Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers

July 29, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
219

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ruihua Xu, Doctor
  • Phone Number: +86-20-87343468
  • Email: ruihxu@163.com

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicity (DLT)
Time Frame: During the first treatment cycle (21 days).
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)
Time Frame: During the first treatment cycle (21 days).
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)
Time Frame: From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.
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)
Time Frame: Up to 2 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Baseline up to 2 years.
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)
Time Frame: Baseline up to 2 years.
Defined as the proportion of subjects with CR, PR, or SD (Stable Disease).
Baseline up to 2 years.
Duration of Response (DOR)
Time Frame: Baseline to the date of documented disease progression, up to 2 years.
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)
Time Frame: Baseline to the date of documented disease progression, up to 2 years.
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)
Time Frame: Baseline to the date of death from any cause, up to 2 years.
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
Time Frame: 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.
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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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