Evaluating TQB3454 Tablets for Blood Tumors

A Phase Ib Clinical Trial of TQB3454 Tablets in Patients With Blood Tumors

This study is testing TQB3454 tablets to see if they are safe and effective for people with acute myeloid leukemia and myelodysplastic syndromes.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
• Locations: 17 sites (Bengbu, Anhui and 16 other locations)
• Trial ID: NCT06218771 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and determine the recommended dose of TQB3454 tablets in patients diagnosed with acute myeloid leukemia and myelodysplastic syndromes. It involves both Phase 1 and Phase 2 evaluations to ensure the treatment's efficacy and safety profile. Participants will be monitored for their response to the medication and any potential side effects throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with relapsing or refractory acute myeloid leukemia or myelodysplastic syndromes who have a life expectancy of at least three months.

Not a fit: Patients with acute promyelocytic leukemia or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with blood tumors, potentially improving their outcomes.

How similar studies have performed: While this specific approach is novel, similar studies targeting blood tumors have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

* Patients voluntarily joined the study and signed informed consent with good compliance.
* Men and women; The expected survival is ≥3 months.
* Negative serum/urine pregnancy test within 7 days prior to initial dose and must be non-lactating; Women of childbearing age agree to use contraception (such as an intrauterine device, birth control pill or condom) during the study and for six months after the study completion; Men agreed to use contraception during the study period and for six months after the end of the study.
* The major organs are functioning well;
* For Relapsing/refractory acute myeloid leukemia (AML):

  1. According to the classification criteria for Hematopoietic and lymphoid tissue tumors revised by the World Health Organization (WHO) in 2016, AML confirmed by bone marrow cell morphology, excluding acute promyelocytic leukemia (APL).
  2. ≥18 years old; Eastern Cooperative Oncology Group (ECOG) score is 0\~2.
  3. Blood biochemical examination:

  i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases; ii: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT and AST≤5×ULN if liver infiltration was associated.
* For myelodysplastic syndrome (MDS) with higher risk:

  1. MDS patients were confirmed by bone marrow cell morphology and cytogenetics and met the classification criteria of hematopoietic and lymphoid tissue tumors revised by WHO in 2016.
  2. ≥18 years old; ECOG score is 0\~2. c. Blood biochemical examination:

  i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases.

ii: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT and AST≤5×ULN if concomitant with liver infiltration.

Exclusion Criteria:

* Tumor diseases and history:

  1. The tumor has or is suspected to involve the central nervous system, or primary Central nervous system leukemia.
  2. Present or present with other malignant tumors within 3 years prior to the first dose. Except the following conditions: for other malignancies treated with a single operation, achieving a 5-year continuous disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)\].
  3. Severe life-threatening complications of leukemia, such as uncontrolled bleeding, hypoxia or shock pneumonia, and disseminated intravascular coagulation.
* Previous antitumor therapy:

  1. Received National Medical Products Administration (NMPA) approved Chinese patent drugs with anticancer indications specified in the drug label within 2 weeks prior to initial administration.
  2. Toxicities associated with previous antineoplastic therapy did not return to CTCAE≤1, except for hair loss, fatigue and poor appetite.

     3. Associated diseases and history:

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  1. Abnormal liver.
  2. Renal abnormalities.
  3. Gastrointestinal abnormalities.
  4. Cardio-cerebrovascular abnormalities.
  5. Immune-related history.
  6. Lung disease.
  7. Comorbidities that were severe or poorly controlled and, in the investigator's judgment, significantly compromised patient safety or hindered study completion.
  8. Risk of bleeding.
* History of drug abuse or drug abuse.
* Participated in clinical trials of other drugs within the past 30 days;
* It is estimated that the patient's compliance to participate in this clinical study is insufficient.

Where this trial is running

Bengbu, Anhui and 16 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (RECRUITING)
• Cangzhou people's Hospital — Cangzhou, Hebei, China (RECRUITING)
• The Affiliated Hospital of Chengde Medical College — Chengde, Hebei, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• Union Hospital Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)
• Wuxi People's Hospital — Wuxi, Jiangsu, China (RECRUITING)
• Affiliated Hospital of Binzhou Medical College — Binzhou, Shandong, China (RECRUITING)
• Yantai Mountain Hospital — Yantai, Shandong, China (RECRUITING)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (RECRUITING)
• Shanghai Tongren Hospital — Shanghai, Shanghai, China (RECRUITING)
• Huashan Hospital affiliated to Fudan University — Shanghai, Shanghai, China (RECRUITING)
• Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (RECRUITING)
• Shanghai Sixth People's Hospital — Shanghai, Shanghai, China (RECRUITING)
• Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai, China (RECRUITING)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)
• Hospital of Hematology, Chinese Academy of Medical Sciences — Tianjin, Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Yu Hu, Doctor

Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes