Not provided
Not provided
Not provided
Not provided
Not provided
Based on the current status of the same target research and the company's overall layout in the field of tumors, the early termination was determined after full communication with the principal investigator of the group leader unit.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2928 injection + Penpulimab | Experimental | TQB2928 injection combined with Penpulimab, 21 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2928 injection | Drug | Anti-CD47 monoclonal antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | The relevant adverse reactions occurred within the first cycle | Baseline up to 3 weeks |
| Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | Baseline up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Percentage of participants achieve complete response and partial response | Baseline up to 96 weeks |
| Complete response rate (CRR) | Percentage of participants achieve complete response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Tumor disease and history:
Previous anti-tumor therapy:
Concomitant diseases and medical history:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Hefei | Hefei | Anhui | 230012 | China | ||
| Lu'an People's Hospital of Anhui Province |
Not provided
| ID | Term |
|---|---|
| C000720860 | penpulimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Penpulimab |
| Drug |
Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1) |
|
| Baseline up to 96 weeks |
| Disease Control Rate | It is the proportion of patients whose tumors have shrunk or stabilized for a certain amount of time and includes complete response (CR), partial response (PR), and stable (SD) cases | Baseline up to 96 weeks |
| Duration of Response | The time when the participants first achieved CR or PR to disease progression or death from any cause | Baseline up to 96 weeks |
| Progression-free Survival | The period between the beginning of treatment and the observation of disease progression or death from any cause in a patient with a tumor disease | Baseline up to 96 weeks |
| Overall survival (OS) | From the first injection to the time of death from any cause. | Baseline up to 96 weeks |
| Incidence of Anti-Drug antibody | The incidence of anti-drug antibody after administration of TQB2928 injection and penpulimab | Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days) |
| Incidence of neutralizing antibodies | The incidence of neutralizing antibodies after administration of TQB2928 injection and penpulimab | Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days) |
| Peak time (Tmax) | The time to peak concentration | Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days. |
| Peak concentration (Cmax) | Maximum plasma drug concentration | Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days. |
| The area under the plasma concentration time curve from zero to after 24h (AUC0-24h) | Area under the plasma concentration time curve from zero to after 24h for TQB2928. | Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days. |
| Steady-state apparent volume of distribution (Vz/F) | The total volume of body fluid required by the measured plasma drug concentration after the total amount of drug in the body is to be balanced. | Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days. |
| Minimum plasma concentration at steady state (Cmin,ss) | The minimum plasma concentration after stabilization | Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days. |
| Receptor Occupancy (RO%) | The extent to which antibody drugs occupy cell surface targets | 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) |
| Lu'an |
| Anhui |
| 237008 |
| China |
| Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing Municipality | 100021 | China |
| Gansu Provincial Cancer Hospital | Lanzhou | Gansu | 730000 | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |