Study of BEBT-908 in Subjects With Advanced Hematological Tumors

NCT06082596 | Completed Phase 1

• 1 other identifier: GBMT-908-P01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

BEBT-908 for injection; Safety; Tolerability; Pharmacokinetics; Effectiveness

Outcome Measures

Primary Outcomes (2)

• DLT

  Dose-limiting toxicity

  Dose escalation phase: a 6-day observation after a single administration, cycle 1st of continuous medication (21 days). Dose expansion phase: from date of administration until the date of disease progression or withdrawal, assessed up to 36 months.

• MTD

  Maximum tolerated dose

  Dose escalation phase: a 6-day observation after a single administration, cycle 1st of continuous medication (21 days). Dose expansion phase: from date of administration until the date of disease progression or withdrawal, assessed up to 36 months.

Secondary Outcomes (11)

• AE

  From the first administration of the study drug to 30 days after the last administration of the study drug.

• Cmax

  Day 1 and Day 12 of cycle 1 before and within 24 hours after administration (each cycle is 21 days).

• Tmax

  Day 1 and Day 12 of cycle 1 before and within 24 hours after administration (each cycle is 21 days).

• t1/2

  Day 1 and Day 12 of cycle 1 before and within 24 hours after administration (each cycle is 21 days).

• AUC0-24h

  Day 1 and Day 12 of cycle 1 before and within 24 hours after administration (each cycle is 21 days).

Study Arms (7)

Monotherapy group 1(Dose escalation phase)

EXPERIMENTAL

BEBT-908 for injection， dosage form ：Injection； specification: 25 mg , administration method: 10mg/m2，intravenous drip, firstly the subjects were given a single dose and observed for 6 days. At the end of the observation period, if the subjects were tolerant to a single dose and safe, they would receive the same dose for a cycle (21 days), giving the drug three times a week for 2 weeks and stopping the drug for 1 week. A total of 21 days is a cycle.

Drug: BEBT-908 for injection

Monotherapy group 2(Dose escalation phase)

EXPERIMENTAL

BEBT-908 for injection， dosage form ：Injection； specification: 25 mg , administration method: 15mg/m2，intravenous drip, firstly the subjects were given a single dose and observed for 6 days. At the end of the observation period, if the subjects were tolerant to a single dose and safe, they would receive the same dose for a cycle (21 days), giving the drug three times a week for 2 weeks and stopping the drug for 1 week. A total of 21 days is a cycle.

Drug: BEBT-908 for injection

Monotherapy group 3(Dose escalation phase)

EXPERIMENTAL

BEBT-908 for injection， dosage form ：Injection； specification: 25 mg , administration method: 22.5mg/m2，intravenous drip, firstly the subjects were given a single dose and observed for 6 days. At the end of the observation period, if the subjects were tolerant to a single dose and safe, they would receive the same dose for a cycle (21 days), giving the drug three times a week for 2 weeks and stopping the drug for 1 week. A total of 21 days is a cycle.

Drug: BEBT-908 for injection

Monotherapy group 4(Dose escalation phase)

EXPERIMENTAL

BEBT-908 for injection， dosage form ：Injection； specification: 25 mg , administration method: 33.75mg/m2，intravenous drip, firstly the subjects were given a single dose and observed for 6 days. At the end of the observation period, if the subjects were tolerant to a single dose and safe, they would receive the same dose for a cycle (21 days), giving the drug three times a week for 2 weeks and stopping the drug for 1 week. A total of 21 days is a cycle.

Drug: BEBT-908 for injection

Monotherapy group 5(Dose escalation phase)

EXPERIMENTAL

BEBT-908 for injection， dosage form ：Injection； specification: 25 mg , administration method: 45mg/m2，intravenous drip, firstly the subjects were given a single dose and observed for 6 days. At the end of the observation period, if the subjects were tolerant to a single dose and safe, they would receive the same dose for a cycle (21 days), giving the drug three times a week for 2 weeks and stopping the drug for 1 week. A total of 21 days is a cycle.

Drug: BEBT-908 for injection

Monotherapy group 6（Dose expansion phase）

EXPERIMENTAL

BEBT-908 for injection ，dosage form ：Injection ；specification: 25mg , administration method: 15mg/m2，intravenous drip, 3 times a week, continuous administration for 2 weeks and withdrawal for 1 week，21 days as cycle, until the disease progressed or withdrew.

