Relapsed/Refractory B-Cell MalignanciesPhase 1NCT04861779
A Study of HSK29116 in Adults With Relapsed/Refractory B-cell Malignancies
A Phase 1 study testing HSK29116 in people with Relapsed/Refractory B-Cell Malignancies, run by Haisco Pharmaceutical Group Co., Ltd. at 8 sites in 2 countries.
Trial summary
This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of HSK29116 in patients with advanced B-cell malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory B-Cell Malignancies
- What is being tested?
- HSK29116
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 24 Aug 2021to Oct 2023
- 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
- Males or females, of any race, aged ≥ 18 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0- 2.
- Sufficient bone marrow function, hepatic function and Coagulation function.
- Patients must have measurable disease per disease-specific response criteria.
- Have histologically confirmed R/R CLL,SLL,MCL,Non-GCB DLBCL,FL(grade 1- 3a),MZL,WM.
- Received at least 2 prior systemic therapy and have no other therapies known to provide clinical benefit.
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- After the most recent treatment regimen, it is confirmed that PR has not been achieved, or there is confirmed progressive disease.
- Must require systemic therapy.
- The pregnancy test (urine or serum) of female subjects of childbearing potential shall be negative before enrollment.
- Female subjects of childbearing potential and fertile male subjects shall adopt one of the following highly effective contraception measures during the entire study and within 90 days after the study treatment is ended: abstinence, intrauterine device, or hormonal contraceptives beginning at least 3 months before the first dose of IMP.Male subjects are prohibited from donating sperm from the start of study treatment to 90 days after the end of treatment.
Who cannot join
- Subjects with central nervous system involvement.
- Subjects with histopathological transformation.
- Receipt of allogeneic hematopoietic stem cell transplantation ≤ 180 days before the start of study treatment administration on Cycle 1, Day 1, unless the subject is no longer on immunosuppressant medication. History of autologous hematopoietic stem cell transplantation within 12 weeks (84 days) before the start of study treatment.
- Continuous immunosuppressive therapy, including systemic (such as intravenous or oral) treatment with corticosteroids for the underlying diseases within 2 weeks before the first dose.
- Patients who have received BTKis, tyrosine kinase inhibitors or other targeted small molecule drugs for anti-tumor treatment within 7 days (or 5 half-lives, whichever is shorter) before initiation of study drug; or patients who have received any biological and/or immune-based anti-tumor treatment, including investigational treatment (including but not limited to monoclonal antibody therapy and/or anti-tumor vaccine) within 4 weeks (or 5 half-lives, whichever is shorter); or patients who have received systemic chemotherapy, radiotherapy or traditional Chinese medicines with anti-tumor effect (traditional Chinese medicines with anti-tumor indications specified in the package insert) within 2 weeks (or 5 half-lives, whichever is shorter).
- Previously developed toxicity due to anticancer treatment that did not resolve to Grade ≤ 1 (as per NCI-CTCAE 5.0), except for AEs not constituting a safety risk as assessed by the investigator.
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- A history of other malignant tumors within 2 years before enrollment, except for basal cell carcinoma or skin squamous cell carcinoma having been adequately treated, or without disease for ≥ 2 years or with other types of cancer with the survival time of greater than 2 years. Subjects with breast or prostate cancer who are on maintenance hormonal therapies following therapeutic procedures with curative intent are permitted.
- Uncontrolled systemic active infections, or other infections or still on intravenous anti-infection treatment.
- Underwent major surgery in the past 4 weeks.
- Known infection with human immunodeficiency virus, or serologic status reflecting active hepatitis B or C infection.
- Subjects with severe cardiovascular diseases within 6 months before screening.
- Left Ventricular Ejection Fraction < 50% based on either echocardiogram or multigated acquisition (MUGA) scan.
- QTcF ≥ 450 msecs for males and QTcF ≥ 470 msec for females or other significant ECG abnormalities.
- Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of drugs.
- Requiring or received anticoagulant therapy with warfarin or equivalent vitamin K antagonists (such as phenprocoumon) within 7 days before the first study treatment.
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura. Known history of bleeding diathesis.
- A history of stroke or intracranial hemorrhage within 6 months before the first study treatment.
- Use of CYP3A4 inhibitor or inducer within 7 days before the first study treatment, or using of sensitive substrates metabolized by CYP3A4/CYP2B6.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
China7 sites, 7 recruiting
- Recruiting
Hunan Cancer Hospita
Changsha, Hunan
Zhou Hui, doctor
- Not yet recruiting
NANFANG Hospital
Guangzhou, Guangdong
Ru Feng, Doctor
- Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wenbin Qian, Doctor
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang
zhen cai, doctor
jian liu, doctor
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong
Xin Wang, Doctor
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Jianyong Li, Doctor
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Keshu Zhou, doctor
Australia1 site, 1 recruiting
- Not yet recruiting
One Clinical Research
Perth
Peter Tan, Doctor
About this study
Official title: A Phase Ia/b Clinical Study on Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of BTK Protein Degradation Agent HSK29116 in Subjects With Relapsed or Refractory B-Cell Malignancy
This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of HSK29116 in patients with advanced B-cell malignancies.
Read the detailed description
This study is divided into 2 parts. Phase 1a is a dose escalation to evaluate the safety and tolerability of HSK29116 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapy and for whom no other therapies are known to provide clinical benefit. Phase 1b will investigate the efficacy of HSK29116 at the dose selected in Phase 1a in up to 3 cohorts of patients with R/R B-cell malignancy indications who have received at least 2 prior systemic therapy：
Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)； Mantle Cell Lymphoma (MCL)； Other B-cell malignancies (they will be selected according to the preliminary results of Phase Ia)
- Conditions
- Relapsed/Refractory B-Cell Malignancies
- Being tested
- HSK29116
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK29116Drug
Oral HSK29116
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Multiple dose levels of HSK29116 to be evaluated; determination of MTD/Phase 1b recommended dose Receives: Drug: HSK29116 |
| Phase 1b Dose Expansion in R/R CLL or SLL | Experimental | CLL/SLL patients must have received at least one systemic treatment and failed or relapsed, of which at least half of the subjects must have received covalent BTK inhibitors and have BTK C481 mutation. Receives: Drug: HSK29116 |
| Phase 1b Dose Expansion in R/R MCL | Experimental | MCL patients must have received at least one systemic treatment and failed or relapsed, of which at least half of the subjects must have received covalent BTK inhibitors and have BTK C481 mutation. Receives: Drug: HSK29116 |
| Phase 1b Dose Expansion in other R/R B-cell Malignancy | Experimental | Patients must have received at least one systemic treatment and failed or relapsed, of which at least half of the subjects must have received covalent BTK inhibitors and have BTK C481 mutation. Receives: Drug: HSK29116 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Protocol Specified Dose-Limiting Toxicities
Phase 1a
Measured: 1 year
To establish the MTD and/or recommended Phase 1b dose of HSK29116
Phase 1a
Measured: 1 year
Number of Participants with Adverse Events and Clinical Laboratory Abnormalities
Phase 1a/1b
Measured: Up to 3 years
Secondary outcomes (5)
Pharmacokinetic(PK) Profile of HSK29116: Maximum Serum Concentration
Phase1a/1b-Sampling of the first dose, pre and post-dose at selected cycle
Measured: At the end of Cycle 1 (each cycle is 28 days)
Overall response rate(ORR) as assessed by the Investigator
Phase 1a/1b
Measured: Up to 3 Years
Duration of response(DoR) as assessed by the Investigator
Phase 1a/1b
Measured: Up to 3 Years
Progression-free survival(PFS) as assessed by the Investigator
Phase 1a/1b
Measured: Up to 3 Years
Time to response(TTR) as assessed by the Investigator
Phase 1a/1b
Measured: Up to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start24 Aug 2021
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory B-Cell MalignanciesStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shufang Zhang, Study director, Haisco Pharmaceutical Group Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861779
- Sponsor's protocol ID
- HSK29116-101
- Status last verified
- Aug 2022
- First submitted
- 20 Apr 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/b Clinical Study on Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of BTK Protein Degradation Agent HSK29116 in Subjects With Relapsed or Refractory B-Cell Malignancy
- ClinicalTrials.gov ID
- NCT04861779
- Acronym / sponsor ID
- HSK29116-101
- Conditions
- Relapsed/Refractory B-Cell Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 27 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.
This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of HSK29116 in patients with advanced B-cell malignancies.
