Clinical Trial of TQB2868 Injection in Subjects With Advanced Malignant Tumors

NCT05198505 | Unknown Phase 1

• 1 other identifier: TQB2868-I-01
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (4)

• 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

  up to 10 months

• Recommended Phase II Dose (RP2D)

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

  up to 10 months

• Maximum Tolerated Dose (MTD)

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

  up to 10 months

• 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)

  up to 17 months

Secondary Outcomes (24)

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

  up to 17 months

• Maximum (peak) plasma drug concentration (Cmax)

  up to 17months

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

  up to 17 months

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

  up to 17 months

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

  up to 17 months

Study Arms (1)

TQB2868 Injection

EXPERIMENTAL

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

TQB2868 Injection DRUG

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

TQB2868 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 join the study and sign an informed consent form.
• Age: 18-75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance status (ECOG PS) score: 0\~1 points.
• Advanced malignant tumors clearly diagnosed by histology or cytology.
• Patients with advanced malignant tumors who have been diagnosed by tissue and/or cytology and have failed standard treatments or lack effective treatment options.
• 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.
• 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.

You may not qualify if:

• Combined diseases and medical history:
• 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 \[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• Unrelieved toxic reactions higher than Common Terminology Criteria Adverse Events (CTC AE) level 1 or higher caused by any previous treatment, excluding hair loss;
• Major surgical treatment, obvious traumatic injury or long-term unhealed wounds or fractures have been received within 28 days before the first medication;
• 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;
• 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;
• People who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
• Previous recipients of allogeneic bone marrow transplantation or solid organ transplantation.
• Subjects with any severe and / or uncontrolled disease.
• Tumor-related symptoms and treatment:
• 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.
• 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;
• Have previously received immunological double-antibody therapeutic drugs against the same target of TQB2868 injection;
• Uncontrollable pleural effusion, pericardial effusion or ascites that still needs to be drained repeatedly (investigator's judgment);
• Known to have spinal cord compression, cancerous meningitis, accompanied by brain metastasis symptoms, or symptom control time less than 2 weeks;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (3)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, 276002, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

Caicun Zhou, Doctor

CONTACT

18796218833; caicunzhoudr@163.com

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: January 19, 2022
• First Posted: January 20, 2022
• Study Start: April 27, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

CN (3)