A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies

A Phase I Single Arm,Open-label,Multiple Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies

Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory B-cell Hematologic Malignancies
• Intervention / Treatment: Drug: HEC89736

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age is over 18 years old
• Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies
• ECOG performance status (PS) 0 ~ 1
• Expected survival of > or = 3 months

Exclusion Criteria:

• The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group)
• Received any other anti-cancer treatment within 4 weeks
• Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption
• Allergy, or known to have a history of allergy to the drug components

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEC89736 treatment; HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle	Drug: HEC89736; HEC89736 tablets QD every 28 days for each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose	Incidence of dose limited toxicities and associated dose of HEC89736	Dosing started until the 28th day
Adverse events evaluated by NCI CTCAE 5.0	Incidence of adverse events and associated dose of HEC89736	From the frst dose to within 30 days after the last dose

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.
• Investigators: Principal Investigator: Li Jianyong, Doctor, The First Affiliated Hospital with Nanjing Medical University; Principal Investigator: Song Yuqing, Doctor, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: HEC89736-P-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No