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

Sponsor

Sunshine Lake Pharma Co., Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04865458

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Refractory B-cell Hematologic Malignancies	Drug: HEC89736	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing	Beijing	China
2	Jiangsu Province Hospital	Nanjing	Jiangsu	China

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunshine Lake Pharma Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04865458

Other Study ID Numbers:

HEC89736-P-01

First Posted:

Apr 29, 2021

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Study Results

No Results Posted as of May 6, 2022