Clinical Trial of the TQB2930 Injection in Patients With Advanced Cancers

A Phase I Study of TQB2930 Injection in Patients With Advanced Cancers

TQB2930 is an anti-HER2 (Human Epidermal Growth Factor Receptor 2) bispecific antibody that can simultaneously bind two epitopes of HER2, leading to a dual HER2 signal blockage. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB2930 injection in subjects with advanced malignancies.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancers
• Intervention / Treatment: Drug: TQB2930 injection

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ruihua Xu, Doctor; Phone Number: 86-20-87343468; Email: ruihxu@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Ruihua C Xu; Phone Number: +862087343468; Email: ruihxu@163.com

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 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
• 2 Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;
• 3 Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;
• 4 Malignant tumor that failed from standard treatment or had no standard treatment;
• 5 According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
• 6 The main organs function well;
• 7 Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Exclusion Criteria:

• 1 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years;
• 2 History of uncontrolled intercurrent illness;
• 3 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
• 4 Patients with known symptomatic brain metastases;
• 5 Receiving any other investigational agent within 4 weeks before first dose;
• 6 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: TQB2930 injection; Drug:Weekly intravenous infusion of TQB2930 injection,21 days as a treatment cycle. (2.5mg/kg, 5mg/kg, 10mg/kg) Drug:Every two weeks intravenous infusion of TQB2930 injection , 28 days as a treatment cycle.(20mg/kg) Drug:Every three weeks intravenous infusion of TQB2930 injection, 21 days as a treatment cycle. (30mg/kg)	Drug: TQB2930 injection; TQB2930 is an anti-HER2 bispecific antibody.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity (DLT)	DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle.	At the end of Cycle 1 (each cycle is 21 or 28 days)
Maximum tolerated dose (MTD)	MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.	At the end of Cycle 1 (each cycle is 21 or 28 days).
Adverse events (AE) rate	The occurrence and severity of all AEs	From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immunogenicity	Incidence of anti-drug antibody (ADA)	Cycle 1 Day 1, Cycle 2 Day1, Cycle 4 Day1, Cycle 7 Day1, Cycle 12 Day1: pre-dose and end of the infusion.(each cycle is 21 or 28 days)
Pharmacokinetics: The area under the curve (AUC)	The area under the curve (AUC) of serum concentration of TQB2930	Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.(21 or 28 days each)
Pharmacokinetics:Peak concentration (Cmax)	Maximum observed concentration (Cmax) of TQB2930	Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each
Pharmacokinetics: T1/2	Terminal half-life (T1/2)	Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each
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	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
Disease control rate (DCR)	Defined as the proportion of subjects with CR, PR, or SD (Stable Disease).	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
Duration of Response (DOR)	Defined as the time from first documented response to documented disease progression.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
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.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
Overall survival(OS)	Overall survival refers to the time from the first treatment to death from any cause.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TQB2930-I-01

Drug and device information, study documents

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