Clinical Trial of the TQB2928 Injection in Patients With Advanced Cancers

NCT05192512 | Unknown Phase 1

• 1 other identifier: TQB2928-I-02
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (9)

• Pharmacokinetics: 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

  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

  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)

  up to 2 years

• Disease control rate (DCR)

  up to 2 years

Study Arms (1)

TQB2928 injection

EXPERIMENTAL

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

Drug: TQB2928 injection

Interventions

TQB2928 injection DRUG

TQB2928 injection is a CD47 Blocker.

TQB2928 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Must have adequate organ and bone marrow function;
• 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;
• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
• Histologically or cytologically confirmed, locally advanced unresectable or metastatic solid tumors, or hematological malignancies, or lymphoma;
• 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;

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Sun Yat-sen University Cancer Cen

Guangzhou, Guangdong, 510060, China

RECRUITING

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Central Study Contacts

weili Zhao, Doctor

CONTACT

021-64150275; zwl_trial@163.com

li Zhang, Doctor

CONTACT

020-87343458; zhangli@sysucc.org.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: December 27, 2021
• First Posted: January 14, 2022
• Study Start: January 24, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

CN (2)