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

NCT06297642 | Terminated Phase 1

• 1 other identifier: TQB2928-AK105-Ib-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (14)

• Objective response rate (ORR)

  Baseline up to 96 weeks

• 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

• Progression-free Survival

  Baseline up to 96 weeks

Study Arms (1)

TQB2928 injection + Penpulimab

EXPERIMENTAL

TQB2928 injection combined with Penpulimab, 21 days as a treatment cycle.

Drug: TQB2928 injection; Drug: Penpulimab

Interventions

TQB2928 injection DRUG

Anti-CD47 monoclonal antibody

TQB2928 injection + Penpulimab

Penpulimab DRUG

Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)

TQB2928 injection + Penpulimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

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

Study Sites (5)

The Second People's Hospital of Hefei

Hefei, Anhui, 230012, China

Location

Lu'an People's Hospital of Anhui Province

Lu'an, Anhui, 237008, China

Location

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, 730000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

penpulimab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: May 24, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-01

Locations

CN (5)