An Investigational Study of BGB-58067 As a Single Agent a... | NCT06589596

ID	Type	Description	Link
2024-515307-19-00	EU Trial (CTIS) Number
CTR20244451	Registry Identifier	ChinaDrugTrials

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety Expansion	Experimental	Sequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.	Drug: BGB-58067
Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation	Experimental	Sequential cohorts of increasing dose levels of BGB-58067 in combination with BG-89894 will be evaluated. Enrollment in this combination has been discontinued.	Drug: BGB-58067 Drug: BG-89894
Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation	Experimental	Sequential cohorts of increasing dose levels of BGB-58067 in combination with standard of care therapy will be evaluated.	Drug: BGB-58067 Drug: Standard of Care Therapy
Phase 1b: Dose Expansion and Optimization	Experimental	Recommended Dose(s) for Expansion (RDFE[s]) of BGB-58067 alone and in combination with standard of care therapy will be evaluated for selected indications and regimen(s) based on emerging data.	Drug: BGB-58067 Drug: Standard of Care Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BGB-58067	Drug	Planned doses administered on specified days per protocol.	Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events	Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.	From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 13 months)
Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteria		Approximately 1 month
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy	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. Note: BGB-58067 + BG-89894 combination has been discontinued.	Approximately 1 month
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy	RDFE of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy will be determined based upon the MTD or MAD. Note: BGB-58067 + BG-89894 combination has been discontinued.	Approximately 13 months
Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone and in combination with standard of care therapy	RP2D established from Phase 1a for BGB-58067 alone and in combination with standard of care therapy for administration in selected tumor types.	Approximately 2 years
Phase 1b: Objective Response Rate (ORR)

Secondary Outcomes

Measure	Description	Time Frame
Phase 1a: Objective Response Rate (ORR)	ORR is defined as the percentage of participants with confirmed CR or PR, as assessed by the investigator.	Approximately 2 years
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-58067

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must sign the ICF and be capable of giving written informed consent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70
Life expectancy ≥ 3 months
Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue
Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing
Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose diseases have progressed or recurred after receiving standard systemic therapy or radiotherapy, or for whom standard systemic therapy is not available or tolerated, or would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard treatment in the opinion of the investigator; participants with advanced, metastatic, or unresectable solid tumors who have not received prior systemic treatment or have received one cycle of standard-of-care therapies will be enrolled in selected cohorts
Adequate organ function

Exclusion Criteria:

Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor
Active leptomeningeal disease or symptomatic spinal cord compression
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively
Significantly impaired pulmonary function
Clinically significant infections
Serologically active hepatitis B or C infection
Known HIV infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria
High cardiovascular risk factors
QTcF > 470 ms based on the screening triplicate 12-lead ECG records and/or a history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome)
Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized
Participants who are unable to swallow or with disease/procedure significantly affecting gastrointestinal function
Female participants who are pregnant or are breastfeeding
Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)

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

Name	Role	Phone	Extension	Email
Study Director	Contact	1.877.828.5568		clinicaltrials@beonemed.com

Name	Affiliation	Role
Study Director	BeOne Medicines	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Usc Norris Comprehensive Cancer Center (Nccc)	Recruiting	Los Angeles	California	90089-1019	United States

IPD Sharing Statement Module