NCT04865458

TerminatedPhase 1

A Study to Evaluate the Tolerability, Safety, Pharmacokineti...

Sunshine Lake Pharma Co., Ltd.Source

Sunshine Lake Pharma Co., Ltd.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

HEC89736-P-01

Study Type

interventional

Actual enrollment (reported)

5

Locations

1 country

Sites

2

Timeline

Study Start

April 1, 2021

Actual (reported)

Primary Completion

September 21, 2022

Actual (reported)

Study Completion

September 21, 2022

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 5 participants
Study completion date: September 21, 2022
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 1, 2021
Actual (reported)
First Submitted
April 26, 2021
Actual (reported)
First Posted
April 29, 2021
Actual (reported)
Primary Completion
September 21, 2022
Actual (reported)
Study Completion
September 21, 2022
Actual (reported)

Last Updated: May 14, 2026
Status Verified: May 2026
Last Update Submitted: May 11, 2026

Conditions

Relapsed or Refractory B-cell Hematologic Malignancies

Outcome Measures

Primary Outcomes (2)

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

Study Arms (1)

HEC89736 treatment

EXPERIMENTAL

HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle

Drug: HEC89736

Interventions

HEC89736Drug

HEC89736 tablets QD every 28 days for each cycle

HEC89736 treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age is over 18 years old
Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies

Sponsors & Collaborators

Sunshine Lake Pharma Co., Ltd.
Industrylead

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Li Jianyong, Doctor
The First Affiliated Hospital with Nanjing Medical University
PRINCIPAL INVESTIGATOR
Song Yuqing, Doctor
Peking University Cancer Hospital & Institute
PRINCIPAL INVESTIGATOR

Enrollment

5 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 29, 2021

Study Start

April 1, 2021

Actual (reported)

Primary Completion

ECOG performance status (PS) 0 \~ 1

Expected survival of \> or = 3 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

September 21, 2022

Actual (reported)

Study Completion

September 21, 2022

Actual (reported)

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04865458
Data provider: ClinicalTrials.gov
Source updated: 2026-05-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:43 UTC

Locations

CN(2)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

HEC89736 treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

HEC89736 treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations