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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Oral HSK29116
One Clinical Research
Perth, Australia
NOT_YET_RECRUITINGNANFANG Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
Number of Participants with Protocol Specified Dose-Limiting Toxicities
Phase 1a
Time frame: 1 year
To establish the MTD and/or recommended Phase 1b dose of HSK29116
Phase 1a
Time frame: 1 year
Number of Participants with Adverse Events and Clinical Laboratory Abnormalities
Phase 1a/1b
Time frame: Up to 3 years
Pharmacokinetic(PK) Profile of HSK29116: Maximum Serum Concentration
Phase1a/1b-Sampling of the first dose, pre and post-dose at selected cycle
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall response rate(ORR) as assessed by the Investigator
Phase 1a/1b
Time frame: Up to 3 Years
Duration of response(DoR) as assessed by the Investigator
Phase 1a/1b
Time frame: Up to 3 Years
Progression-free survival(PFS) as assessed by the Investigator
Phase 1a/1b
Time frame: Up to 3 Years
Time to response(TTR) as assessed by the Investigator
Phase 1a/1b
Time frame: Up to 3 Years
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Hunan Cancer Hospita
Changsha, Hunan, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGShandong Provincial Hospital
Jinan, Shandong, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China
RECRUITING