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MGC018

Phase 2

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

Target and mechanism

Molecular targetB7-H3
Target classAntigen
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

MGC018 · 1 trial · 1 indication

Phase 2 1
NCT06227546MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung CancerExtensive-stage Small-cell Lung Cancer
ACTIVE NOT_RECRUITING9 Analytics
PHASE2ACTIVE NOT_RECRUITING
MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer
Extensive-stage Small-cell Lung CancerUnlock trial analytics

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 to 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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Frequently asked questions about MGC018

What is MGC018 used for in extensive-stage small-cell lung cancer?

MGC018 is an investigational small molecule being studied for the treatment of extensive-stage small-cell lung cancer. It is currently in Phase 2 clinical development for patients with relapsed or refractory disease. The drug is being evaluated in a single-arm, uncontrolled trial in the United States.

What does MGC018 target?

MGC018 targets B7-H3, an antigen that is expressed on the surface of tumor cells. By binding to B7-H3, the drug is designed to deliver a cytotoxic payload to cancer cells. This mechanism is being investigated in the context of extensive-stage small-cell lung cancer.

Who makes MGC018?

MGC018 is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol MGNX. The company is conducting a Phase 2 clinical trial of MGC018 in patients with relapsed or refractory extensive-stage small-cell lung cancer.

What phase is MGC018 in?

MGC018 is currently in Phase 2 clinical development. It is being studied as an investigational therapy for extensive-stage small-cell lung cancer and has not been approved by regulatory authorities. The ongoing trial is active but not recruiting participants.

What clinical trials is MGC018 in?

MGC018 is being evaluated in a Phase 2 clinical trial with the identifier NCT06227546. The trial is titled 'MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer' and is being conducted in the United States. It has enrolled 9 participants and is active but not recruiting.