A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-16

Study Completion Date

2027-12-31

Brief Summary

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This is a first-in-human (FIH) study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-R046 as a single agent and in combination with tislelizumab (BGB-A317) in participants with advanced or metastatic immune-sensitive solid tumors.

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Detailed Description

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Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1a: Part A: Dose Escalation Monotherapy

Sequential cohorts of increasing dose levels of BGB R046 will be evaluated as monotherapy.

Group Type EXPERIMENTAL

BGB-R046

Intervention Type DRUG

Intravenous administration

Phase 1a: Part B: Dose Escalation Combination Therapy

Sequential cohorts of increasing dose levels of BGB R046 will be evaluated in combination with tislelizumab.

Group Type EXPERIMENTAL

BGB-R046

Intervention Type DRUG

Intravenous administration

Tislelizumab

Intervention Type DRUG

Intravenous administration

Phase 1b: Dose Expansion and Dose Optimization

The recommended dose(s) for expansion (RDFE) for BGB-R046 in combination with tislelizumab from Phase 1a will be evaluated in selected indications.

Group Type EXPERIMENTAL

BGB-R046

Intervention Type DRUG

Intravenous administration

Tislelizumab

Intervention Type DRUG

Intravenous administration

Interventions

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BGB-R046

Intravenous administration

Intervention Type DRUG

Tislelizumab

Intravenous administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
* Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom standard treatment is not available, not tolerated, or determined not appropriate based on the investigator's judgement
* ≥ 1 measurable lesion per RECIST v1.1
* Able to provide an archived tumor tissue sample
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
* Adequate organ function
* Life expectancy \>12 weeks as determined by the investigator

Exclusion Criteria

* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
* Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s)
* History of interstitial lung disease, noninfectious pneumonitis (including immune mediated), or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.
* Experienced ≥ Grade 3 imAE(s) on prior immuno-oncology agent (anti-PD-1, anti CTLA4, or other experimental drugs)
* Uncontrolled diabetes \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drug(s).
* Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s)
* Immunodeficiency as assessed by the investigator to be not suitable for treatment with immune modulating anticancer agents

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No