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NCT Number: NCT06188624

Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects 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

Chongqing University Cancer Hospital, Chongqing, Chongqing Municipality, 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

  • Subjects voluntarily join this study, sign the informed consent form, and have good compliance;
  • Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months;
  • Histologically or cytologically diagnosed with advanced cancers;
  • Subjects with advanced malignancies who have failed standard therapy or lack effective treatment;
  • Major organs are functioning well;
  • Female and male subjects of childbearing potential should agree to practice contraception during the study and until 6 months after the completion of the study.

Exclusion criteria

  • Current concomitant or ever presented with other malignancies within 2 years prior to the first dose;
  • Unresolved toxicity of Grade 1 or above according to CTCAE due to any prior anti-tumor therapy;
  • Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
  • Long-term unhealed wounds or fractures
  • Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
  • A history of psychotropic drug abuse and cannot be abstained, or have a mental disorder;
  • Subjects with any severe and/or uncontrolled disease;
  • History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
  • Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2922 for injection or its excipients;
  • According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.

Treatment and study plan

TQB2922 for injection

Drug

TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Time frame: During the first treatment cycle (28 days).

    DLT is defined as toxicities that meet pre-defined severity criteria according to the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 toxicity assessment criteria, and assessed as having a suspected relationship to study drug that occurred.

  2. Maximum tolerated dose (MTD)

    Time frame: During the first treatment cycle (28 days).

    MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

  3. Adverse events (AEs) rate

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

    The occurrence rate of all AEs during treatment

  4. Adverse events (AEs) severity

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

    The severity of all AEs occured during treatment

Secondary outcomes

  1. Half-life (T1/2)

    Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

    Terminal half-life (T1/2) after administration

  2. The area under the curve (AUC)

    Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

    The area under the curve (AUC) of blood concentration-time of TQB2922.

  3. Apparent plasma clearance (CL)

    Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

    Apparent plasma clearance of TQB2922.

  4. Apparent volume of distribution (Vz)

    Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

    The ratio of the amount of TQB2922 in the body to the blood concentration

  5. Minimum concentration (Cmin)

    Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

    Minimum observed concentration (Cmin) of TQB2922

  6. Objective response rate (ORR)

    Time frame: Up to 2 years.

    The percentage of patients with complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

  7. Duration of response (DOR)

    Time frame: Up to 2 years.

    The time from first documented response to documented disease progression.

  8. Progression-free survival (PFS)

    Time frame: Up to 2 years.

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

  9. Immunogenicity of TQB2922

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

    Immunogenicity of TQB2922 is assessed according to the 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

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

Industry

Registry information

Official study title

A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 3, 2024
Registry last updated
Apr 25, 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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