanced Non-small Cell Lung CancerNCT06585059Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.20
终止
1 期
Clinical Trial to Evaluate the Safety and Effectiveness of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell CarcinomaAdvanced Esophageal Squamous Cell CarcinomaNCT05834543Chia Tai Tianqing Pharmaceutical Group Co., Ltd.34
招募中
1 期
Clinical Trial of TQB2922 for Injection in Patients With Advanced CancersAdvanced CancerNCT06188624Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.150
招募中
1 期
A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell CarcinomaRecurrent Squamous Cell Carcinoma of the Head and NeckMetastatic Squamous Cell CarcinomaNCT05783921Chia Tai Tianqing Pharmaceutical Group Co., Ltd.60