NCT06082596

Study of BEBT-908 in Subjects With Advanced Hematological Tumors

A Multicenter, Open, Phase I Clinical Study of BEBT-908 for Injection in the Treatment of Relapsed Refractory Malignant Lymphoma, Multiple Myeloma and Chronic Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: BeBetter Med Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and tolerance of BEBT-908 for injection in the treatment of recurrent refractory malignant lymphoma, multiple myeloma and chronic lymphoblastic leukemia, and to obtain the pharmacokinetic data and preliminary efficacy of BEBT-908 for injection, and to explore the relationship between the safety and efficacy of BEBT-908 for injection and related biomarkers.

Detailed description

This study is divided into two stages: dose increasing stage and expanding into the group. Dose escalation phase: The initial dose was 10mg/m2, and the subsequent dose group was increased by 100% until the first case of grade 2 non-blood toxicity or grade 3 hematological toxicity related to the test drug and no dose-limiting toxicity, then the dose was increased by 50%, and a total of 5 dose groups were designed. In this stage, all subjects received a single dose first and were observed for 6 days. After the end of the observation period, if the subjects were safely tolerant to a single dose，then will receive the same dose of treatment for a cycle, administration regimen is 3 times a week, continuous administration for 2 weeks, withdrawal for 1 week, a total of 21 days as a cycle. Dose expansion phase: according to the results of pharmacokinetics, safety and efficacy of BEBT-908 for injection obtained in the dose escalation phase, we plan to select two doses to further observe the safety, pharmacokinetic characteristics and preliminary efficacy of BEBT-908 for injection in about 20-40 subjects with non-Hodgkin's malignant lymphoma. In this stage, all dose groups were administered continuously for 2 weeks and stopped for 1 week for a total of 21 days，until the disease progresses or withdraws. Participants will need to understand the requirements and risks of the trial, sign an informed consent form, accept the dosing regimen required by the trial protocol, and follow the investigator's guidance.

Conditions

• Relapsed or Refractory Non-Hodgkin's Lymphoma
• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	BEBT-908 for injection	Dose escalation phase：10 or 15、22.5、33.75、45mg/m2, intravenous drip, firstly single dose, after the observation period, the drug was administered continuously for 1 cycle (21 days), 3 times a week, continuous administration for 2 weeks and withdrawal for 1 week. Dose expansion phase：15 or 22.5mg/m2，intravenous drip, 3 times a week, continuous administration for 2 weeks and withdrawal for 1 week，21 days as cycle.

Timeline

• Start date: 2016-03-02
• Primary completion: 2019-03-08
• Completion: 2019-03-08
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: China