Evaluating TQB3455 Tablets for Patients with Blood Cancers

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

This study is testing a new tablet called TQB3455 to see if it is safe and effective for people with blood cancers like acute myeloid leukemia and myelodysplastic syndrome.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 7 sites (Beijing, Beijing Municipality and 6 other locations)
• Trial ID: NCT06550713 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies, specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The trial is divided into two stages: the first assesses the safety of single or multiple doses of TQB3455, while the second examines its efficacy and safety when used alone or in combination with azacitidine. Participants will be closely monitored for their response to the treatment and any side effects experienced.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with AML or MDS who have specific IDH2 gene mutations and meet certain risk criteria.

Not a fit: Patients without the IDH2 gene mutation or those with lower-risk classifications for AML or MDS may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat blood cancers.

How similar studies have performed: Other studies involving IDH2 inhibitors have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

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:

  1. Difficult to treat or recurrent (\>5% of primitive cells reappear in the bone marrow after complete remission) AML; (Single drug group)
  2. 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):

  1. Extremely high-risk (\>6 points)
  2. High risk (\>4.5 points - ≤ 6 points)
  3. 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.

Exclusion Criteria:

* Subjects who experience relapse after bone marrow transplantation;
* Subjects who have received systemic anti-tumor therapy or radiation therapy within 3 weeks prior to the use of the investigational drug;
* Individuals who have participated in clinical trials of other drugs within the four weeks prior to using the investigational drug;
* Individuals with multiple factors that affect oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction;
* Subjects who have previously used targeted isocitrate dehydrogenase 2 (IDH2) inhibitors;
* The subject has uncontrolled systemic fungal, bacterial, or viral infections;
* High blood pressure subjects who are still poorly controlled despite drug treatment;
* Obvious cardiovascular diseases, such as heart failure classified as grade 2 or above by the New York Heart Association (NYHA), unstable angina in the past 3 months, myocardial ischemia or infarction, arrhythmia and grade I heart failure, or the presence of other factors at risk of prolonging the QT interval (such as arrhythmia, hypokalemia ≥ grade 3, family history of long QT interval);
* Severe leukemia complications that endanger life, such as uncontrolled bleeding, hypoxia or shock pneumonia, disseminated intravascular coagulation;
* Subjects known to have central nervous system leukemia or clinical symptoms of central nervous system leukemia;
* Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
* Subjects with active replication of hepatitis B virus and hepatitis C virus;
* Individuals with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
* According to the researcher's judgment, there are accompanying diseases that pose a serious threat to the safety of the subjects or affect their ability to complete the study.

Where this trial is running

Beijing, Beijing Municipality and 6 other locations

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University international Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Harbin The First Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• People's Hospital of Tianjin — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Hao Jiang, Master

Conditions Acute Myeloid Leukemia; Myelodysplastic Syndrome