Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Dose Escalation: intravenous (IV) infusion of TQB2928 as monotherapy

4 weekly IV infusions (Days 1, 8, 15, and 22) of TQB2928 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal.

TQB2928 Injection

TQB2928 is a promising new molecular entity that mediates blockade of CD47 and SIRPα and enhances the phagocytosis of cancer cells by macrophages. In preclinical in vivo models, TQB2928 was active against a wide range of solid tumors and hematologic malignancies. This is the first-in-human phase 1 trial of TQB2928 in patients with advanced solid tumors and hematological malignancies.

Phase 1 Trial of the TQB2928 Injection in Patients With Advanced Cancers

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TQB2928 Injection in Patients With Advanced Solid Tumors or Hematological Malignancies

DLTs will be assessed during the first 28 days of treatment for dose-escalation and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (28 days) of treatment.

MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).

Maximum observed concentration (Cmax) of TQB2928 after administration

Minimum observed concentration (Cmin) of TQB2928 at steady state

The area under the curve (AUC) of serum concentration of TQB2928

Number of patients who develop detectable anti-drug antibody (ADA), and percentage of ADA positive patients will be calculated to evaluate immunogenicity of TQB2928.

Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by iRECIST v1.1 criteria for solid tumors, Lugano2014 criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma, and AML IWG 2003 response criteria for acute myeloid leukemia (AML).

Defined as the proportion of subjects with CR, PR, or SD.

Defined as the time from first documented response to documented disease progression.

Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

weekly intravenous (IV) infusions for four times (Days 1, 8, 15, and 22) of TQB2928 in each 28-day treatment cycle

TQB2928 injection

weili Zhao, Doctor

li Zhang, Doctor

TQB2928 is a promising new molecular entity that mediates blockade of CD47 and SIRPα (Signal Regulatory Protein Alpha) and enhances the phagocytosis of cancer cells by macrophages. This is a study to evaluate the safety, tolerability and effectiveness of TQB2928 injection in subjects with advanced malignancies.

Clinical Trial of the TQB2928 Injection in Patients With Advanced Cancers

A Phase I Study of TQB2928 Injection in Patients With Advanced Cancers

DLT will be assessed during the first 28 days of treatment for dose-escalation and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (28 days) of treatment.

Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria for solid tumors, Lugano 2014 criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma, and acute myeloid leukemia (AML) IWG 2003 response criteria for AML.

Defined as the proportion of subjects with CR, PR, or SD (Stable Disease).

Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Percentage of ADA positive patients will be calculated to evaluate immunogenicity of TQB2928.

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

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

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

Penpulimab

Qingqing Cai, Doctor

Xiangyun Meng, Bachelor

Yong Huang, Bachelor

Feng Rong, Master

Ning Li, Doctor

Junfeng Jiang, Master

Yuhua Liu, Bachelor

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

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.

The relevant adverse reactions occurred within the first cycle

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

Percentage of participants achieve complete response and partial response

Percentage of participants achieve complete response

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

The time when the participants first achieved CR or PR to disease progression or death from any cause

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

From the first injection to the time of death from any cause.

The incidence of anti-drug antibody after administration of TQB2928 injection and penpulimab

The incidence of neutralizing antibodies after administration of TQB2928 injection and penpulimab

Area under the plasma concentration time curve from zero to after 24h for TQB2928.

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.

The minimum plasma concentration after stabilization

The extent to which antibody drugs occupy cell surface targets

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 1 Trial of the TQB2928 Injection in Patients With Advanced Cancers	NCT04854681	Advanced Solid ...	TQB2928 Injecti...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase 1 Trial of the TQB2928 Injection in Patients With Advanced Cancers	NCT04854681	Advanced Solid ...	TQB2928 Injecti...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Clinical Trial of the TQB2928 Injection in Patients With Advanced Cancers	NCT05192512	Advanced Cancer	TQB2928 injecti...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors.	NCT06297642	Advanced Malign...	TQB2928 injecti... Penpulimab	18 Years - 70 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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