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MGC018

Phase 2

Extensive-stage Small-cell Lung Cancer | Small molecule | Oncology |MacroGenics, Inc.|Last Updated: Apr 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06227546MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung CancerPHASE2 ACTIVE NOT_RECRUITING 9Apr 15, 2024May 1, 2026Apr 13, 20261 United States
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR)
1 year

Investigator-Assessed ORR per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions as assessed by CT or magnetic resonance imaging (MRI) scans (with IV contrast unless contraindicated) of the chest, abdomen, and pelvis every 2 cycles (each cycle is a 28 day cycle). Reported as the number of patients with a complete response (CR) or partial response (PR); ORR = CR+PR; CR = Disappearance of all target lesions.Any pathological lymph nodes (whether target ornon-target) must have reduction in short axis to\<10 mm. PR= At least a 30% decrease in the sum ofdiameters of target lesions, taking as reference the baseline sum diameters.

Secondary Endpoints
Incidence of Adverse Events
from start of treatment through 60 days after last treatment, approximately 1 year
Duration of Response (DOR)
1 year
Progression-free Survival (PFS) Median
1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MCG018EXPERIMENTAL -
Interventions
NameTypeDescription
MGC018DRUGIntravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age greater than or equal to 18 years at time of signing Informed consent form (ICF) 2. Ability to comply with the study protocol, in the investigator's judgment. 3. Histologically or cytologically confirmed advanced small cell lung cancer that is not amenable to definitive t...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06227546studyFirstPostDate: changed