AzTrials
AzTrials

Advanced CancerPhase 1NCT06540066

A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors

A Phase 1 study testing BGB-B3227, Tislelizumab and Chemotherapy in people with Advanced Cancer and Advanced Solid Tumor, run by BeiGene at 12 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of BGB-B3227, a humanized immunoglobulin G1 (IgG1) antibody. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-B3227 as a… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BGB-B3227, Tislelizumab and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
12 sitesin 3 countries
Study dates
11 Sep 2024to 9 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors with a high prevalence of mucin-1 (MUC1) expression
  • At least 1 measurable lesion per RECIST v1.1
  • Stable Eastern Cooperative Oncology Group Performance Status of ≤ 1
  • Adequate organ function
  • Willing to use a highly effective method of birth control

Who cannot join

  • History of prior ≥ Grade 3 Cytokine Release Syndrome (CRS)
  • History of severe Infusion-Related Reactions (IRRs), allergic reactions, or hypersensitivity to any ingredients or components of the study treatments
  • Infection requiring systemic (oral or intravenous) therapy ≤ 14 days before the first dose of study drug(s), or participants with symptomatic COVID-19 infection
  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Active autoimmune disease or history of autoimmune disease(s) that may relapse
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

United States5 sites

  • Next Oncology

    Austin, Texas, 78758

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601-1915

  • Md Anderson Cancer Center

    Houston, Texas, 77030-3907

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California, 90089-1019

  • Washington University in St Louis

    St Louis, Missouri, 63110-1010

Other trials in United States

Italy4 sites

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133

  • Istituto Europeo Di Oncologia

    Milan, 20141

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

China3 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Multicenter, Open-label, Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B3227 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced or Metastatic Solid Tumors

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of BGB-B3227, a humanized immunoglobulin G1 (IgG1) antibody. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-B3227 as a monotherapy or in combination with tislelizumab with or without chemotherapy in participants with selected advanced or metastatic solid tumors. The study will also identify recommended dose(s) for expansion (RDFE[s]) of BGB-B3227 administered alone and in combination with tislelizumab.

Being tested
BGB-B3227, Tislelizumab, Chemotherapy
Keywords
BGB-B3227, tislelizumab, BGB-A317, advanced solid tumor, metastatic solid tumor
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-B3227Drug

    Administered intravenously.

  • TislelizumabDrug

    Also called BGB-A317

    Administered intravenously.

  • ChemotherapyDrug

    Administered in accordance with relevant local guidelines and/or prescribing information.

Study groups in NCT06540066
Study groupRoleWhat they receive
Phase 1a Part A: Dose Escalation (BGB-B3227 Monotherapy)ExperimentalSequential cohorts of increasing dose levels of BGB-B3227 will be evaluated as monotherapy.
Receives: Drug: BGB-B3227
Phase 1a Part B: Dose Escalation (BGB-B3227 + tislelizumab)ExperimentalSequential cohorts of increasing dose levels of BGB-B3227 will be evaluated in combination with tislelizumab.
Receives: Drug: BGB-B3227; Drug: Tislelizumab
Phase 1b: Dose ExpansionExperimentalSequential cohorts of increasing dose levels of BGB-B3227 will be evaluated in combination with tislelizumab and chemotherapy.
Receives: Drug: BGB-B3227; Drug: Tislelizumab; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with AEs and SAEs, including findings from physical examinations, laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Special Interest (AESI) criteria.

    Measured: From first dose of the study drug(s) to 30 days after the last dose or 90 days after last dose of tislelizumab, approximately 9 months

  2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)

    MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.

    Measured: Approximately 9 months

  3. Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-B3227

    RDFE of BGB-B3227 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.

    Measured: Approximately 9 months

  4. Phase 1b: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

    Measured: From first dose of study drug(s) until progressive disease or new anticancer treatment; approximately 12 months

  5. Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-B3227

    RP2D established from Phase 1a for BGB-B3227 for administration in combination with tislelizumab and chemotherapy in selected tumor types.

    Measured: Approximately 12 months

Secondary outcomes (13)

  1. Phase 1a: ORR

    ORR is defined as the percentage of participants with confirmed best overall response of CR or PR, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

    Measured: From first dose of study drug(s) until progressive disease or new anticancer treatment; approximately 6 months

  2. Phase 1b: Progression-Free Survival (PFS)

    PFS is defined as the time from the first dose of study treatment to the date of first documentation of disease progression or death, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.

    Measured: From first dose of study drug(s) until progressive disease or new anticancer treatment; approximately 12 months

  3. Phase 1b: Number of Participants with AEs and SAEs

    Number of participants with AEs and SAEs, including findings from physical examinations, laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Special Interest (AESI) criteria.

    Measured: From first dose of the study drug(s) to 30 days after the last dose, or 90 days after last dose of tislelizumab; approximately 12 months

  4. Phase 1a and 1b: Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who achieve confirmed CR, PR, or stable disease, as assessed by the investigator per RECIST Version 1.1.

    Measured: From first dose of study treatment drug(s) until confirmed response or stable disease; approximately 6 months for Phase 1a and 12 months for Phase 1b

  5. Phase 1a and 1b: Duration of Response (DoR)

    DoR is defined as the time from the first confirmed objective response to disease progression documented after treatment initiation or death, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.

    Measured: From confirmed response to disease progression or death; approximately 6 months for Phase 1a and 12 months for Phase 1b

  6. Phase 1a and 1b: Serum Concentrations of BGB-B3227

    Measured: From first dose of BGB-B3227 up to 30 days after last dose of BGB-B3227; approximately 6 months for Ph1a and 12 months for Ph1b

  7. Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BGB-B3227

    Measured: From first dose of BGB-B3227 up to 30 days after last dose of BGB-B3227; approximately 6 months for Phase 1a and 12 months for Phase 1b

  8. Phase 1a: Area under the Curve (AUC) of BGB-B3227

    Measured: Approximately 4 months

  9. Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-B3227

    Measured: Approximately 4 months

  10. Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-B3227

    Measured: Approximately 4 months

  11. Phase 1a: Trough concentration (Ctrough) of BGB-B3227

    Measured: Approximately 4 months

  12. Phase 1a: Accumulation ratio of BGB-B3227

    Measured: Approximately 4 months

  13. Phase 1a: Terminal half-life (t1/2) of BGB-B3227

    Measured: Approximately 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start11 Sep 2024
  3. Primary completion9 Jan 2026
  4. Study completion9 Jan 2026

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06540066
Sponsor's protocol ID
BGB-B3227-101
Other IDs
2024-514216-27-00, CTR20244018
Status last verified
Mar 2026
First submitted
2 Aug 2024
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BGB-B3227, Tislelizumab and Chemotherapy in people with Advanced Cancer and Advanced Solid Tumor, run by BeiGene at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Italy, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From first dose of the study drug(s) to 30 days after the last dose or 90 days after last dose of tislelizumab, approximately 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06540066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in