A Study of MGC028 in Participants With Advanced Solid Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
MacroGenics
Study ID
NCT06723236
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • MGC028 — BIOLOGICAL
    MGC028 is an antibody-drug conjugate targeted against ADAM9.

Study Details

The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9. The main question the study aims to answer is: * What types of side effects will participants experience when receiving MGC028? * Can MGC028 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors? Participants will * Undergo screening procedures to determine eligibility * Receive study treatments initially every 3 weeks. * Have blood samples taken for routine and research tests * Have other examinations to check heart and lung function, and general health status * Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary. * Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.

Key Dates

Start date
Feb 13, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: Cohort 1
    Dose level 1 of MGC028, IV
  • Experimental: Cohort 2
    Dose level 2 of MGC028, IV
  • Experimental: Cohort 3
    Dose level 3 of MGC028, IV
  • Experimental: Cohort 4
    Dose level 4 of MGC028, IV
  • Experimental: Cohort 5
    Dose level 5 of MGC028, IV
  • Experimental: Cohort 6
    Dose level 6 of MGC028, IV
  • Experimental: Expansion Cohort 1
    MTD or MAD of MGC028, IV
  • Experimental: Expansion Cohort 2
    MTD or MAD of MGC028, IV
  • Experimental: Expansion Cohort 3
    MTD or MAD of MGC028, IV

Primary Outcome Measure

Number and Types of Adverse Events (AEs) in Participants Receiving MGC028 [ Time Frame: Throughout the study treatment and safety follow up period, up to 25 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
UCSF - Helen Diller Family Cancer CenterSan FranciscoCalifornia94115
Pamela Munster (PRINCIPAL_INVESTIGATOR)
Dana Farber/Harvard Cancer CenterBostonMassachusetts02115
Kimberly Perez (PRINCIPAL_INVESTIGATOR)
Mass General BrighamBostonMassachusetts02114
Harshaband Singh (PRINCIPAL_INVESTIGATOR)
South Texas Accelerated Research Therapeutics (START) MidwestGrand RapidsMichigan49546
Manish Sharma (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mt. SinaiNew YorkNew York10029
Deborah Doroshow (PRINCIPAL_INVESTIGATOR)
South Texas Accelerated Research Therapeutics (START) San AntonioSan AntonioTexas78229
Drew Rasco (PRINCIPAL_INVESTIGATOR)
South Texas Accelerated Research Therapeutics (START) Mountain RegionWest Valley CityUtah84119
Justin Call (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Colorectal cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
UCSF - Helen Diller Family Cancer Center· San Francisco, CADana Farber/Harvard Cancer Center· Boston, MAMass General Brigham· Boston, MASouth Texas Accelerated Research Therapeutics (START) Midwest· Grand Rapids, MIIcahn School of Medicine at Mt. Sinai· New York, NYSouth Texas Accelerated Research Therapeutics (START) San Antonio· San Antonio, TX

Related Studies