Drug: BEBT-908 for injection

Monotherapy group 7（Dose expansion phase）

EXPERIMENTAL

BEBT-908 for injection ，dosage form ：Injection ；specification: 25mg , administration method: 22.5mg/m2，intravenous drip, 3 times a week, continuous administration for 2 weeks and withdrawal for 1 week，21 days as cycle, until the disease progressed or withdrew.

Drug: BEBT-908 for injection

Interventions

BEBT-908 for injection DRUG

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.

Also known as: CUDC-908

Monotherapy group 1(Dose escalation phase); Monotherapy group 2(Dose escalation phase); Monotherapy group 3(Dose escalation phase); Monotherapy group 4(Dose escalation phase); Monotherapy group 5(Dose escalation phase); Monotherapy group 6（Dose expansion phase）; Monotherapy group 7（Dose expansion phase）

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dose escalation phase:
• Age ≥ 18 and ≤ 70 years old, both men and women.
• Tissue biopsy, bone marrow examination and / or hematological examination confirmed relapsed refractory （Note 1） malignant lymphoma, chronic lymphoblastic leukemia and multiple myeloma. （Note 2 and Note 3）
• With measurable lesions . (Note 4)
• Eastern Cooperative Oncology Group (ECOG) score≤2.
• The level of organ function must meet the following requirements:
• Bone marrow:
• Absolute neutrophil count (ANC) ≥ 1000 /μL (if recent bone marrow biopsies or smears prove tumor progression, this index can be \< 1000/μL).
• Hemoglobin (HGB) ≥ 9g/dL.
• Platelet count (PLT) ≥ 1000000/μL (if recent bone marrow biopsies or smears prove tumor progression, this index can be \< 1000000/μL).
• Liver function:
• In patients with serum bilirubin ≤ 1.5 ×upper limit of normal value (ULN) or Gilbert syndrome, the total bilirubin is less than 3.0 × ULN and direct bilirubin is within the normal range.
• Serum creatinine \< 1.5×ULN; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST)or Alkaline phosphatase (ALP) ≤ 2.5 ×ULN.
• When there is liver metastasis, ALT, AST or ALP ≤ 5 × ULN.
• Non-pregnant women and male and female subjects who did not consider fertility during and after the trial, or who had preserved sperm or eggs in vitro before the trial, or reconsidered fertility according to reproductive function 5 years after the end of the trial.

You may not qualify if:

• Dose escalation phase:
• Severe allergies to research drugs or any of their excipients are known.
• Because the research drugs may have genotoxicity, mutagenicity and teratogenicity, the following subjects should be excluded: men and women who plan to reproduce within 5 years without in vitro preservation of sperm or eggs before the trial, unless follow-up studies confirm reproductive safety; pregnant or lactating women.
• The treatment of the subjects before the trial:
• Bone marrow transplantation was performed within 3 months before enrolling the group.
• Received bone marrow inhibitory chemotherapy or biotherapy within 3 weeks before enrolling the group.
• Within 3 months before enrolling the group, subjects received radiotherapy that affected the efficacy evaluation of this study, or local supportive radiotherapy that affected the bone marrow function of the subjects.
• Subjects received any hematopoietic colony stimulating factor therapy (such as granulocyte colony stimulating factor （G-CSF）, granulocyte macrophage colony stimulating factor（GM-CSF）) within 2 weeks before enrolling the group (Note 1).
• Major surgery was performed within 14 days before enrolling the group, or the side effects of the operation were not stable.
• Subjects received glucocorticoid prednisone daily \>10mg (or equivalent drug) treatment within 7 days before enrollment. (Note 2)
• After the previous treatment (chemotherapy or biotherapy), there was persistent toxicity of grade 2 or above, which was not stable at the time of admission (except hair loss).
• The organ systems of the subjects were as follows:
• Diabetes mellitus with poorly controlled blood sugar.
• Severe lung disease (Common Terminology Criteria for Adverse Events Version 4.03（CTCAE V4.03）, III-IV).
• Active heart disease (Note 3) (New York Heart Association grade III and IV).

Sponsors & Collaborators

• BeBetter Med Inc: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, Non-Hodgkin; Multiple Myeloma

Interventions

BEBT-908; Injections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hui Zhou, Phd

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: March 2, 2016
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

CN (1)