Relapsed or Refractory B-cell Hematologic MalignanciesPhase 1NCT04865458
A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
A Phase 1 study testing HEC89736 in people with Relapsed or Refractory B-cell Hematologic Malignancies, run by Sunshine Lake Pharma Co., Ltd. at 2 sites in China.
Trial summary
Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B-cell Hematologic Malignancies
- What is being tested?
- HEC89736
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2021to 21 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jiangsu Province Hospital
Nanjing, Jiangsu
About this study
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
Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies
- Being tested
- HEC89736
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC89736Drug
HEC89736 tablets QD every 28 days for each cycle
| Study group | Role | What they receive |
|---|---|---|
| HEC89736 treatment | Experimental | HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle Receives: Drug: HEC89736 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose
Incidence of dose limited toxicities and associated dose of HEC89736
Measured: Dosing started until the 28th day
Adverse events evaluated by NCI CTCAE 5.0
Incidence of adverse events and associated dose of HEC89736
Measured: From the frst dose to within 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Apr 2021
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Why it stopped: Adjustment to the sponsor's development strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-cell Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Jianyong, Doctor, Principal investigator, The First Affiliated Hospital with Nanjing Medical UniversitySong Yuqing, Doctor, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865458
- Sponsor's protocol ID
- HEC89736-P-01
- Status last verified
- May 2026
- First submitted
- 26 Apr 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04865458
- Acronym / sponsor ID
- HEC89736-P-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment to the sponsor's development strategy
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEC89736 treatment | Experimental | Drug: HEC89736HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC89736HEC89736 tablets QD every 28 days for each cycle | Drug | HEC89736 treatment |
Primary outcome
Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose
Time frame: Dosing started until the 28th day
Incidence of dose limited toxicities and associated dose of HEC89736
Adverse events evaluated by NCI CTCAE 5.0
Time frame: From the frst dose to within 30 days after the last dose
Incidence of adverse events and associated dose of HEC89736
Results and safety
The study was stopped early (reason given: Adjustment to the sponsor's development strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Jianyong, Doctor principal investigator
The First Affiliated Hospital with Nanjing Medical University
Song Yuqing, Doctor principal investigator
Peking University Cancer Hospital & Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEC89736 in people with Relapsed or Refractory B-cell Hematologic Malignancies, run by Sunshine Lake Pharma Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Adjustment to the sponsor's development strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose (time frame: Dosing started until the 28th day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.