A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors

NCT04975204 | Unknown Phase 1

• 1 other identifier: TQB3909-I-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief Summary

TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the release of cytochrome c from mitochondria, phosphatidylserine eversion, stimulates caspase 3 / 7 activity and caspase 3 / 9 cleavage, and induces apoptosis.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity（DLT）

  DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

  up to 18 months

• Recommended Phase II Dose (RP2D)

  DLT describes side effects of a drug or other treatment that are serious enough to To evaluate RP2D of TQB3909 tablets in adult patients with advanced solid tumors

  up to 18 months

Secondary Outcomes (21)

• Adverse events (AEs) and serious adverse events (SAEs)

  up to 18 months

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

  Within 32 weeks after administration

• Maximum (peak) plasma drug concentration (Cmax)

  Within 24 hours after administration

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

  Within 32 weeks after administration

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

  Within 24 hours after administration

Study Arms (1)

TQB3909 Tablets

EXPERIMENTAL

Take 100-1200mg once a day; Oral administration on an empty stomach, 28 days as a cycle.

Drug: TQB3909 Tablets

Interventions

TQB3909 Tablets DRUG

TQB3909 is an inhibitor targeting BCL-2 protein

TQB3909 Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects volunteered to join the study and signed informed consent form (ICF)with good compliance.
• Age: ≥ 18 years old (when signing ICF); Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; The expected survival period is more than 3 months.
• Advanced malignant tumor diagnosed by histology or cytology.
• Relapse or failure after previous standard treatment, or intolerance to standard treatment, and no other better treatment options.
• Subject population:a)Dose escalation stage: non-Hodgkin's lymphoma;b) Dose expansion stage: non-Hodgkin's lymphoma, plasmacytoma, acute myeloid leukemia, myelodysplastic syndrome, etc.
• At least 1 lesion / measurable disease for efficacy evaluation.
• The function of main organs are well, and the following examination results are good: routine blood examination, biochemical examination, blood coagulation function examination, and heart color Doppler ultrasound evaluation.
• Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; The serum pregnancy test iss negative within 7 days before the enrollment and must be non-lactating subjects; Male subjects should agree to avoid childbirth during the study period and within 6 months after the end of the study period.

You may not qualify if:

• Combined disease and History:
• There were other malignant tumors in 3 years before the first medication. The following two cases can be included: other malignant tumors treated by single operation have achieved 5-year disease-free survival (DFS) in a row; The cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non-invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• The diagnosis was Burkitt lymphoma, lymphoblastic lymphoma / leukemia, etc;
• Central nervous system (CNS) invasion was found;
• He has received allogeneic hematopoietic stem cell transplantation in the past;
• Autologous hematopoietic stem cell transplantation was performed 3 months before the first administration;
• There are many factors influencing oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• Unrelieved toxicity of ≥ circulating tumor cells(CTC) AE 1 due to any previous treatment, excluding alopecia;
• Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study;
• There are active or uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA), idiopathic thrombocytopenic purpura (ITP), etc;
• Arteriovenous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
• Have a history of psychotropic drug abuse and can not quit or have mental disorders;
• Subjects with any severe and / or uncontrolled disease included:
• Patients with ≥ 2 grade myocardial ischemia 6 months between the first administration or myocardial infarction, arrhythmia (male corrected QT interval (QTc) \> 450ms, female QTc \> 470ms) and ≥ 2 grade congestive heart failure (NYHA classification), Cardiac color Doppler ultrasound to evaluate left ventricular ejection fraction（LVEF）\<50%;
• There was active severe infection (≥ CTC AE grade 2 infection);

Sponsors & Collaborators

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

Study Sites (2)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences &Peking Union Medical College

Tianjin, Tianjin Municipality, 300041, China

RECRUITING

Central Study Contacts

Jianyong Li, Doctor

CONTACT

13951877733; lijianyonglm@126.com

Wei Xu, Doctor

CONTACT

13951699449; xuwei0484@jsph.org.cn

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: July 14, 2021
• First Posted: July 23, 2021
• Study Start: February 18, 2022
• Primary Completion: December 1, 2022
• Study Completion: August 1, 2024
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)