Phase Ib Clinical Trial of TQB2928 Injection Combination Therapy in Patients With Hematological Malignancies

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.9 sites in 1 country48 target enrollmentSeptember 2023

ConditionsAcute Myeloid Leukemia Myelodysplastic Syndromes

InterventionsTQB2928 Injection + Azacitidine for injection

DrugsTQB2928 Injection + Azacitidine for injection

Overview

Phase: Phase 1
Intervention: TQB2928 Injection + Azacitidine for injection
Conditions: Acute Myeloid Leukemia
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 48
Locations: 9
Primary Endpoint: Incidence of serious adverse events (SAEs)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2023

End Date

May 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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);

Arms & Interventions

TQB2928 Injection + Azacitidine for injection

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.

Intervention: TQB2928 Injection + Azacitidine for injection

Outcomes

Primary Outcomes

Incidence of serious adverse events (SAEs)

Time Frame: Up to 2 years.

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

Incidence of Adverse Events (AEs)

Time Frame: Up to 2 years.

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).

Severity of serious adverse events (SAEs)

Time Frame: Up to 2 years.

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

Secondary Outcomes

MDS: Objective Response Rate (ORR)(Up to 2 years.)
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.)
AML: Time to CR+CRh+CRi(Up to 2 years.)
AML: Event-free survival (EFS)(Up to 2 years.)
MDS: Improvement in Transfusion Independence(Up to 2 years.)
MDS: Complete Response (CR) Rate(Up to 2 years.)
MDS: Progression Free Survival (PFS)(Up to 2 years.)
MDS: Change from Baseline in Quality of Life (QoL) Score(Up to 2 years.)
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.)
AML: Duration of Response (DOR)(Up to 2 years.)
AML: Relapse-Free Survival (RFS)(Up to 2 years.)
AML: Overall survival (OS)(Up to 2 years.)
MDS: Leukemia-free survival(Up to 2 years.)
MDS: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue(Up to 2 years.)
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.)