Study of YK012 in B-cell Acute Lymphoblastic Leukemia
ConditionB-cell Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorExcyte Biopharma Ltd
About this trial
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.
Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
An estimated survival time of more than 12 weeks.
Ph-negative B-ALL with any of the following: i. Failure to achieve complete remission after initial induction therapy. ii. Failure to achieve complete remission after salvage treatment. iii. Relapse with first remission duration ≤12 months. iv. Second or later relapse. v. Relapse after hematopoietic stem cell transplantation (HSCT).
Disqualifiers
Burkitt´s Leukemia according to World Health Organization (WHO) classification.
Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer
Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 3 weeks
Radiotherapy or chemotherapy (except for intrathecal chemotherapy and dexamethasone), or treatment with Chinese traditional/patent medicine that has definite antitumor effect within 2 weeks
Trial design
Design model
Sequential
Treatments tested in this trial
YK012
DrugThe treatments include 2 cycles of induction treatment, 3 cycles of consolidation treatment, and up to 5 cycles of maintenance treatment.
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: YK012Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The Incidence and Profile of Dose-limiting Toxicity (DLT)
The toxicities occurring within 28 days (i.e., DLT observation period) after the first dose will be defined as DLTs in the discretion of the investigator as related to the IMP (Investigational Medicinal Product). This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study.
Time frame
28 days after the first dose2
Maximum Tolerated dose (MTD) or The Recommended Dose for Future Clinical Study
This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study.
Time frame
Through study completion, 20 weeks3
Number of Participants with Adverse Events
An AE is defined as any untoward medical event that occurs after a subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Time frame
From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.4
Number of Participants with Serious Adverse Events
An SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the subject receives the IMP, and congenital abnormalities or birth defects.
Time frame
From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.Secondary outcomes
1
Area Under the Concentration-time Curve (AUC)
The PK (AUC) of YK012 will be evaluated.
Time frame
Up to 20 weeks2
Maximum Observed Concentration (Cmax)
The PK (Cmax) of YK012 will be evaluated.
Time frame
Up to 20 weeks3
Time to Reach Maximum Concentration (Tmax)
The PK (Tmax) of YK012 will be evaluated.
Time frame
Up to 20 weeks4
Half Life (t1/2) of YK012
The PK (t1/2) of YK012 will be evaluated.
Time frame
Up to 20 weeksSponsors and contacts
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Source ClinicalTrials.gov