TQB3019 capsules: TQB3019 capsule is a targeted protein degrader
Study summary
The trial was divided into two phases: dose escalation and dose expansion. The dosing regimens were single-dose study and continuous dosing study. A single-center, open, non-randomized, single-arm clinical trial design was adopted. Subjects with advanced malignant tumors were selected to take TQB3019 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3019 capsules.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose Limiting Toxicity (DLT) — At the end of Cycle 1 (Each cycle is 28 days) DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI Common Terminology Criteria for Adverse Events(CTCAE) version5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from first medication to the end of the first treatment cycle.
Maximum tolerated dose (MTD) — At the end of Cycle 1 (Each cycle is 28 days) MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Recommended Phase II Dose (RP2D) — Baseline up to 24 months DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3019 capsules in adult patients with Advanced Malignant Cancer.
Maximum assessed dose (MAD) — Baseline up to 24 months Recommendations made by the investigator and sponsor based on clinical safety, efficacy, pharmacokinetic, and pharmacodynamic data will be considered the highest dose level to complete dose exploration in the absence of an MTD
Adverse events (AEs) — From the time the subject receives TQB3019 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years) The occurrence of all adverse events (AEs)
Serious adverse events (SAEs) — From the time the subject receives TQB3019 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years) The occurrence of all serious adverse events (SAEs) .
Abnormal incidence of laboratory test indicators — From the time the subject receives TQB3019 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years) Incidence and severity of abnormal laboratory values
Overall response rate (ORR) — From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 3 years The proportion of subjects with best response of Complete Response (CR), Partial Response (PR), Partial Response with Lymphocytosis (PR-L), Very Good Partial Response (VGPR), and Minimal Response (MR).
Trial sites (15)
Facility
City
Region
Status
Cancer Institute & Hospital.Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou
Guangdong
Recruiting
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
Recruiting
Heze Municipal Hospital
Heze
Shandong
Recruiting
The Cancer Hospital Affiliated to Shandong First Medical University
Jinan
Shandong
Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Recruiting
Tongji Hospital of Tongji University
Shanghai
Shanghai Municipality
Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou
Sichuan
Recruiting
Mianyang Central Hospital
Mianyang
Sichuan
Recruiting
Affiliated Hospital of North sichuan Medical college
Nanchong
Sichuan
Recruiting
TianJin Medical University Cancer Institute&Hospital
Tianjin
Tianjin Municipality
Recruiting
Institute of Hematology &Blood Diseases Hospital,Chinese Academy of Medical Sciences &Peking Union Medical College
Tianjin
Tianjin Municipality
Recruiting
More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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