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Status unknownNCT05198505Updated May 2, 2022

Clinical Trial of TQB2868 Injection in Subjects With Advanced Malignant Tumors

A Phase 1 interventional study of TQB2868 Injection in Advanced Malignant Tumor, sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. Status unknown at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-02.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
280
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The TQB2868 protein in this study targeted programmed cell death protein 1 (PD-1) and transforming growth factor-β (TGF-β). The bifunctional fusion protein targets and neutralizes TGF-β in the tumor microenvironment. On the basis of inhibiting PD-1 / programmed death ligand 1 (PD-L1) pathway, T cells can restore activity, enhance immune response, and more effectively improve the effect of inhibiting tumor occurrence and development.

02

Conditions studied

  • Advanced Malignant Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 280 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. is the lead sponsor of 53 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 1 Subjects voluntarily join the study and sign an informed consent form.
  • 2 Age: 18-75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance status (ECOG PS) score: 0\~1 points.
  • 3 Advanced malignant tumors clearly diagnosed by histology or cytology.
  • 4 Patients with advanced malignant tumors who have been diagnosed by tissue and/or cytology and have failed standard treatments or lack effective treatment options.
  • 5 The main organs are in good function, and the following examination results are good: routine blood examination, biochemical examination, blood coagulation function examination, heart color Doppler ultrasound evaluation.
  • 6 Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine within 7 days before study entry The pregnancy test is negative and must be a non-lactating subject; male subjects should agree that contraception must be used during the study period and within 6 months after the end of the study period.

Exclusion criteria

Exclusion Criteria:

  • 1 Combined diseases and medical history:

    1. Has had other malignant tumors within 3 years before the first medication. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieve disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
    2. Unrelieved toxic reactions higher than Common Terminology Criteria Adverse Events (CTC AE) level 1 or higher caused by any previous treatment, excluding hair loss;
    3. Major surgical treatment, obvious traumatic injury or long-term unhealed wounds or fractures have been received within 28 days before the first medication;
    4. Arterial/venous thrombosis occurred within 6 months before the first administration, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
    5. Existence of active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms;
    6. People who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
    7. Previous recipients of allogeneic bone marrow transplantation or solid organ transplantation.
    8. Subjects with any severe and / or uncontrolled disease.

  • 2 Tumor-related symptoms and treatment:

    1. Have received chemotherapy, radiotherapy or other anti-cancer therapies within 4 weeks before the first medication (the washout period will be calculated from the end of the last treatment); if you have received local radiotherapy in the past, you can join the group if the following conditions are met: End of radiotherapy more than 4 weeks from the start of the study treatment (brain radiotherapy is more than 2 weeks); and the target lesion selected for this study is not in the radiotherapy area; or the target lesion is located in the radiotherapy area, but progress has been confirmed.
    2. Received Chinese patent medicine treatment with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the first medication;
    3. Have previously received immunological double-antibody therapeutic drugs against the same target of TQB2868 injection;
    4. Uncontrollable pleural effusion, pericardial effusion or ascites that still needs to be drained repeatedly (investigator's judgment);
    5. Known to have spinal cord compression, cancerous meningitis, accompanied by brain metastasis symptoms, or symptom control time less than 2 weeks;

  • 3 Research and treatment related:

    1. The history of live attenuated vaccine vaccination within 28 days before the first administration or the planned live attenuated vaccine vaccination during the research period;
    2. Those who have had severe hypersensitivity reactions after using macromolecular drugs;
    3. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the first medication. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
    4. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose>10mg/day prednisone or other curative hormones), and continue within 2 weeks of the first administration in use;
  • 4 Participated in other anti-tumor drug clinical trials within 4 weeks before the first medication;
  • 5 According to the judgment of the researcher, there are situations that seriously endanger the safety of the subjects or affect the completion of the research by the subjects.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Experimental
    TQB2868 Injection

    The drug was administered once every 3 weeks (administration time window: ± 3 days), the dose of each administration was 1.5-600 mg, and 3 weeks was a treatment cycle until the disease progressed or the investigator judged that it was not suitable to continue the drug use.

    Drug: TQB2868 Injection

Interventions

  • DrugTQB2868 Injection

    TQB2868 protein is a bi-functional fusion protein targeting PD-1 and TGF-β

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    DLT definition: the subject has the following adverse events related to the test drug within one treatment cycle (21 days) after the first administration. 1. Grade ≥ 3 neutropenia with fever; Grade 4 neutropenia that cannot be recovered within 3 days after symptomatic treatment; Grade 3 anemia that cannot be recovered within 14 days; ≥ Grade 3 thrombocytopenia with bleeding; Other hematological toxicity above grade 4 (inclusive); 2. ≥ Grade 3 non hematological toxicity; Nausea, vomiting, diarrhea, rash and electrolyte disorder that cannot be recovered to grade ≤ 2 within 7 days after symptomatic treatment; Grade 3 general fatigue, fatigue and headache with duration ≥ 7 days; Laboratory examination abnormalities with isolated ≥ grade 3 and significant clinical symptoms; 3. Adverse events related to ≥ grade 3 infusion reaction occurred, and did not return to normal within 6 hours after stopping infusion

    Time frame: up to 10 months

  2. Recommended Phase II Dose (RP2D)

    To evaluate RP2D of TQB2868 injection in adult patients with advanced malignant tumors

    Time frame: up to 10 months

  3. Maximum Tolerated Dose (MTD)

    Defined as the highest dose when dose-limiting toxicity (DLT) occurred in less than 33% of subjects.

    Time frame: up to 10 months

  4. All adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)

    ncidence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)

    Time frame: up to 17 months

Secondary outcomes

  1. Time to reach maximum(peak )plasma concentration following drug administration (Tmax)

    To characterize the pharmacokinetics of TQB2868 by assessment of time to reach maximum plasma concentration after single and multiple dosing

    Time frame: up to 17 months

  2. Maximum (peak) plasma drug concentration (Cmax)

    Cmax is the maximum plasma concentration of TQB2868.

    Time frame: up to 17months

  3. Maximum (peak) steady-state plasma drug concentration during a dosage interval (Css-max)

    Cmax is the steady state maximum concentration of TQB2868 .

    Time frame: up to 17 months

  4. Title：The plasma concentration time curve at steady state, from 0 to τ area under curve of time. (AUC0-τ)

    To characterize the pharmacokinetics of TQB2868 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.

    Time frame: up to 17 months

  5. Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

    To characterize the pharmacokinetics of TQB2868 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.

    Time frame: up to 17 months

  6. Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)

    To characterize the pharmacokinetics of TQB2868 by assessment of area under the plasma concentration time curve from the first dose to infinity.

    Time frame: up to 17 months

  7. Apparent total clearance of the drug from plasma after oral administration (CL/F)

    CL/F is total clearance rate for TQB2868.

    Time frame: up to 17 months

  8. Elimination half-life (t1/2)

    t1/2 is time it takes for the blood concentration of TQB2868 to drop by half.

    Time frame: up to 17 months

  9. Apparent volume of distribution of intravenous infusion(Vss/F)

    Steady-state apparent volume of distribution of TQB2868 injection by intravenous infusion

    Time frame: up to 17 months

  10. Elimination rate constant(λ)

    λ is the elimination rate constant when TQB2868 participates in the calculation of metabolism in the body

    Time frame: up to 17 months

  11. Area under the plasma concentration-time curve from time zero to time 24h.( AUC0-24h)

    Characterize the pharmacokinetics of TQB2868 by evaluating the area under the plasma concentration-time curve from the first administration to 24h

    Time frame: up to 17 months

  12. Mean residence time (MRT)

    MRT describes the average time that TQB2868 remains in the body.

    Time frame: up to 17 months

  13. Minimum steady-state plasma drug concentration during a dosage interval (Css-min)

    Css-min is the minimum plasma concentration of TQB2868.

    Time frame: up to 17 months

  14. Degree of fluctuation(DF)

    DF is the volatility coefficient of TQB2868.

    Time frame: up to 17 months

  15. Average steady-state plasma drug concentration during multiple-dose administration (Css-avg)

    Css-avg is the average of steady-state plasma concentration of TQB2868 .

    Time frame: up to 17 months

  16. Anti-drug antibodies(ADA)

    ADA is antibodies that make TQB2868 clear in the body quickly

    Time frame: up to 17 months

  17. Receptor Occupancy(RO)

    RO is a receptor occupancy for TQB2868 involved in metabolism in the body

    Time frame: up to 17 months

  18. Progression-free survival (PFS)

    PFS is defined as the time from the first treatment to the first disease progression or death from any cause

    Time frame: up to 29 months

  19. Overall response rate (ORR)

    Percentage of participants achieving complete response (CR) and partial response (PR).

    Time frame: up to 29 months

  20. Disease control rate（DCR）

    Percentage of participants achieving CR and PR and stable disease (SD).

    Time frame: up to 29 months

  21. Duration of Response (DOR)

    The period from the participants first achieving CR or PR to disease progression.

    Time frame: up to 29 months

  22. Overall survival (OS)

    OS is defined as the time from the first administration to all-cause death.

    Time frame: up to 29 months

  23. PD-L1 expression in tumor tissue

    To evaluate the expression of PD -L1

    Time frame: up to 17 months

  24. TGF-β expression in blood samples

    To evaluate the expression of TGF-β

    Time frame: up to 17 months

07

Study locations

3 of 3 sites recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450003, China
    Recruiting
  • Linyi Cancer Hospital
    Linyi, Shandong 276002, China
    Recruiting
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai 200433, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05198505
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 20, 2022
Start date
Apr 27, 2022
Primary completion
Jun 2023 (estimated)
Completion
Jun 2024 (estimated)
Last update
May 2, 2022

Study contacts

Caicun Zhou, Doctor
Contact
caicunzhoudr@163.com
18796218833

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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