Trials Sponsors Conditions Drugs Pricing

Conditions

Relapsed/Refractory B-Cell Malignancies

Outcome Measures

Primary Outcomes (3)

Number of Participants with Protocol Specified Dose-Limiting Toxicities
Phase 1a
1 year
To establish the MTD and/or recommended Phase 1b dose of HSK29116
Phase 1a
1 year
Number of Participants with Adverse Events and Clinical Laboratory Abnormalities
Phase 1a/1b
Up to 3 years

Secondary Outcomes (5)

Pharmacokinetic(PK) Profile of HSK29116: Maximum Serum Concentration
At the end of Cycle 1 (each cycle is 28 days)
Overall response rate(ORR) as assessed by the Investigator
Up to 3 Years
Duration of response(DoR) as assessed by the Investigator
Up to 3 Years
Progression-free survival(PFS) as assessed by the Investigator
Up to 3 Years
Time to response(TTR) as assessed by the Investigator
Up to 3 Years

Study Arms (4)

Phase 1a Dose Escalation

EXPERIMENTAL

Multiple dose levels of HSK29116 to be evaluated; determination of MTD/Phase 1b recommended dose

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.

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.

Interventions

HSK29116Drug

Oral HSK29116

Phase 1a Dose EscalationPhase 1b Dose Expansion in R/R CLL or SLLPhase 1b Dose Expansion in R/R MCLPhase 1b Dose Expansion in other R/R B-cell Malignancy

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:

Males or females, of any race, aged ≥ 18 years.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0- 2.

Sponsors & Collaborators

Haisco Pharmaceutical Group Co., Ltd.
Industrylead

Study Sites (8)

One Clinical Research

Perth, Australia

NOT_YET_RECRUITING

Peter Tan, DoctorCONTACT

NANFANG Hospital

Guangzhou, Guangdong, China

NOT_YET_RECRUITING

Ru Feng, DoctorCONTACT

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Shufang Zhang
Haisco Pharmaceutical Group Co., Ltd.
STUDY DIRECTOR

Central Study Contacts

Xue Gu

CONTACT

86-13840370891 gux@haisco.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 27, 2021

Study Start

August 24, 2021

Actual (reported)

Primary Completion

August 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

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.
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.
+3 more criteria

A Study of HSK29116 in Adults With Relapsed/Refractory B-cell Malignancies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (4)

Phase 1a Dose Escalation

Phase 1b Dose Expansion in R/R CLL or SLL

Phase 1b Dose Expansion in R/R MCL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Phase 1b Dose Expansion in other R/R B-cell Malignancy

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (4)

Phase 1a Dose Escalation

Phase 1b Dose Expansion in R/R CLL or SLL

Phase 1b Dose Expansion in R/R MCL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Phase 1b Dose Expansion in other R/R B-cell Malignancy

You may not qualify if:

Source record

Locations