This Study is a FIH Study Which is Required to Understand the PK Characteristics, MTD, RP2D and S… (NCT06756451) | Clinical Trial Compass
RecruitingPhase 1
This Study is a FIH Study Which is Required to Understand the PK Characteristics, MTD, RP2D and Safety Profile.
China71 participantsStarted 2025-03-25
Plain-language summary
This study is a first-in-human (FIH) study which is required to understand the safety, tolerability, pharmacokinetics and preliminary efficacy of RJK-RT2831 injection in patients with hematologic malignancies
Who can participate
Age range18 Years – 74 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓5. Phase Ib tentatively includes patients with hematologic malignancies that meet the following criteria: relapsed or refractory AML subjects who have received at least one previous treatment and have failed to current standard treatments that provide clinical benefit, and MDS subjects who are diagnosed according to the 5th edition of the WHO Classification of Haematolymphoid Tumours-Myeloid and Histiocytic/Dendritic Neoplasms (Khoury et al., 2022) and are classified as high-risk or very-high-risk according to the Revised International Prognostic Scoring System (IPSS-R) (Greenberg et al., 2012). The specific tumor type will be determined based on the results of the Phase Ia trial and may be extended to other hematologic malignancies.
✓. Bone marrow function: white blood cell count ≤ 30×10\^9/L;
✓. Liver function: TBIL ≤ 1.5×ULN, TBIL ≤ 3×ULN if Gilbert's syndrome; ALT and AST ≤ 3 ×ULN;
✓. Renal function: creatinine clearance rate (CCr) \> 50 mL/min calculated according to the Cockcroft-Gault method
✓. Coagulation function: activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5×ULN.
Exclusion criteria
✕. Received cytotoxic chemotherapy (except hydroxyurea use for subjects with leukocytosis \>10,000 cells/mm3 or rapid disease progression), radiotherapy (except local palliative radiotherapy), immunotherapy, targeted therapy and other anti-tumor treatments within 14 days;
✕. Received adoptive cell therapy, such as autologous or donor natural killer cell or T lymphocyte infusions (e.g., chimeric antigen receptor-T cells), unless \> 60 days prior to the first dose of study treatment and treatment-related toxicities have resolved to at least Grade 1;
What they're measuring
1
phase Ia and phase Ib: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Timeframe: The summary of all AEs was dominated by adverse events that occurred during treatment, including any AE that occurred from the first administration of the study drug until 28 ± 7 days after the last administration.
2
phase Ia: Maximum Tolerated Dose (MTD)
Timeframe: From the first administration of the study drug until 28 days after the first dose
3
phase Ia: Recommended Doses for Expansion (RDEs)
Timeframe: From the first administration of the study drug until 28 ±7 days after the last administration and prior to the initiation of a new anti-tumor therapy
4
phase Ib: Recommended Phase II Dose (RP2D)
Timeframe: From the first administration of the study drug until 28 ±7 days after the last administration and prior to the initiation of a new anti-tumor therapy
. Received any investigational drug (for any indication) within 5 half-lives of the drug or 14 days, whichever is longer;
✕. Received an autologous haematopoietic stem cell transplant within 12 weeks.
✕. Resting state, mean QTcF \> 480 ms in men/women derived from 12-lead electrocardiogram (ECG) (repeated 3 times); Note: QTcF = QTcB ×RR\^0.17, QTcB is the corrected QT interval obtained using the Bazetts correction formula;
✕. Echocardiogram or multigated acquisition (MUGA) scan showing a left ventricular ejection fraction of less than 50%;
✕. Symptomatic or treatment-requiring abnormalities in rhythm, conduction, and resting ECG morphology, such as arrhythmias, degree II or III atrioventricular block, congestive heart failure (New York Heart Association cardiac function class III or IV)
✕. New onset of angina pectoris and myocardial infarction within 6 months prior to initiation of study treatment;