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NCT Number: NCT05735496

Clinical Trial of the 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fujian Cancer Hospital., Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TQB2102 Injection

Drug

TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a enzyme-cleavable linker, and a topoisomerase I inhibitor payload.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Disease control rate (DCR)

    Time frame: Baseline up to 2 years.

    Defined as the proportion of subjects with CR, PR, or SD (Stable Disease).

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Feb 21, 2023
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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