Clinical Trial of the TQB2928 Injection in Patients With Advanced Cancers

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: TQB2928 injection

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: weili Zhao, Doctor; Phone Number: 021-64150275; Email: zwl_trial@163.com
• Study Contact Backup: Name: Li Zhang, Doctor; Phone Number: 020-87343458; Email: zhangli@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Cen
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1 Male or female patient ≥18 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;
• 2 Must have adequate organ and bone marrow function;
• 3 Pregnancy test (for females of childbearing potential) negative within 7 days before first dose. Male and female patients of childbearing potential and at risk for pregnancy must agree to use highly effective method(s) of contraception throughout the study and for at least 6 months after the last dose of assigned treatment;
• 4 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
• 5 Histologically or cytologically confirmed, locally advanced unresectable or metastatic solid tumors, or hematological malignancies, or lymphoma;
• 6 Solid tumors or hematological malignancies that failed from standard therapy, or lymphoma patients who have had at least two regimens of systemic therapy failures, or who refused other systemic therapy;

Exclusion Criteria:

• 1 Patients with known symptomatic brain metastases
• 2 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years
• 3 Uncontrolled pleural effusion or pericardial effusion with clinical significance and require repeated drainage as assessed by the Investigators
• 4 Prior treatment with monospecific or bispecific antibodies or fusion proteins targeting CD47 or signal regulatory protein alpha (SIRPα)
• 5 Therapeutic or experimental antibodies within 3 months prior to first dose
• 6 Approved tyrosine kinase inhibitor (TKI) therapy within less than 5 half-lives prior to enrollment.
• 7 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 3 months prior to first dose;
• 8 Liver abnormalities including hepatitis B (HBV) and hepatitis C (HCV).
• 9 History of hemolytic anemia or Evans syndrome within 3 months.
• 10 Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.

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; weekly intravenous (IV) infusions for four times (Days 1, 8, 15, and 22) of TQB2928 in each 28-day treatment cycle	Drug: TQB2928 injection; TQB2928 injection is a CD47 Blocker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose (MTD)	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).	During the first 28 days
Dose Limiting Toxicity (DLT)	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.	During the first 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	Defined as the time from first documented response to documented disease progression.	up to 2 years
Progression-free survival (PFS)	Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.	up to 2 years
Pharmacokinetics: T1/2	Terminal half-life (T1/2)	Cycle 1 Day 1 and Cycle 1 Day 22: pre-dose, and 0.08, 2, 6, 24 and 72 hours after infusion. Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1: pre-dose and end of the infusion. Each cycle is 28days.
Pharmacokinetics: AUC	The area under the curve (AUC) of serum concentration of TQB2928	Cycle 1 Day 1 and Cycle 1 Day 22: pre-dose, and 0.08, 2, 6, 24 and 72 hours after infusion. Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1: pre-dose and end of the infusion. Each cycle is 28days.
Pharmacokinetics: Cmin	Minimum observed concentration (Cmin) of TQB2928 at steady state	Cycle 1 Day 1 and Cycle 1 Day 22: pre-dose, and 0.08, 2, 6, 24 and 72 hours after infusion. Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1: pre-dose and end of the infusion. Each cycle is 28days.
Objective Response Rate (ORR)	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.	up to 2 years
Disease control rate (DCR)	Defined as the proportion of subjects with CR, PR, or SD (Stable Disease).	up to 2 years
Number of patients with adverse events (AEs) and serious adverse events (SAEs)	Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	From the time of informed consent signed to 90 days after the last dose
Percentage of anti-drug antibody (ADA) positive patients	Percentage of ADA positive patients will be calculated to evaluate immunogenicity of TQB2928.	From the time of informed consent signed through 90 days after the last dose.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TQB2928-I-02

Drug and device information, study documents

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