TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors.

Advanced Malignant Neoplasm Clinical Trial

Official title:

A Phase Ib Clinical Trial of TQB2928 Injection Combined With Penpulimab in the Treatment of Patients With Advanced Malignant Tumors.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297642
• Other study ID #: TQB2928-AK105-Ib-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: March 2028

Study information

• Verified date: March 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Qingqing Cai, Doctor
• Phone: 18376665396
• Email: caiqq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: March 2028
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Tumor disease and history:

1. Nodular lymphocyte dominant Hodgkin's lymphoma or gray area lymphoma.

2. The tumor involves the central nervous system.

3. People with a history of hemophagocytic syndrome or who have been assessed by the investigator as being at suspected risk.

4. Has experienced or currently suffers from other malignant tumors within 3 years.

• Previous anti-tumor therapy:

1. Previous use of other similar drugs.

2. 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.

3. Previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

4. any major surgical procedure, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to initial dosing.

5. 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).

6. 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:

1. Liver abnormalities:

2. Abnormal kidney:

3. Cardiovascular and cerebrovascular abnormalities:

4. History of immune deficiency:

5. Lung diseases:

6. Active bacterial, fungal, or viral infections requiring systemic treatment.

7. 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.

8. A prior history of unexplained severe allergies, known to be allergic to monoclonal drugs or exogenous human immunoglobulins.

9. 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.

10. 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.

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• TQB2928 injection
Anti-CD47 monoclonal antibody
• Penpulimab
Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Gansu Provincial Cancer Hospital	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)	The relevant adverse reactions occurred within the first cycle	Baseline up to 3 weeks
Primary	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
Secondary	Objective response rate (ORR)	Percentage of participants achieve complete response and partial response	Baseline up to 96 weeks
Secondary	Complete response rate (CRR)	Percentage of participants achieve complete response	Baseline up to 96 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall survival (OS)	From the first injection to the time of death from any cause.	Baseline up to 96 weeks
Secondary	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)
Secondary	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)
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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)