Phase I Clinical Trial Protocol for Tolerability and Pharmacokinetics of TQB3455 Tablets in Patients With Hematological Malignancies

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is a clinical trial to evaluate the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies. TQB3455 is an isocitrate dehydrogenase 2(IDH2) inhibitor . This project is divided into two stages. The first stage aims to evaluate the safety and tolerability of single or multiple oral administration of TQB3455 tablets in subjects with malignant hematological tumors. The second phase aims to evaluate the efficacy and safety of TQB3455 tablets alone or in combination with azacitidine in subjects with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Patients meeting all of the following inclusion criteria can be included in this trial:

• Age ≥ 18 years old;

• According to the World Health Organization (WHO) classification, subjects diagnosed with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) should meet one of the following criteria:

‣ Difficult to treat or recurrent (\>5% of primitive cells reappear in the bone marrow after complete remission) AML; (Single drug group)

⁃ Newly diagnosed AML subjects recognized by researchers as unable to receive standard treatment due to age, physical condition, or risk factors; (Joint group)

• MDS subjects belong to the following prognostic risk categories according to the revised International Prognostic Scoring System (IPSS-R):

‣ Extremely high-risk (\>6 points)

⁃ High risk (\>4.5 points - ≤ 6 points)

⁃ Medium risk (\>3 points - ≤ 4.5 points)

• Clearly indicating the presence of IDH2 gene mutation;

• Blood platelet (PLT) ≥20×10\^9/L; Or subjects with PLT\<20 × 10\^9/L, but recognized by the researchers as being caused by tumor reasons;

• Serum total bilirubin ≤ 1.5 × ULN (for Gilbert syndrome subjects, bilirubin ≤ 3 × ULN);

• Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml/min;

• Recovery of toxic reactions caused by surgery, radiation therapy, or other anti-tumor treatments to ≤ Grade I;

• Women should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Male participants must agree to use contraception during the study period and within 6 months after the end of the study period;

• The subjects voluntarily joined this study.

Locations
Other Locations
China
Peking University international Hospital
NOT_YET_RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Harbin The First Hospital
NOT_YET_RECRUITING
Harbin
Shanghai Sixth People's Hospital
NOT_YET_RECRUITING
Shanghai
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
People's Hospital of Tianjin
NOT_YET_RECRUITING
Tianjin
Contact Information
Primary
Hao Jiang, Master
2516735116@qq.com
13601164350
Backup
Wenbing Duan, Master
yukinoice@yeah.net
Time Frame
Start Date: 2019-10-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
Experimental: TQB3455 tablet and Azacitidine for Injection
Stage1:TQB3455 tablet, oral, once a day, for 28 consecutive days as a treatment cycle.~Stage2:TQB3455 tablet, oral, once a day, for 28 consecutive days as a treatment cycle.~Azacitidine for injection: A treatment cycle of 4 weeks, with subcutaneous injection of Azacitidine standard dose on the first to seventh day of each cycle.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials