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Monoclonal Antibodies

MCG018 for Small Cell Lung Cancer (MGC018-SCLC Trial)

Phase 2

Recruiting

Led By Chul Kim, MD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed advanced small cell lung cancer that is not amenable to definitive therapy

Availability of pre-treatment tumor tissue via a fresh biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

MGC018-SCLC Trial Summary

This trial is testing a drug called MGC018 in patients with a type of lung cancer called Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) that has come back or is

Who is the study for?

This trial is for people with Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) that has come back or hasn't responded to treatment. Participants will receive MGC018 every 28 days via IV until their disease worsens or the side effects become too much.Check my eligibility

What is being tested?

The study tests if MGC018 can help at least 25% of patients whose ES-SCLC has relapsed or is refractory. It involves regular tumor assessments and blood tests for biomarkers before and during treatment, as well as after disease progression.See study design

What are the potential side effects?

Possible side effects of MGC018 are not specified here but typically may include reactions at the infusion site, fatigue, nausea, and other symptoms depending on how the drug affects the body.

MGC018-SCLC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My small cell lung cancer is advanced and cannot be treated with surgery or radiation meant to cure.

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I can provide a recent biopsy of my tumor.

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I agree to use birth control or remain abstinent.

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I am 18 years old or older.

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My cancer got worse despite platinum-based chemotherapy.

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I can take care of myself and am up and about more than half of my waking hours.

MGC018-SCLC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Duration of response (DOR)

Incidence of Adverse Events

Overall Survival (OS)

+2 more

MGC018-SCLC Trial Design

1Treatment groups

Experimental Treatment

Group I: MCG018Experimental Treatment1 Intervention

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

MacroGenicsIndustry Sponsor

48 Previous Clinical Trials

5,359 Total Patients Enrolled

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,485 Total Patients Enrolled

Chul Kim, MDPrincipal InvestigatorChul.Kim@gunet.georgetown.edu

4 Previous Clinical Trials

53 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"According to the information on clinicaltrials.gov, this particular study is not currently open for enrollment. The trial was initially posted on April 1st, 2024 and last updated on January 18th, 2024. However, there are numerous other trials available that are actively accepting patients at this time - a total of 1532 trials to be precise."

Answered by AI

What is the level of safety observed in patients treated with MCG018?

"Based on our assessment at Power, the safety of MCG018 is rated as 2 on a scale from 1 to 3. This rating reflects the fact that there is available data supporting its safety but no evidence yet regarding its efficacy due to it being in Phase 2 trial stage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer

2024. "MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06227546.