Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers

A Phase I Study of TQB2102 Injection in Patients With Advanced Cancers

TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB102 injection in subjects with advanced malignancies.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: TQB2102 injection

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Cancer Hospital.
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun yat-sen University Cancer Center
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Medical University Cancer Hospital, Harbin, China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The First Affiliated Hospital of Nanjing Medical University
  • Liaoning
    • Shenyang, Liaoning, China, 11000
      • The First Hospital of China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China, 200092
      • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China Hospital, Sichuan University
    • Mianyang, Sichuan, China, 621000
      • Mianyang Central Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
• 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;
• Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumo;
• Malignant tumor that failed from standard treatment or had no standard treatment;
• According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
• The main organs function well;
• 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:

• Concurrent secondary malignancy or other malignancy with no evidence of disease for more than 3 years;
• History of uncontrolled intercurrent illness;
• Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
• Patients with known symptomatic brain metastases;
• Receiving any other investigational agent within 4 weeks before first dose;
• Patients with severe hypersensitivity after the use of monoclonal antibodies
• History of interstitial lung disease or pneumonia;
• 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: TQB2102 injection; intravenous infuse TQB2102 injection every three weeks, 21 days as a treatment cycle. (1.5mg/kg, 3mg/kg, 4.5mg/kg, 6mg/kg, 7.5mg/kg, 9mg/kg)	Drug: TQB2102 injection; TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a enzyme-cleavable linker, and a topoisomerase I inhibitor payload.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity (DLT)	DLT was defined as toxicities that meet pre-defined severity criteria (according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle (21 days) of treatment.	During the first treatment cycle (21 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.	During the first treatment cycle (21 days).
The occurrence rate of all adverse events (AEs)	The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)	From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.
Dose escalation: recommended phase 2 dose (RP2D)	The RP2D of DT-9081 is determined using pharmacokinetics, pharmacodynamics and safety data of the dose escalation part of the study.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline up to 2 years.
Disease control rate (DCR)	Defined as the proportion of subjects with CR, PR, or SD (Stable Disease).	Baseline up to 2 years.
Duration of Response (DOR)	Defined as the time from first documented response to documented disease progression.	Baseline to the date of documented disease progression, up to 2 years.
Progression-free survival (PFS)	Defined as the time from first documented response to documented disease progression.	Baseline to the date of documented disease progression, up to 2 years.
Overall survival(OS)	Overall survival refers to the time from the first treatment to death from any cause.	Baseline to the date of death from any cause, up to 2 years.
Immunogenicity	Incidence of anti-drug antibody (ADA)	Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days). 90 days after the end of the last infusion.
Area under the curve (AUC)	The area under the curve (AUC) of serum or plasma concentration of ADC drug, total antibody, and small molecule toxin.	Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days
Peak concentration (Cmax)	Maximum observed concentration (Cmax) of ADC drug, total antibody, and small molecule toxin.	Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days
Terminal half-life (T1/2)	Terminal plasma half-life is the time required to divide the plasma concentration by two.	Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): July 21, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TQB2102-I-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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