[Translation] A Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of oral administration of SDT-102 tablets in patients with relapsed/refractory hematological malignancies
剂量递增阶段(适用于Ia期)
主要目的
评价复发/难治性血液系统恶性肿瘤患者口服SDT-102片的安全性和耐受性;
探索SDT-102片在复发/难治性血液系统恶性肿瘤患者中的剂量限制性毒性(Dose limiting toxicity,DLT)、最大耐受剂量(Maximum tolerable dose,MTD)、II期推荐剂量(Recommended phase 2 dose,RP2D)。
次要目的
评价复发/难治性血液系统恶性肿瘤患者服药后SDT-102的药代动力学(Pharmacokinetics,PK)特征;
评价复发/难治性血液系统恶性肿瘤患者口服SDT-102片的初步有效性(ORR、PFS、DCR,选择ORR为主要观察指标)。
剂量扩展阶段(适用于Ib期)
主要目的
进一步评估验证RP2D剂量下特定的复发/难治性血液系统恶性肿瘤患者口服SDT-102片后的安全性和初步有效性(ORR、PFS、DCR,选择ORR为主要观察指标);
次要目的
进一步评估验证RP2D剂量下复发/难治性血液系统恶性肿瘤患者口服SDT-102片后的PK特征。
[Translation] Dose escalation phase (applicable to Phase Ia)
Main purpose
To evaluate the safety and tolerability of oral SDT-102 tablets in patients with relapsed/refractory hematological malignancies;
To explore the dose limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of SDT-102 tablets in patients with relapsed/refractory hematological malignancies.
Secondary purpose
To evaluate the pharmacokinetic (PK) characteristics of SDT-102 after taking the drug in patients with relapsed/refractory hematological malignancies;
To evaluate the preliminary efficacy of oral SDT-102 tablets in patients with relapsed/refractory hematological malignancies (ORR, PFS, DCR, with ORR as the primary observation index).
Dose expansion phase (applicable to Phase Ib)
Main purpose
Further evaluate and verify the safety and preliminary efficacy (ORR, PFS, DCR, with ORR as the primary outcome measure) of oral administration of SDT-102 tablets in patients with specific relapsed/refractory hematological malignancies at the RP2D dose;
Secondary purpose
Further evaluate and verify the PK characteristics of oral administration of SDT-102 tablets in patients with relapsed/refractory hematological malignancies at the RP2D dose.