An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (NCT06589596) — China Trial Details

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

BGB-58067BG-89894Standard of Care Therapy

BGB-58067: Planned doses administered on specified days per protocol.

BG-89894: Planned doses administered on specified days per protocol.

Standard of Care Therapy: Administered in accordance with relevant local guidelines and/or prescribing information.

Study summary

This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

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.

Primary outcome measure(s)

Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events — 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)
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.
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 — Approximately 1 month
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.
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 — Approximately 13 months
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.
Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone and in combination with standard of care therapy — Approximately 2 years
RP2D established from Phase 1a for BGB-58067 alone and in combination with standard of care therapy for administration in selected tumor types.
Phase 1b: Objective Response Rate (ORR) — Approximately 2 years
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), as assessed by the investigator.

Trial sites (101)

Facility	City	Region	Status
Cancer and Blood Specialty Clinic	Los Alamitos	California	Recruiting
Usc Norris Comprehensive Cancer Center (Nccc)	Los Angeles	California	Recruiting
Adventhealth	Celebration	Florida	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	Recruiting
Washington University School of Medicine	St Louis	Missouri	Recruiting
Nyu Langone Health	New York	New York	Recruiting
Columbia University Medical Center	New York	New York	Recruiting
Sidney Kimmel Cancer Center	Philadelphia	Pennsylvania	Recruiting
Tennessee Oncology, Pllc Nashville	Nashville	Tennessee	Recruiting
The University of Texas Md Anderson Cancer Center	Houston	Texas	Recruiting
Next Oncology Dallas	Irving	Texas	Recruiting
Next Oncology Virginia	Fairfax	Virginia	Recruiting
Blacktown Cancer and Haematology Centre	Blacktown	New South Wales	Recruiting
Princess Alexandra Hospital	Woolloongabba	Queensland	Recruiting
Monash Health	Clayton	Victoria	Recruiting
Austin Health	Heidelberg	Victoria	Recruiting
Linear Clinical Research	Nedlands	Western Australia	Recruiting
Fundacao Pio Xii Hospital de Amor de Barretos	Barretos	Brazil	Recruiting
Fundacao Universidade de Caxias Do Sul	Caxias do Sul	Brazil	Recruiting
Liga Norte Riograndene Contra O Cancer	Natal	Brazil	Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus	Porto Alegre	Brazil	Recruiting
Hospital Sao Lucas Da Pucrs	Porto Alegre	Brazil	Recruiting
Ensino E Terapia de Inovacao Clinica Amo Etica	Salvador	Brazil	Recruiting
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira	São Paulo	Brazil	Recruiting
Nucleo de Pesquisa E Ensino Da Rede Sao Camilo	São Paulo	Brazil	Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	São Paulo	Brazil	Recruiting
Hospital Santa Rita de Cassia Afecc	Vitória	Brazil	Recruiting
The Second Hospital of Anhui Medical University	Hefei	Anhui	Recruiting
Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing Municipality	Recruiting
Beijing Cancer Hospital	Beijing	Beijing Municipality	Recruiting
Peking Union Medical College Hospital	Beijing	Beijing Municipality	Recruiting
Beijing Chest Hospital, Capital Medical University	Beijing	Beijing Municipality	Recruiting
Chongqing University Cancer Hospital	Chongqing	Chongqing Municipality	Recruiting
Fujian Cancer Hospital	Fuzhou	Fujian	Recruiting
The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	Recruiting
Sun Yat Sen University Cancer Center	Guangzhou	Guangdong	Recruiting
The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	Recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)	Guangzhou	Guangdong	Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong	Recruiting
Meizhou People Hospital	Meizhou	Guangdong	Recruiting

+ 61 more sites — see the full list on the official registry below.

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