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NCT Number: NCT07260708

Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects voluntarily joined this study, signed the informed consent form, and had good compliance;
  • 18-75 yeas old;
  • Eastern Cooperative Oncology Group Performance Status (ECOG) score: 0-1;
  • Expected survival of more than 12 weeks;
  • Histologically or cytologically diagnosed with advanced non-squamous non-small cell lung cancer
  • Subjects in the monotherapy introduction stage need to have received standard treatment or lack effective treatment.
  • There must be at least one measurable lesion within the radiotherapy area that can be clearly classified as progressive according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) criteria.
  • Major organs are functioning well;
  • Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.

Exclusion criteria

  • Current concomitant presence of other malignancies within 5 years prior to the first dose;
  • At the time of initiating the study of treatment, the adverse reactions caused by previous anti-tumor treatments failed to recover to a CTCAE 5.0 score of grade 1 or below.
  • Patients who had received major surgical treatment within 4 weeks prior to the first study, had obvious traumatic injuries, or were expected to undergo major surgery during the study treatment period, or had long-term unhealed wounds or fractures.
  • Hyperactive or venous thrombosis events occurred within 6 months before the first administration;
  • Major cardiovascular diseases;
  • Active hepatitis
  • Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders.
  • There was an active infection (≥ Common Terminology Criteria for Adverse Events version 5.0 (CTCAE5.0) score of grade 2) within 2 weeks before the first administration;
  • Patients with renal failure requiring hemodialysis or peritoneal dialysis;
  • Patients who have a history of immune deficiency.
  • Patients who have epilepsy and need treatment;
  • Evidence of a previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any clinically active interstitial lung disease.
  • Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first treatment.
  • Pregnant or lactating women.
  • There is any serious or uncontrolled systemic disease.

Treatment and study plan

TQB2922 injection (subcutaneous injection)

Drug

TQB2922 is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/c-Met.

Primary outcomes

  1. Time to Peak Concentration

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    Time to Peak Concentration

  2. Peak concentration

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    Maximum plasma drug concentration

  3. half-life (T1/2)

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    Terminal half-life (T1/2)

  4. The area under the curve (AUC0-∞)

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    The area under the plasma concentration-time curve extrapolated from the first administration to infinity

  5. The area under the curve (AUC0-t)

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    The area under the plasma concentration-time curve from the time of the first administration to the last quantifiable concentration time point.

  6. Elimination Rate

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    Reflects the rate at which a drug disappears from the bloodstream

  7. Apparent Oral Clearance

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    The mixed effect reflecting the drug's clearance ability and absorption degree.

  8. Apparent Volume of Distribution

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    The mixed effect reflecting the degree of drug distribution and absorption.

  9. Trough Concentration

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    The blood drug concentration at the moment before the next administration.

  10. Accumulation Ratio

    Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

    The ratio of the drug exposure at a steady state to the drug exposure after the first administration.

Secondary outcomes

  1. Adverse Events (AE) rate

    Time frame: From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first

    The occurrence and severity of all AEs

  2. Objective Response Rate (ORR)

    Time frame: 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

  3. Duration of Response (DOR)

    Time frame: Up to 3 years

    Defined as the time from first documented response to documented disease progression.

  4. Progression-free survival (PFS)

    Time frame: Up to 3 years

    Defined as the time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause.

  5. Incidence of anti-drug antibody (ADA)

    Time frame: From the time of informed consent signed through 90 days after the last dose.

    Incidence of anti-drug antibody (ADA)

Study contacts

Contact information is provided by the study sponsor or research team.

Li Zhang, Doctor

CONTACT

[email protected]

020-87343458

Sponsors and collaborators

Lead sponsor

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Study to Evaluate The Safety and Pharmacokinetics of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 3, 2025
Registry last updated
Apr 21, 2026

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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