Evaluating BGB-R046 alone and with Tislelizumab in solid tumors

A Multicenter Open-Label Phase 1a/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors

This study is testing a new drug called BGB-R046, alone and with another drug called tislelizumab, to see if it can help people with advanced solid tumors that haven't responded to standard treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BeiGene (industry)
• Drugs / interventions: prednisone, tislelizumab
• Locations: 8 sites (Fuzhou, Fujian and 7 other locations)
• Trial ID: NCT06487858 on ClinicalTrials.gov

What this trial studies

This first-in-human study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-R046, both as a monotherapy and in combination with tislelizumab, in patients with advanced or metastatic immune-sensitive solid tumors. Participants will be required to have previously received standard systemic therapy or have no available treatment options. The study will involve measuring the response of at least one measurable lesion according to RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced, metastatic, and unresectable solid tumors who have previously undergone standard systemic therapy.

Not a fit: Patients with active leptomeningeal disease, uncontrolled brain metastasis, or active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited therapeutic alternatives.

How similar studies have performed: Other studies involving anti-PD1 therapies have shown promising results, suggesting potential success for this novel combination approach.

Eligibility criteria

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.

Where this trial is running

Fuzhou, Fujian and 7 other locations

• Fujian Cancer Hospital — Fuzhou, Fujian, China (RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (RECRUITING)
• Union Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
• Jinan Central Hospital — Jinan, Shandong, China (RECRUITING)
• Jining No Peoples Hospital West Branch — Jining, Shandong, China (RECRUITING)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai, China (RECRUITING)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Study Director

Conditions: Solid Tumor, BGB-R046, First-in-human, Advanced solid tumor, Anti-Programmed Death-1