A Study of TQB3454 Tablets in Patients With Blood Tumors

NCT06218771 | Unknown Phase 1

• 1 other identifier: TQB3454-Ib-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this clinical trial is to evaluate the safety of TQB3454 tablets in patients with acute myeloid leukemia and myelodysplastic syndrome, and determine the phase II recommended dose.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (3)

• The rate of all adverse events (AEs), serious adverse events (SAEs)

  Proportion of patients with adverse events/serious adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE5.0)

  Up to 80 weeks

• The severity of all adverse events (AEs), serious adverse events (SAEs)

  The severity of adverse events/serious adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE5.0)

  Up to 80 weeks

• Incidence of abnormal laboratory values

  The proportion of patients with abnormal laboratory examination indicators mainly included blood routine, blood routine, blood biochemistry, coagulation function, thyroid function, myocardial enzyme profile, urine routine, stool routine and 12-lead electrocardiogram.

  Up to 80 weeks

Secondary Outcomes (20)

• Peak time (Tmax)

  Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.

• Peak concentration (Cmax)

  Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.

• Area under blood concentration-time curve (AUC 0-24h)

  Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.

• Steady-state apparent volume of distribution (Vz/F)

  Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.

• Steady-state blood trough concentration (Cmin,ss)

  Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.

Study Arms (1)

TQB3454 Tablets

EXPERIMENTAL

TQB3454 Tablets, orally administered, 28 days as a treatment cycle.

Drug: TQB3454 Tablets

Interventions

TQB3454 Tablets DRUG

TQB3454 Tablets is a selective isocitrate dehydrogenase 1 (IDH1) mutation inhibitor

TQB3454 Tablets

Eligibility Criteria

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

You may qualify if:

• 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):
• 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).
• ≥18 years old; Eastern Cooperative Oncology Group (ECOG) score is 0\~2.
• 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:
• 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.
• ≥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.

You may not qualify if:

• Tumor diseases and history:
• The tumor has or is suspected to involve the central nervous system, or primary Central nervous system leukemia.
• 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)\].
• Severe life-threatening complications of leukemia, such as uncontrolled bleeding, hypoxia or shock pneumonia, and disseminated intravascular coagulation.
• Previous antitumor therapy:
• 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.
• Toxicities associated with previous antineoplastic therapy did not return to CTCAE≤1, except for hair loss, fatigue and poor appetite.
• \. Associated diseases and history:
• <!-- -->
• Abnormal liver.
• Renal abnormalities.
• Gastrointestinal abnormalities.
• Cardio-cerebrovascular abnormalities.
• Immune-related history.
• Lung disease.

Sponsors & Collaborators

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

Study Sites (17)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233000, China

RECRUITING

Cangzhou people's Hospital

Cangzhou, Hebei, 061000, China

RECRUITING

The Affiliated Hospital of Chengde Medical College

Chengde, Hebei, 067000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

RECRUITING

Affiliated Hospital of Binzhou Medical College

Binzhou, Shandong, 264008, China

RECRUITING

Yantai Mountain Hospital

Yantai, Shandong, 264008, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, 264008, China

RECRUITING

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200437, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Hospital of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Central Study Contacts

Yu Hu, Doctor

CONTACT

027-85726685; dr.huyu@126.com

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: January 12, 2024
• First Posted: January 23, 2024
• Study Start: July 10, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

CN (17)