A Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsule in Subjects With Advanced Malignant Tumors

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TQB3019, which comes in capsule form. The goal is to find out how safe the medication is, how well it is tolerated by patients, how it behaves in the body (pharmacokinetics), and if it shows any early signs of effectiveness in treating advanced malignant tumors, which are a type of serious cancer. The trial will take place at one location and involves two parts: first, testing different doses to find the best one, and second, giving a consistent dose to a larger group of participants.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of advanced cancer that has come back or is not responding to other treatments. They should have a good overall health status and be able to commit to the study requirements, including using contraception if they are of childbearing age. Participants will take TQB3019 capsules and will be monitored closely for any side effects and overall health during the study. It's important to note that this trial is not yet recruiting participants, so interested individuals will need to wait until it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
• • ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
• • Clearly diagnosed recurrent / refractory hematological tumors that meet the World Health Organization (WHO) definition;
• • At least 1 measurable lesion for efficacy evaluation.
• • The function of main organs is normal.
• • Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; a negative serum pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
• Exclusion Criteria:
• • Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\].
• • Subjects with central nervous system aggression (CNS);
• • Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or had active graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 12 months before the first dose;
• • Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);
• • Unrelieved toxicity of ≥CTC AE grade 1 due to any previous treatment, excluding alopecia and fatigue;
• • Major surgical treatment, open biopsy, and significant traumatic injury were received within 28 days before the start of study treatment.
• • The presence of active or uncontrolled primary autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP);
• • Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTC AE level 3 within 4 weeks before the first medication;
• • Subjects had an arteriovenous thrombosis event within 6 months.
• • Subjects have history of psychotropic substance abuse and are unable to abstain or have mental disorders;
• • Subjects with any severe and/or uncontrolled disease.
• • Within 2 weeks before the first treatment, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;
• • Previously received treatment with drugs similar to TQB3019 capsules;
• • Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (investigator judgment)
• • Study treatment related: subjects received live or messenger RNA (mRNA) vaccines within 4 weeks before the first treatment or were scheduled to receive live or mRNA vaccines during the study;
• • Participated in clinical trials of other antitumor drugs within 4 weeks before the first treatment;
• • According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons.