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An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started2025-01-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Contacts/Locations v29
Trial sites expanded: 98 → 101 locations
2026-07-21
Study Status, Contacts/Locations v28
Study sites96→98
2026-07-10
Study Status, Contacts/Locations v27
Trial sites expanded: 92 → 96 locations
2026-06-18
Study Status, Contacts/Locations v26
Trial sites expanded: 87 → 92 locations
2026-06-01
Study Status, Contacts/Locations v25
Trial sites expanded: 82 → 87 locations
2026-05-21
Study Status, Contacts/Locations v24
Study sites80→82
2026-05-07
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v23
Primary endpoint(s) modified6 entries, revised
WasPhase 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, Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events, Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteria, 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, Phase 1b: Objective Response Rate (ORR), Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy
NowPhase 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, Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events, Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteria, 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, Phase 1b: Objective Response Rate (ORR), Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone and in combination with standard of care therapy
Enrollment increased: 244 → 525 participants
Trial sites expanded: 62 → 80 locations
Primary completion moved earlier: 2029-01 → 2027-09-30
Completion moved earlier: 2029-01 → 2027-09-30
Start date2024-10-11→2025-01-10
Study description+15 characters
[...] This drug will be tested alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in partic [...]
2026-03-17
Study Status, Contacts/Locations v22
Study sites59→62
2026-03-03
Study Status, Contacts/Locations v21
Study sites47→59
2026-02-19
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 47 sites
2026-02-05
Study Status, Contacts/Locations v19
Study sites45→47
2026-01-22
Study Status, Contacts/Locations v18
Study sites44→45
2026-01-13
Study Status v17
Re-verified, no change to tracked fields
2025-12-18
Study Status, Sponsor/Collaborators, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v16
Primary completion date2027-06→2029-01
Completion date2027-06→2029-01
Enrollment target237→244
Study sites41→44
Lead sponsorBeiGene→BeOne Medicines
Eligibility criteria+211 characters
[...] priate 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 [...]
Study description+216 characters
[...] cipants with advanced solid tumors and with MTAP deficiency. Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
2025-11-10
Study Status, Contacts/Locations v15
Study sites36→41
2025-10-22
Study Identification, Study Status, Contacts/Locations v14
Study sites45→36
2025-09-19
2 amendments v12-v13
2 re-verifications since 2025-09-11, no change to tracked fields
2025-08-29
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v11
Primary completion date2026-11→2027-06
Completion date2026-11→2027-06
Enrollment target92→237
Study arms2→4
InterventionsBGB-58067 (Drug)→BG-89894 (Drug), BGB-58067 (Drug), Standard of Care Therapy (Drug)
Eligibility criteria+524 characters
[...] rement for central MTAP deficiency testing Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whowhose diseases have previouslyprogressed receivedor recurred after receiving standard systemic therapy or radiotherapy, or for whom treatmentstandard systemic therapy is not available or nottolerated, toleratedor would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard treatment in the opinion of the investigator Adequate organ function Exclusion Criteria: Prior treatment with any methylthioadenosine [...] [...]
Secondary endpoints14 entries, revised
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-58067 Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BGB-58067 Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-58067 Phase 1a and 1b: Apparent oral clearance (CL/F) for BGB-58067 Phase 1a and 1b: Half-life (t1/2) of BGB-58067 Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-58067 Phase 1a and 1b: Apparent volume of distribution (Vz/F) for BGB-58067 Phase 1a and 1b: Accumulation ratio (AR) for BGB-58067 Phase 1a and 1b: plasmaPlasma concentrations of BGB [...]
Primary endpoints5 to 6 entries
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 Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteria 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 Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy
Study description+71 characters
[...] ticancer drug called BGB-58067 is. This drug will be tested asalone, monotherapyin combination with BG-89894, and in combination with standard of care therapy in participants with advanced solid tumors and with MTAP deficiency.
Study sites45 entries, revised
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health
Study title+60 characters
An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
2025-06-04
Study Status, Contacts/Locations v10
Study sitesdetails revised at 3 of 45 sites
2025-04-30
Study Status, Contacts/Locations v9
Study sites37→45
2025-04-10
Study Status, Contacts/Locations v8
Study sites32→37
2025-03-20
Study Status, Contacts/Locations v7
Study sitesdetails revised at 3 of 32 sites
2025-03-07
Study Status, Contacts/Locations v6
Study sites30→32
2025-02-14
Study Status, Contacts/Locations, IPDSharing v5
Study sitesdetails revised at 4 of 30 sites
2025-01-31
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 30 sites
2025-01-09
Study Status, Contacts/Locations v3
Study sitesdetails revised at 6 of 30 sites
2024-12-02
Study Identification, Study Status, Contacts/Locations v2
Study sites1→30
2024-11-07
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10→confirmed 2024-10-11
Study sites0→1
Eligibility criteriarevised
[...] Known HIV infection High cardiovascular risk factors QTcF > 450470 ms based on the screening triplicate 12-lead ECG records To [...]
2024-09-06
Original filing
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.
Trial Details
NCT Number NCT06589596
Lead Sponsor BeOne Medicines
Conditions Advanced Solid Tumor
Enrollment 525 participants
Start Date 2025-01-10
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-14