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

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

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

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.