A Study of MGC030 in Participants With Advanced Solid Tumors

Sponsor
MacroGenics
Study ID
NCT07822399
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • MGC030 — BIOLOGICAL
    Antibody-drug conjugate

Study Details

The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of MGC030. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors of select types. The main question the study aims to answer is: * What types of side effects will participants experience when receiving MGC030? * Can MGC030 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

First listed
Sep 16, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2028
Completion
Mar 31, 2029

Study Design

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

Arms

  • Experimental: Dose escalation Cohort 1
    MGC030 Dose Level 1
  • Experimental: Dose escalation Cohort 2
    MGC030 Dose Level 2
  • Experimental: Dose escalation Cohort 3
    MGC030 Dose Level 3
  • Experimental: Dose escalation Cohort 4
    MGC030 Dose Level 4
  • Experimental: Dose escalation Cohort 5
    MGC030 Dose Level 5
  • Experimental: Dose escalation Cohort 6
    MGC030 Dose Level 6
  • Experimental: Dose Optimization Cohort 1
    Dose Optimization Dose Level 1
  • Experimental: Dose Optimization Cohort 2
    Dose Optimization Dose Level 2
  • Experimental: Expansion Cohort 1
    Recommended dose for expansion
  • Experimental: Expansion Cohort 2
    Recommended dose for expansion
  • Experimental: Expansion Cohort 3
    Recommended dose for expansion
  • Experimental: Expansion Cohort 4
    Recommended dose for expansion
  • Experimental: Expansion Cohort 5
    Recommended dose for expansion

Primary Outcome Measure

Number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to dose interruption, AEs leading to dose reduction or treatment discontinuation, does limiting toxicities and AEs of special interest. [ Time Frame: Throughout the study, estimated duration 2 years. ]

Central Contacts

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