Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

Health ProfessionalsPatients

RecruitingLast updated: 21 January 2025

PROTAC+: This study is recruiting people with relapsed or refractory B-cell blood cancers to evaluate a targeted therapy (called BGB-16673) in combination with other drugsA Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

PROTAC+

Clinical summary

Summary

The purpose of this study is to measure how safe and helpful a targeted therapy drug called BGB-16673 when given in combination with other targeted medicines. BGB-16673 is a drug that targets and damages Bruton's tyrosine kinase (BTK), which helps stop the growth of cancerous B-cells that overexpress BTK.

This study is structured as a master protocol with separate substudies. This study will initially include two substudies, and more substudies may be added as they become available.

In Substudy 1, participants will receive BGB-16673 in combination with Sonrotoclax targeted therapy. In Substudy 2, participants will receive BGB-16673 in combination with Zanubrutinib targeted therapy. All will be given as oral capsules.

Each substudy has two parts:

  • Dose Escalation, where sequential cohorts of increasing dose level combinations will be evaluated; and
  • Safety Expansion, where cohorts of select dose level combinations will be evaluated.

Conditions

This trial is treating people with B-cell malignancies that have either come back (relapsed) or not responded to (refractory) prior treatment

Eligibility

Inclusion

  • Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF
  • Confirmed diagnosis of a R/R B-cell malignancy
  • Protocol-defined measurable disease
  • Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  • Adequate organ function
  • Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, or 90 days after the last dose of sonrotoclax. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment
  • Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, or 90 days after the last dose of sonrotoclax

  • Substudy 2 Inclusion Criteria:

    • Bruton tyrosine kinase (BTK) inhibitor-naive, or
    • Previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression

Exclusion

  • Treatment-naive B-cell malignancies
  • Unable to comply with the requirements of the protocol
  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively
  • Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening
  • Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
  • Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, or zanubrutinib

  • Substudy 1 Exclusion Criterion:

    • Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor

  • Substudy 2 Exclusion Criterion:

    • Participants who discontinued prior zanubrutinib treatment due to intolerance

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

BeiGene

Scientific Title

A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Get Support

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Cancer Connect

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

HelpThis verification step helps prevent fraudulent transactions from automated software.
Submitting ... Please wait