A Study of MGC026 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
MacroGenics
Study ID
NCT06242470
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MGC026 Dose Escalation — BIOLOGICAL
    Escalating doses of MGC026
  • MGC026 Dose for Expansion — BIOLOGICAL
    MGC026 recommended dose for expansion

Study Details

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.

Key Dates

Start date
Mar 6, 2024
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    MGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks.
  • Experimental: Cohort 2
  • Experimental: Cohort 3
  • Experimental: Cohort 4
  • Experimental: Cohort 5
  • Experimental: Cohort 6
  • Experimental: Expansion cohort 1
  • Experimental: Expansion cohort 2
  • Experimental: Expansion cohort 3
  • Experimental: Expansion cohort 4
  • Experimental: Expansion Cohort 5
  • Experimental: Expansion Cohort 6

Primary Outcome Measure

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. [ Time Frame: Throughout the study, up to 135 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
START MidwestGrand RapidsMichigan49546-
START-New York Long IslandLake SuccessNew York11042-
Providence Cancer InstitutePortlandOregon97213-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Texas Health Science Center at HoustonHoustonTexas77030-
START Mountain RegionWest Valley CityUtah84119-

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By research site
The Angeles Clinic and Research Institute· Los Angeles, CASTART Midwest· Grand Rapids, MISTART-New York Long Island· Lake Success, NYProvidence Cancer Institute· Portland, ORThe University of Texas MD Anderson Cancer Center· Houston, TXUniversity of Texas Health Science Center at Houston· Houston, TX

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