Evaluating TQB2858 Injection for Patients with Terminal Malignant Tumors

A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant Tumor

This study is testing a new injection called TQB2858 to see if it is safe and tolerable for people with advanced cancer who have run out of other treatment options.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT04805060 on ClinicalTrials.gov

What this trial studies

This phase I study aims to assess the safety and tolerability of TQB2858 injection in patients suffering from advanced malignant tumors. The trial will involve patients whose standard treatments have failed or who have no effective treatment options available. Participants will be monitored for pharmacokinetics and any adverse reactions to the injection. The study focuses on individuals aged 18 to 75 with a life expectancy of more than three months and normal organ function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced malignancies that have not responded to standard treatments.

Not a fit: Patients with complicated disease histories or those who have developed other malignant tumors within the last two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with terminal malignant tumors who have exhausted other therapies.

How similar studies have performed: While this approach is novel, similar studies evaluating new treatments for terminal malignancies have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

* Patients with advanced malignancies diagnosed histologically and/or cytologically, where standard treatment has failed or there is no effective treatment;
* Age: 18-75 years old;
* ECOG score: 0 \~ 1;
* Expected survival of more than 3 months;
* The main organs are functioning normally;
* Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating;Patients should agree to use contraception during the study period and for 6 months after the study period.
* Patients voluntarily joined the study and signed the informed consent, showing good compliance.

Exclusion Criteria:

-Complicated disease and history: A) Has developed other malignant tumors within 2 years or is currently suffering from the same tumor; B) unmitigated toxic reactions above CTC AE grade 1 due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders; C) received major surgical treatment or significant traumatic injury (excluding needle biopsy) within 28 days prior to the commencement of study treatment; D) Long-term unhealed wounds or fractures; E) The occurrence of arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; F) People with a history of psychotropic substance abuse and inability to quit or with mental disorders; G) subjects with any severe and/or uncontrolled disease;"

-Tumor-related symptoms and treatment: A) had undergone surgery, chemotherapy, radiation or other anticancer therapy within 4 weeks prior to the start of study treatment (washout period was calculated from the end of the last treatment); B) Chinese patent drugs with anti-tumor indications specified in the NMPA approved drug specifications (including compound cantharide capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaoping tablet/injection, Huabenin capsule, etc.) were received within 2 weeks before the start of the study; C) previously received immunodouble antibody therapy targeting the same target of TQB2858 injection; D) uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator); E) Patients with brain metastases whose symptoms stabilized less than 4 weeks after discontinuation of dehydrants and steroids;"

-Research Treatment Related: A) a history of live attenuated vaccine vaccination within 28 days prior to the study treatment initiation or a planned live attenuated vaccine vaccination during the study period; B) Previous history of severe allergy to macromolecular drugs or known components of TQB2858 injection; C) Study the occurrence of active autoimmune disease requiring systemic treatment (e.g., use of palliative drugs, corticosteroids, or immunosuppressants) within 2 years prior to treatment initiation.Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic; D) have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy.(dose of \>10mg/ day prednisone or other equivalent efficacy hormone), and continued to use within 2 weeks of the first administration;" Participants had participated in other antitumor drug clinical trials in the previous 4 weeks;

-Subject who, in the Investigator's judgment, has a concomitant disease that seriously endangers the subject's safety or affects the completion of the study, or is considered unsuitable for inclusion for other reasons.

Where this trial is running

Changchun, Jilin

• Jinlin Cancer Hospital — Changchun, Jilin, China (RECRUITING)

Study contacts

• Study coordinator: Ying Cheng, Doctor

Conditions: Terminal Malignant Tumors