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NCT06242470

A Study of MGC026 in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 4 months later.

See at-risk trials from MacroGenics

Track this trial

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Record History

All 18 versions: 15 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 250 → 394 participants Show 6 more changesShow less
    • Primary completion pushed from May 2028 to Oct 2028
    • Study completion pushed from Oct 2028 to Apr 2029
    • Interventions modified
    • Trial arms changed: 12 → 16
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (9)
  2. Study sites: 11 to 12v16
  3. Primary endpoint revisedv15
  4. Primary endpoint revisedv13 Show 4 more changesShow less
    • Enrollment target: 230 to 250
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints: 7 to 9
    • Study arms: 10 to 12
  5. Study sites: 10 to 11v12
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 9 to 10v10
  2. Study sites: 8 to 9v9
  3. Study sites: 7 to 8v8
  4. Study sites: 6 to 7v7
  5. Study sites: 5 to 6v6
  6. Study sites: 4 to 5v5
  7. Study sites: 3 to 4v4
  8. Study sites: 2 to 3v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 2024 to Mar 6, 2024
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.
Timeframe: Throughout the study, up to 135 weeks

Secondary (9)

Overall response rate in advanced solid tumors
Duration of response (DoR) in advanced solid tumors
ORR rate in metastatic castration resistant prostate cancer (mCRPC)
DoR in mCRPC
Mean (standard deviation [SD]) of vobramitamab tavatecan total and conjugated antibody maximum serum concentration (Cmax)
Show 4 moreShow less
Mean (standard deviation [SD]) of vobramitamab tavatecan unconjugated payload Cmax
Mean (SD) of vobramitamab tavatecan total and conjugated antibody area under the time concentration curve (AUC)
Mean (SD) of vobramitamab tavatecan unconjugated payload AUC
Number of participants who develop anti-vobramitamab tavatecan antibodies (immunogenicity)

Arms and interventions

Module A Cohort 1Experimental

MGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks.

Module A Cohort 2Experimental
Module A Cohort 3Experimental
Module A Cohort 4Experimental
Module A Cohort 5Experimental
Module A Cohort 6Experimental
Module A Expansion cohort 1Experimental
Module A Expansion cohort 2Experimental
Module A Expansion cohort 3Experimental
Module A Expansion cohort 4Experimental
Module A Expansion Cohort 5Experimental
Module A Expansion Cohort 6Experimental
Module A Expansion Cohort 7Experimental
Module A Expansion Cohort 8Experimental
Module B Part 1, Dose Level 1Experimental
Module B Part 1, Dose Level 2Experimental

Module B Part 2, Dose Expansion

Biologicals: MGC026 Dose Escalation, MGC026 Dose for Expansion, Pembrollizumab, vobramitamab tavatecan

Sites

12 sites in 3 countries

United States 7, Australia 3, United Kingdom 2