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

NCT06487858 | Terminated Phase 1

• 1 other identifier: BGB-R046-101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Solid Tumor

Keywords

BGB-R046; First-in-human; Advanced solid tumor; Anti-Programmed Death-1 (Anti-PD1)

Outcome Measures

Primary Outcomes (4)

• Phase 1a: Number of Participant with Adverse Events, Serious Adverse Events, Adverse Events of Clinical Interest and Dose-limiting Toxicities

  Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT) for cytokine release syndrome \[CRS\] and immune effector cell associated neurotoxicity syndrome \[ICANS\])

  Up to approximately 2 years

• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-R046

  MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively

  Up to approximately 2 years

• Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-R046

  The potential RDFE\[s\] of BGB-R046 administered as monotherapy and in combination with tislelizumab will be determined based on the totality of the data and will also take in consideration the long term tolerability, pharmacokinetics, preliminary antitumor activity and any other relevant data available

  Up to approximately 2 years

• Phase 1b: Overall Response Rate (ORR)

  ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to approximately 2 years

Secondary Outcomes (15)

• Phase 1a: ORR

  Up to approximately 2 years

• Phase 1a: Time to Response (TTR)

  Up to approximately 2 years

• Phase 1a: Clinical Benefit Rate (CBR)

  Up to approximately 2 years

• Phase 1a and Phase 1b: Duration of Response (DOR)

  Up to approximately 2 years

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

  Up to approximately 2 years

Study Arms (3)

Phase 1a: Part A: Dose Escalation Monotherapy

EXPERIMENTAL

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

Drug: BGB-R046

Phase 1a: Part B: Dose Escalation Combination Therapy

EXPERIMENTAL

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

Drug: BGB-R046; Drug: Tislelizumab

Phase 1b: Dose Expansion and Dose Optimization

EXPERIMENTAL

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

Drug: BGB-R046; Drug: Tislelizumab

Interventions

BGB-R046 DRUG

Intravenous administration

Phase 1a: Part A: Dose Escalation Monotherapy; Phase 1a: Part B: Dose Escalation Combination Therapy; Phase 1b: Dose Expansion and Dose Optimization

Tislelizumab DRUG

Intravenous administration

Phase 1a: Part B: Dose Escalation Combination Therapy; Phase 1b: Dose Expansion and Dose Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (8)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

Location

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Jining No1 Peoples Hospital West Branch

Jining, Shandong, 272000, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

tislelizumab

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 5, 2024
• Study Start: July 16, 2024
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (8)