Detailed description
This study is divided into 2 parts. Phase 1a is a dose escalation to evaluate the safety and tolerability of HSK29116 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapy and for whom no other therapies are known to provide clinical benefit. Phase 1b will investigate the efficacy of HSK29116 at the dose selected in Phase 1a in up to 3 cohorts of patients with R/R B-cell malignancy indications who have received at least 2 prior systemic therapy：
Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)； Mantle Cell Lymphoma (MCL)； Other B-cell malignancies (they will be selected according to the preliminary results of Phase Ia)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: HSK29116Multiple dose levels of HSK29116 to be evaluated; determination of MTD/Phase 1b recommended dose |
| Phase 1b Dose Expansion in R/R CLL or SLL | Experimental | Drug: HSK29116CLL/SLL patients must have received at least one systemic treatment and failed or relapsed, of which at least half of the subjects must have received covalent BTK inhibitors and have BTK C481 mutation. |
| Phase 1b Dose Expansion in R/R MCL | Experimental | Drug: HSK29116MCL patients must have received at least one systemic treatment and failed or relapsed, of which at least half of the subjects must have received covalent BTK inhibitors and have BTK C481 mutation. |
| Phase 1b Dose Expansion in other R/R B-cell Malignancy | Experimental | Drug: HSK29116Patients must have received at least one systemic treatment and failed or relapsed, of which at least half of the subjects must have received covalent BTK inhibitors and have BTK C481 mutation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females, of any race, aged ≥ 18 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0- 2.
- Sufficient bone marrow function, hepatic function and Coagulation function.
- Patients must have measurable disease per disease-specific response criteria.
- Have histologically confirmed R/R CLL,SLL,MCL,Non-GCB DLBCL,FL(grade 1- 3a),MZL,WM.
Key exclusion criteria (18 listed)
- Subjects with central nervous system involvement.
- Subjects with histopathological transformation.
- Receipt of allogeneic hematopoietic stem cell transplantation ≤ 180 days before the start of study treatment administration on Cycle 1, Day 1, unless the subject is no longer on immunosuppressant medication. History of autologous hematopoietic stem cell transplantation within 12 weeks (84 days) before the start of study treatment.
- Continuous immunosuppressive therapy, including systemic (such as intravenous or oral) treatment with corticosteroids for the underlying diseases within 2 weeks before the first dose.
- Patients who have received BTKis, tyrosine kinase inhibitors or other targeted small molecule drugs for anti-tumor treatment within 7 days (or 5 half-lives, whichever is shorter) before initiation of study drug; or patients who have received any biological and/or immune-based anti-tumor treatment, including investigational treatment (including but not limited to monoclonal antibody therapy and/or anti-tumor vaccine) within 4 weeks (or 5 half-lives, whichever is shorter); or patients who have received systemic chemotherapy, radiotherapy or traditional Chinese medicines with anti-tumor effect (traditional Chinese medicines with anti-tumor indications specified in the package insert) within 2 weeks (or 5 half-lives, whichever is shorter).
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 |
|---|---|---|
| HSK29116Oral HSK29116 | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion in R/R CLL or SLL, Phase 1b Dose Expansion in R/R MCL, Phase 1b Dose Expansion in other R/R B-cell Malignancy |
Primary outcome
Number of Participants with Protocol Specified Dose-Limiting Toxicities
Time frame: 1 year
Phase 1a
To establish the MTD and/or recommended Phase 1b dose of HSK29116
Time frame: 1 year
Phase 1a
Number of Participants with Adverse Events and Clinical Laboratory Abnormalities
Time frame: Up to 3 years
Phase 1a/1b
5 secondary outcomes
Pharmacokinetic(PK) Profile of HSK29116: Maximum Serum Concentration
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall response rate(ORR) as assessed by the Investigator
Time frame: Up to 3 Years
Duration of response(DoR) as assessed by the Investigator
Time frame: Up to 3 Years
Progression-free survival(PFS) as assessed by the Investigator
Time frame: Up to 3 Years
Time to response(TTR) as assessed by the Investigator
Time frame: Up to 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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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.
Shufang Zhang study director
Haisco Pharmaceutical Group Co., Ltd.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK29116 in people with Relapsed/Refractory B-Cell Malignancies, run by Haisco Pharmaceutical Group Co., Ltd. at 8 sites in 2 countries.
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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China, Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue Gu (86-13840370891, gux@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Protocol Specified Dose-Limiting Toxicities (time frame: 1 year). The study lists 3 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 3 Aug 2022.