Treatment of Chinese Patients With B-Cell Malignancies With BGB-16673, a Burton Tyrosine Kinase-Targeted Protein-Degrader
Study Details
Study Description
Brief Summary
This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Part 1 (Dose Finding) BGB-16673 will be orally administered |
Drug: BGB-16673
BGB-16673 will be orally administered as per dosage needs
|
Experimental: Part 2 (Dose Expansion) BGB-16673 will be administered at the recommended Phase 2 dose (RP2D) that was identified in Part 1 |
Drug: BGB-16673
BGB-16673 will be orally administered as per dosage needs
|
Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events (AEs) [Up to 5 year]
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
- Recommended Phase 2 Dose (RP2D) based on Maximum tolerated dose (MTD) of BGB-16673 [Up to 5 years]
The dose recommended by the iBOIN design or the MAD and RP2D as determined by the sponsor based on the Safety Monitoring Committee's recommendation considering totality of the available clinical safety, clinical efficacy, PK, and PD dataThe
Secondary Outcome Measures
- Maximum observed plasma concentration (Cmax) of BGB-16673 [Up to Week 8]
- Time to reach maximum observed plasma concentration (Tmax) of BGB-16673 [Up to Week 8]
- Minimum observed plasma concentration (Cmin) of BGB-16673 [Up to Week 8]
- Apparent terminal elimination half life (t1/2) of BGB-16673 [Up to Week 8]
- Area under the plasma-concentration curve (AUC) of BGB-16673 [Up to Week 8]
- Apparent oral clearance (CL/F) of of BGB-16673 [Up to Week 8]
- Apparent volume of distribution (Vz/F) of BGB-16673 [Up to Week 8]
- Accumulation ratios of BGB-16673 [Up to Week 8]
- Maximum observed steady state plasma concentration (Css,max) of of BGB-16673 [Up to Week 8]
- Time to reach maximum observed steady state plasma concentration (Tss,max) of BGB-16673 [Up to Week 8]
- Minimum observed steady state plasma concentration (Css,min) of BGB-16673 [Up to Week 8]
- Steady state apparent oral plasma clearance (CL/F) of BGB-16673 [Up to Week 8]
- Steady state apparent volume of distribution (Vss/F) of BGB-16673 [Up to Week 8]
- BTK protein degradation in peripheral blood upon BGB-16673 monotherapy [Up to Week 4]
- Overall Response Rate (ORR) [Up to 5 years]
ORR is defined as the percentage of participants with partial or complete response, as assessed using iwCLL, Owen, and Lugano criteria
- Major Response Rate (MRR) [Up to 5 years]
MRR is defined as the percentage of participants who achieved complete response (CR) + very good partial response (VGPR) + partial response (PR), as assessed by iwCLL, Owen, and Lugano criteria for participants with WM only
Eligibility Criteria
Criteria
Key Inclusion Criteria
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Provision of signed and dated written informed consent prior to any study, Age ≥ 18 years
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ECOG Performance Status of 0 to 2
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Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria
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Confirmed diagnosis of R/R MZL, FL (grade 1-3a), MCL, CLL/SLL, WM and previously treated
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Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug
Key Exclusion Criteria
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Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
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Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment
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Receiving treatment with a strong CYP3A inhibitor or inducer, or proton-pimp inhibitors ≤ 14 days before the first dose of BGB-16673.
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Current or history of central nervous involvement
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Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Peking University Third Hospital | Beijing | Beijing | China | 100191 |
2 | West China Hospital of Sichuan University | Sichuan | Chengdu | China | |
3 | Xinqiao Hospital Affiliated to The Army Medical University | Chongqing | Chongqing | China | 400030 |
4 | Sun Yat- Sen University Cancer Center (Huangpu Campus) | Guanzhou | Guangdong | China | |
5 | Henan Cancer Hospital | Zhengzhou | Henan | China | 450000 |
6 | Shandong Cancer Hospital | Jinan | Shandong | China | 250117 |
7 | Ruijin Hospital, Shanghai JiaoTong University School of Medicine | Shanghai | Shanghai | China | 200000 |
8 | Rui Jin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | |
9 | The First Affiliated Hospital, Zhejiang University School of Medicine | Zhejiang | China |
Sponsors and Collaborators
- BeiGene
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BGB-16673-102