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

BeiGene

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: BGB-R046; Drug: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06487858

BGB-R046-101

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 3 patient groups

Phase 1a: Part A: Dose Escalation Monotherapy

Experimental group

Description:

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

Treatment:

Drug: BGB-R046

Phase 1a: Part B: Dose Escalation Combination Therapy

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab

Drug: BGB-R046

Phase 1b: Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab

Drug: BGB-R046