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.

Study Overview

• Status: Terminated
• Conditions: Advanced Malignant Neoplasm
• Intervention / Treatment: Drug: TQB2928 injection; Drug: Penpulimab

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230012
      • The Second People's Hospital of Hefei
    • Lu'an, Anhui, China, 237008
      • Lu'an People's Hospital of Anhui Province
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Science
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Gansu Provincial Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB2928 injection + Penpulimab; TQB2928 injection combined with Penpulimab, 21 days as a treatment cycle.	Drug: TQB2928 injection; Anti-CD47 monoclonal antibody; Drug: Penpulimab; Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Dose limiting toxicity (DLT)	The relevant adverse reactions occurred within the first cycle	Baseline up to 3 weeks

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TQB2928-AK105-Ib-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No