Treatment of Chinese Patients With B-Cell Malignancies With BGB-16673, a Burton Tyrosine Kinase-Targeted Protein-Degrader

Brief Title

Treatment of Chinese Patients With B-Cell Malignancies With BGB-16673, a Burton Tyrosine Kinase-Targeted Protein-Degrader

Official Title

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies

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

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Number of participants with adverse events (AEs)

Secondary Outcome

 Maximum observed plasma concentration (Cmax) of BGB-16673

Condition

B-cell Malignancy, Low-grade

Intervention

BGB-16673

Study Arms / Comparison Groups

 Part 1 (Dose Finding)

Description:  BGB-16673 will be orally administered

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

March 24, 2022

Completion Date

March 2027

Primary Completion Date

March 2027

Eligibility Criteria

        Key Inclusion Criteria

          1. Provision of signed and dated written informed consent prior to any study, Age ≥ 18
             years

          2. ECOG Performance Status of 0 to 2

          3. Adequate organ function of coagulation function, liver function, renal function and
             pancreatic function and measure disease per disease-specific response criteria

          4. Confirmed diagnosis of R/R MZL, FL (grade 1-3a), MCL, CLL/SLL, WM and previously
             treated

          5. 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

          1. 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

          2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid
             treatment

          3. Receiving treatment with a strong CYP3A inhibitor or inducer, or proton-pimp
             inhibitors ≤ 14 days before the first dose of BGB-16673.

          4. Current or history of central nervous involvement

          5. 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 1.877.828.5568, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT05294731

Organization ID

BGB-16673-102

Responsible Party

Sponsor

Study Sponsor

BeiGene

Study Sponsor

, ,

Verification Date

April 2022