Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy

NCT06008405 | Unknown Phase 1

• 1 other identifier: TQB2928-Ib-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 9

Brief Summary

This study carried out a phase Ib clinical trial of TQB2928 injection combined therapy in patients with hematological malignancies, to explore the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of TQB2928 injection combined with azacitidine for injection in Acute Myeloid Leukemia (AML)/Myelodysplastic Syndromes (MDS) subjects.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events (AEs)

  Adverse events refer to all adverse medical events that occur after patients receive the experimental drug, which can be manifested as symptoms, signs, diseases or abnormal laboratory tests, but do not necessarily have a causal relationship with the experimental drug. Evaluated by Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).

  Up to 2 years.

• Incidence of serious adverse events (SAEs)

  Incidence of serious adverse events (SAEs) evaluated by CTCAE 5.0.

  Up to 2 years.

• Severity of serious adverse events (SAEs)

  Severity of serious adverse events (SAEs) evaluated by CTCAE 5.0.

  Up to 2 years.

Secondary Outcomes (17)

• The area under the curve (AUC)

  Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.

• Peak concentration (Cmax)

  Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.

• Peak Time (Tmax)

  Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.

• Incidence of anti-drug antibody (ADA)

  Cycle1 Day1 and Cycle 5 Day 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; 90 days after last dose; Each cycle is 28 days.

• AML: Objective Response Rate (ORR)

  Up to 2 years.

Study Arms (1)

TQB2928 Injection + Azacitidine for injection

EXPERIMENTAL

Dose escalation: Intravenous infusion of TQB2928 Injection once a week, combined with azacitidine for injection (75 mg/m2, d1-7/q4w), 4 weeks (28 days) as a treatment cycle. Dose expansion: The maximum tolerated dose (MTD) or optimal biological dose (OBD) or recommended phase II dose (RP2D) determined in the dose-escalation phase is combined with azacitidine for injection for extended studies to further observe the safety and efficacy.

Drug: TQB2928 Injection + Azacitidine for injection

Interventions

TQB2928 Injection + Azacitidine for injection DRUG

TQB2928 injection is a fully humanized Immunoglobulin G 4 (IgG4) subtype monoclonal antibody targeting CD47. Azacitidine for injection is a nucleoside metabolism inhibitor that inhibits DeoxyriboNucleic Acid (DNA) methyltransferase, reduces DNA methylation and alters gene expression.

TQB2928 Injection + Azacitidine for injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily join this study, sign the informed consent form, and have good compliance;
• Age: age ≥ 18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2 points; expected survival time of more than 3 months;
• Subject population:
• The subjects were diagnosed with AML or MDS according to the World Health Organization (WHO) 2016 revised classification criteria for hematopoietic and lymphoid tissue tumors.
• MDS adopts the revised International Prognostic Scoring System (IPSS-R) \> 3.5 (higher risk group), and the proportion of bone marrow blasts ≥ 5%.
• Phase 1 (dose escalation phase) and Phase 2 (dose expansion phase) enrollment
• Untreated AML who cannot tolerate standard induction chemotherapy;
• Untreated higher-risk MDS;
• The main organs function well.
• Subjects must be willing to provide available diagnostic evidence or perform bone marrow aspiration and biopsy before the study treatment and must be willing to perform bone marrow aspiration and biopsy after receiving the study treatment.
• Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 7 days before study enrollment, and must be non-lactating subjects; male subjects should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.

You may not qualify if:

• Tumor disease and medical history:
• central nervous system leukemia;
• Other malignant tumors have occurred or are currently suffering from other malignant tumors within 3 years. The following two conditions can be included: other malignancies treated by a single surgery, achieving 5 years of continuous disease-free survival (DFS);
• Clinically significant uncontrolled pleural effusion, ascites, moderate or more remarkable pericardial effusion requiring repeated drainage.
• Previous anti-tumor therapy:
• Previous use of other drugs targeting the CD47/signal-regulatory protein α (SIRPα) signaling pathway;
• Received any antibody drug treatment under investigation within 4 weeks before the first administration, received Chimeric Antigen Receptor -T (CAR-T) therapy, or other immune cell therapy, or autologous hematopoietic stem cell transplantation 3 months before the first administration;
• Previously received allogeneic hematopoietic stem cell transplantation;
• Received any major surgery, chemotherapy and/or radiotherapy, immunotherapy or targeted therapy within 4 weeks before the first administration;
• The first administration is less than 5 drug half-lives from the previous oral targeted therapy (calculated from the end of the last treatment);
• Received Chinese patent medicines with anti-tumor indications within 2 weeks before the first administration, including compound mylabris capsules, Kangai injection, Kanglaite capsule/injection, Aidi injection, javanica oil, Xiao'ai ping tablet/injection, cinobufagin capsule, etc., (using symptomatic treatment such as hydroxyurea, leukocyte apheresis and erythropoietin and other hematopoietic growth factors within 7 days is allowed);
• Combined diseases and medical history:
• Liver abnormalities:
• Decompensated cirrhosis (Child-Pugh liver function grade B or C);
• Hepatitis B virus infection;

Sponsors & Collaborators

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

Study Sites (9)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Chongqing Hospital of Traditional Chinese Medicine

Chongqing, Chongqing Municipality, 400011, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

NOT YET RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

NOT YET RECRUITING

Shanghai Jiaotong University, School of Medicine, Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Azacitidine; Injections

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Weili Zhao, Doctor

CONTACT

+86 021-64150275; zwl_trail@163.com

Hongyan Tong, Doctor

CONTACT

+86 18120165251; tonghongyan@zju.edu.cn

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: August 18, 2023
• First Posted: August 23, 2023
• Study Start: September 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-03

Locations

CN (9)