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

NCT07260708 | Recruiting Phase 1

• 1 other identifier: TQB2922-I-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Advanced Cancers

Outcome Measures

Primary Outcomes (10)

• Time to Peak Concentration

  Time to Peak Concentration

  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)

• Peak concentration

  Maximum plasma drug concentration

  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)

• half-life (T1/2)

  Terminal half-life (T1/2)

  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 curve (AUC0-∞）

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

  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 curve (AUC0-t)

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

  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)

• Elimination Rate

  Reflects the rate at which a drug disappears from the bloodstream

  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)

• Apparent Oral Clearance

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

  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)

• Apparent Volume of Distribution

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

  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)

• Trough Concentration

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

  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)

• Accumulation Ratio

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

  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)

Secondary Outcomes (5)

• Adverse Events (AE) rate

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

• Objective Response Rate (ORR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 3 years

• Progression-free survival (PFS)

  Up to 3 years

• Incidence of anti-drug antibody (ADA)

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

Study Arms (1)

TQB2922 injection (subcutaneous injection)

EXPERIMENTAL

TQB2922 injection (Subcutaneous Injection), 28 days as a treatment cycle

Drug: TQB2922 injection (subcutaneous injection)

Interventions

TQB2922 injection (subcutaneous injection) DRUG

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

TQB2922 injection (subcutaneous injection)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (11)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

West China hospital, Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Chengdu Third People's Hospital

Chengdu, Sichuan, 610100, China

NOT YET RECRUITING

MeSH Terms

Interventions

Injections, Subcutaneous

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Li Zhang, Doctor

CONTACT

020-87343458; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2025-09

Locations

CN (11)