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Monoclonal Antibodies

GIM-122 for Advanced Solid Cancers

Phase 1 & 2

Recruiting

Led By Omid Hamid, MD

Research Sponsored by Georgiamune Inc

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor

Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of a new drug to treat advanced cancers in adults.

Who is the study for?

This trial is for adults with advanced solid tumors who have tried FDA-approved PD-1 or PD-L1 inhibitors and didn't respond well, are intolerant, or the cancer came back. They must be in good physical condition (ECOG 0-1), not on other trials or immunosuppressive drugs recently, and have no major surgeries or certain treatments close to starting this trial. Pregnant/breastfeeding women can't join.Check my eligibility

What is being tested?

GIM-122, a new type of antibody therapy for cancer, is being tested for safety and effectiveness in patients with advanced solid tumors. It's given through an IV. This early-phase study will also look at how the body processes the drug.See study design

What are the potential side effects?

Possible side effects aren't detailed here but may include typical reactions to monoclonal antibodies such as infusion-related reactions, immune system complications affecting various organs, fatigue, allergic responses and potential blood abnormalities.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced, cannot be surgically removed, or has spread.

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I have tried FDA-approved PD-1 or PD-L1 inhibitors for my cancer and it didn't work or I couldn't tolerate it.

Select...

I have no other treatment options available for my condition.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Anti-tumor activity of GIM-122

Dose limiting toxicities [DLT] with GIM-122

Incidence and severity of AE / SAEs and tolerability

+3 more

Secondary outcome measures

Area under the plasma concentration versus time curve (AUC)

Best overall response (BOR)

Disease control rate (DCR)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intravenous administration of GIM-122Experimental Treatment1 Intervention

GIM-122

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Georgiamune IncLead Sponsor

Omid Hamid, MDPrincipal InvestigatorThe Angeles Clinic and Research Institute

1 Previous Clinical Trials

97 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for this study still open?

"Contrary to expectations, this clinical trial is not currently searching for participants. Initially posted on September 1st 2023 and last updated 8 days later, it appears no new patients are being sought at present. In contrast, 2545 other trials are actively recruiting as of now."

Answered by AI

What is the chief purpose of this experiment's execution?

"This 18-month clinical trial seeks to determine the Maximum Tolerated Dose of GIM-122. In addition, it will assess Peak Plasma Concentration (Cmax), Time of peak plasma concentration (Tmax) and Overall Response Rate (ORR). These metrics are being used to preliminarily evaluate advanced malignant tumors in patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies

2023. "Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028074.