[Translation] A multicenter, open-label, phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor efficacy of YK012 in the treatment of B-cell acute lymphoblastic leukemia

Ib期剂量递增研究：（1）主要目的：评价YK012在B细胞急性淋巴细胞白血病患者中的安全性和耐受性。（2）次要目的：评价YK012在B细胞急性淋巴细胞白血病患者中的药代动力学(PK)特征；评价YK012在B细胞急性淋巴细胞白血病患者中的免疫原性；初步探索YK012在B细胞急性淋巴细胞白血病中的血液学缓解(完全缓解/完全缓解伴部分血液学恢复[CR/CRi])率。（3）探索性目的：探索YK012的药效动力学(PD)特征。 Ⅱ期剂量扩展研究：（1）主要目的：进一步评价YK012在选定剂量下治疗B细胞急性淋巴细胞白血病成人患者中的安全性、耐受性和初步抗肿瘤疗效。（2）次要目的：进一步评价YK012在选定剂量下治疗B细胞急性淋巴细胞白血病患者中的PK特征；进一步评价YK012在B细胞急性淋巴细胞白血病患者中的免疫原性。（3）探索性目的：探索YK012的PD特征。

[Translation]

Phase Ib dose escalation study: (1) Primary objective: To evaluate the safety and tolerability of YK012 in patients with B-cell acute lymphoblastic leukemia. (2) Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of YK012 in patients with B-cell acute lymphoblastic leukemia; To evaluate the immunogenicity of YK012 in patients with B-cell acute lymphoblastic leukemia; To preliminarily explore the hematological remission (complete remission/complete remission with partial hematological recovery [CR/CRi]) rate of YK012 in B-cell acute lymphoblastic leukemia. (3) Exploratory objective: To explore the pharmacodynamic (PD) characteristics of YK012. Phase II dose expansion study: (1) Primary objective: To further evaluate the safety, tolerability and preliminary anti-tumor efficacy of YK012 in the treatment of adult patients with B-cell acute lymphoblastic leukemia at selected doses. (2) Secondary objectives: To further evaluate the PK characteristics of YK012 in patients with B-cell acute lymphoblastic leukemia at selected doses; To further evaluate the immunogenicity of YK012 in patients with B-cell acute lymphoblastic leukemia. (3) Exploratory objectives: To explore the PD characteristics of YK012.

Start Date25 Sep 2024

Sponsor / Collaborator

Excyte Biopharma Ltd

NCT06580301 / RecruitingPhase 1/2

An Open-Label, Multi-Center, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YK012 in Participants with B-cell Acute Lymphoblastic Leukemia

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).

Start Date25 Sep 2024

Sponsor / Collaborator

Excyte Biopharma Ltd

CTR20230158 / RecruitingPhase 1

评价YK012治疗复发性/难治性B细胞非霍奇金淋巴瘤患者的安全性、耐受性、药代动力学特征和初步抗肿瘤疗效的多中心、开放性、I期临床研究

[Translation] A multicenter, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor efficacy of YK012 in the treatment of patients with relapsed/refractory B-cell non-Hodgkin's lymphoma

主要目的：Ia期：评价YK012在复发性/难治性B细胞非霍奇金淋巴瘤患者中的安全性和耐受性；探索YK012在复发性/难治性B细胞非霍奇金淋巴瘤患者中的剂量限制性毒性（DLT）、最大耐受剂量（MTD）、和/或后续临床研究的推荐剂量。Ib期：进一步评价YK012在选定剂量下治疗复发性/难治性B细胞非霍奇金淋巴瘤患者中的安全性和初步抗肿瘤疗效。次要目的：Ia期：评价YK012在复发性/难治性B细胞非霍奇金淋巴瘤患者中的药代动力学（PK）特征；评价YK012在复发性/难治性B细胞非霍奇金淋巴瘤患者中的免疫原性；初步探索YK012在复发性/难治性B细胞非霍奇金淋巴瘤患者中的抗肿瘤疗效。Ib期：进一步探索YK012在选定剂量下治疗复发性/难治性B细胞非霍奇金淋巴瘤患者中的抗肿瘤疗效；进一步评价YK012在选定剂量下治疗复发性/难治性B细胞非霍奇金淋巴瘤患者中的PK特征；进一步评价YK012在选定剂量下治疗复发性/难治性B细胞非霍奇金淋巴瘤患者中的免疫原性；进一步评价YK012在选定剂量下治疗复发性/难治性B细胞非霍奇金淋巴瘤患者中的安全性。探索性目的：探索YK012的药效动力学（PD）特征。

[Translation]

Primary objectives: Phase Ia: Evaluate the safety and tolerability of YK012 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma; explore the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended dose for subsequent clinical studies of YK012 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. Phase Ib: Further evaluate the safety and preliminary anti-tumor efficacy of YK012 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma at selected doses. Secondary objectives: Phase Ia: Evaluate the pharmacokinetic (PK) characteristics of YK012 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma; evaluate the immunogenicity of YK012 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma; and preliminarily explore the anti-tumor efficacy of YK012 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. Phase Ib: Further explore the anti-tumor efficacy of YK012 at selected doses in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma; further evaluate the PK characteristics of YK012 at selected doses in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma; further evaluate the immunogenicity of YK012 at selected doses in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma; further evaluate the safety of YK012 at selected doses in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. Exploratory purpose: Explore the pharmacodynamic (PD) characteristics of YK012.

Start Date09 May 2023

Sponsor / Collaborator

Excyte Biopharma Ltd

100 Clinical Results associated with YK012

100 Translational Medicine associated with YK012

100 Patents (Medical) associated with YK012

100 Deals associated with YK012

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CD19-positive B-cell acute lymphoblastic leukemia	Phase 2	CN	Excyte Biopharma Ltd	25 Sep 2024
B-cell lymphoma recurrent	Phase 1	CN	Excyte Biopharma Ltd	09 May 2023
B-cell lymphoma refractory	Phase 1	CN	Excyte Biopharma Ltd	09 May 2023
Glomerulonephritis, Membranous	Preclinical	CN	Excyte Biopharma Ltd	01 Oct 2024
Systemic Lupus Erythematosus	Preclinical	CN	Excyte Biopharma Ltd	01 Oct 2024

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