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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

PHASE1RECRUITING

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, and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Study details:

BGB-58067 is a new drug designed to target a specific protein called protein arginine methyltransferase 5 (PRMT5). This protein is involved in many cell activities and can promote cancer growth when it is overactive. High levels of PRMT5 are linked to poor outcomes in several types of cancer.

This new study will check how safe and helpful a potential anticancer drug called BGB-58067 is. This drug will be tested alone, in combination with BG-89894, and in combination with standard of care therapy in participants with advanced solid tumors and with MTAP deficiency.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Participants must sign the ICF and be capable of giving written informed consent
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70
  3. Life expectancy ≥ 3 months
  4. Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue
  5. Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing
  6. 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
  7. Adequate organ function

Exclusion criteria

  1. Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor
  2. Active leptomeningeal disease or symptomatic spinal cord compression
  3. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
  4. 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
  5. Significantly impaired pulmonary function
  6. Clinically significant infections
  7. Serologically active hepatitis B or C infection
  8. Known HIV infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria
  9. High cardiovascular risk factors
  10. 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)
  11. Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized
  12. Participants who are unable to swallow or with disease/procedure significantly affecting gastrointestinal function
  13. Female participants who are pregnant or are breastfeeding
  14. Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06589596

Intervention or treatment

DRUG: BGB-58067

DRUG: BG-89894

DRUG: Standard of Care Therapy

Conditions

  • Advanced Solid Tumor

  • Condition: Advanced Solid Tumor

  • DRUG: BGB-58067 and other drugs

  • Blacktown, New South Wales, Australia and more

  • Sponsor: BeiGene

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Blacktown Cancer and Haematology Centre

Select from list below to view details:

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, Australia

  • Monash Health

    Clayton, Victoria, Australia

  • Austin Health

    Heidelberg, Victoria, Australia

  • Linear Clinical Research

    Nedlands, Western Australia, Australia

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Who is running the clinical trial?

B

BeiGene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety Expansion
  • Sequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.
Drug: BGB-58067
    EXPERIMENTAL: Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation
    • 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
      EXPERIMENTAL: Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation
      • 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
        EXPERIMENTAL: Phase 1b: Dose Expansion and Optimization
        • 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

          What is the study measuring?

          Primary Outcome

          MeasureDescriptionTime Frame
          Phase 1a: Number of Participants with Adverse Events and Serious Adverse EventsNumber 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) criteriaNot SpecifiedFrom 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 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 therapyMTD 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.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 therapyRDFE 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.Approximately 13 months
          Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapyRP2D established from Phase 1a for BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy for administration in selected tumor types.Approximately 2 years
          Phase 1b: Objective Response Rate (ORR)ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), as assessed by the investigator.Approximately 2 years

          Secondary Outcome

          MeasureDescriptionTime 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-58067Not SpecifiedApproximately 2 months
          Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BGB-58067Not SpecifiedApproximately 9 months
          Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-58067Not SpecifiedApproximately 2 months
          Phase 1a and 1b: Apparent oral clearance (CL/F) for BGB-58067Not SpecifiedApproximately 2 months
          Phase 1a and 1b: Half-life (t1/2) of BGB-58067Not SpecifiedApproximately 2 months
          Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-58067Not SpecifiedApproximately 2 months
          Phase 1a and 1b: Apparent volume of distribution (Vz/F) for BGB-58067Not SpecifiedApproximately 2 months
          Phase 1a and 1b: Accumulation ratio (AR) for BGB-58067Not SpecifiedApproximately 2 months
          Phase 1a and 1b: Plasma concentrations of BGB-58067Not SpecifiedApproximately 9 months
          Phase 1a and 1b: Duration of Response (DOR)DOR is defined as the time from the first determination of an objective response until first documentation of progression or death, whichever occurs first, as assessed by the investigator.Approximately 2 years
          Phase 1a and 1b: Disease Control Rate (DCR)DCR is defined as the percentage of participants with best overall response of a CR, PR, and stable disease, as assessed by the investigator.Approximately 2 years
          Phase 1b: Number of Participants with AEs and SAEsNumber 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 1b: Progression-Free Survival (PFS)PFS is defined as the time from the date of the first dose of study drug to the date of first documentation of progressive disease assessed by investigator or death, whichever occurs first, as assessed by the investigator.Approximately 2 years
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          References

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

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