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Monoclonal Antibodies

Cohort 1 for Stomach Cancer

Phase 1

Recruiting

Research Sponsored by MacroGenics

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of every 21-day cycle, throughout the study, average of 1 year.

Awards & highlights

Study Summary

"This trial aims to test the safety, effectiveness, and potential anti-cancer effects of MGC026 in individuals with advanced solid tumors. Participants will receive MGC026 through intravenous infusion and may undergo

Who is the study for?

Adults over 18 with advanced solid tumors that can't be removed by surgery, including various cancers like lung, prostate, bladder, and more. They must measure their disease progress using RECIST v1.1 criteria and agree to use effective birth control methods. Pregnant or breastfeeding individuals cannot participate.Check my eligibility

What is being tested?

The trial is testing MGC026's safety and effectiveness against different advanced solid tumors. Participants will receive up to 35 IV infusions of MGC026 in increasing doses until side effects become severe or the cancer worsens.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be closely monitored for any adverse reactions to MGC026 during treatment and through blood tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of every 21-day cycle, throughout the study, average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of every 21-day cycle, throughout the study, average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of every 21-day cycle, throughout the study, average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants with adverse events (AEs) and serious AEs (SAEs)

Secondary outcome measures

DoR in mCRPC

Duration of response (DoR) in advanced solid tumors

Mean (SD) of MGC026 area under the time concentration curve (AUC)

+4 more

Trial Design

10Treatment groups

Experimental Treatment

Group I: Expansion cohort 4Experimental Treatment1 Intervention

Group II: Expansion cohort 3Experimental Treatment1 Intervention

Group III: Expansion cohort 2Experimental Treatment1 Intervention

Group IV: Expansion cohort 1Experimental Treatment1 Intervention

Group V: Cohort 6Experimental Treatment1 Intervention

Group VI: Cohort 5Experimental Treatment1 Intervention

Group VII: Cohort 4Experimental Treatment1 Intervention

Group VIII: Cohort 3Experimental Treatment1 Intervention

Group IX: Cohort 2Experimental Treatment1 Intervention

Group X: Cohort 1Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor

48 Previous Clinical Trials

5,146 Total Patients Enrolled

Denise Casey, MDStudy DirectorMacroGenics

1 Previous Clinical Trials

162 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 patients currently being accepted to participate in this clinical trial?

"As per clinicaltrials.gov, this investigation is actively enrolling subjects. The trial was initially shared on March 6th, 2024 and most recently revised on March 13th, 2024."

Answered by AI

What level of risk does Cohort 1 present to individuals?

"Our research team at Power rates the safety of Cohort 1 as a grade 1 on our scale from 1 to 3. This rating is assigned due to the early Phase 1 nature of the trial, signifying scarce data backing both safety and efficacy claims."

Answered by AI

What is the upper limit in terms of patient enrollment for this medical study?

"Affirmative, information sourced from clinicaltrials.gov indicates that this medical trial is actively seeking eligible individuals. The trial was initially posted on March 6th, 2024, and most recently updated on March 13th, 2024. Recruitment aims to enlist 230 participants distributed across two designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of MGC026 in Participants With Advanced Solid Tumors

2024. "A Study of MGC026 in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242470.

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