GIM-122 for Advanced Solid Cancers

Recruiting at 11 trial locations

Overseen By LumaBridge CRO

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Georgiamune Inc

Must be taking: PD-1 inhibitors

Must not be taking: Systemic steroids

Disqualifiers: Cardiac issues, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

111 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GIM-122 for individuals with advanced solid cancers that have not responded to other treatments. The goal is to determine if GIM-122 is safe and effective when administered through an IV. This trial suits those who have tried FDA-approved treatments like PD-1 or PD-L1 inhibitors for advanced cancer without improvement. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, you cannot participate if you have received systemic anti-cancer therapy or immunosuppressive therapy within 2 weeks before starting the trial, or if you have taken certain other treatments within 4 weeks.

Is there any evidence suggesting that GIM-122 is likely to be safe for humans?

Research shows that GIM-122 is a new treatment being tested for safety in people with advanced cancers. As this is an early-stage study, the main goal is to assess its safety and tolerability. Initial findings indicate that researchers are testing GIM-122 for safety when administered through an IV, meaning directly into the bloodstream.

Since this is the first time GIM-122 is tested in humans, detailed safety data from earlier trials is unavailable. However, researchers closely monitor treatments in these early trials for side effects. The trial's progression suggests some initial confidence in its safety. Participants receive careful monitoring to identify and address any unwanted effects quickly.

While specific data on GIM-122's safety is not yet available, the trial's progress indicates it is considered safe enough for human testing. Participants receive close medical attention to manage any potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

GIM-122 is unique because it offers a novel approach to treating advanced solid cancers through its new mechanism of action. Unlike traditional treatments like chemotherapy, which target rapidly dividing cells indiscriminately, GIM-122 is designed to precisely target specific cancer cell pathways, potentially leading to fewer side effects. Researchers are excited about GIM-122 because it is administered intravenously, allowing for controlled and direct delivery to the bloodstream, which may enhance its effectiveness against hard-to-treat tumors.

What evidence suggests that GIM-122 might be an effective treatment for advanced solid cancers?

Research has shown that GIM-122 could be a promising treatment for advanced solid cancers. This drug is a special type of protein that helps the body's immune system find and attack cancer cells. In early studies, most patients tolerated GIM-122 well, although some experienced serious side effects. This suggests that GIM-122 might help treat cancers by boosting the immune system. The current trial examines its safety and effectiveness in people with advanced tumors. While more research is needed to confirm its effectiveness, these early results are encouraging. ^{1 2 3 6 7}

Who Is on the Research Team?

Omid Hamid

Principal Investigator

The Angeles Clinic and Research Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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.

I have no other treatment options available for my condition.

Exclusion Criteria

I have not received any live vaccines in the last 30 days.

I am not enrolled in another clinical trial or receiving other cancer treatments.

I have cancer at more than one site.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Enrichment (Phase 1)

Participants receive escalating doses of GIM-122 to evaluate safety, tolerability, and determine the maximum tolerated dose (MTD)

18 months

Dose Optimization and Cohort Expansion (Phase 2)

Participants receive the recommended Phase 2 dose (RP2D) of GIM-122 to further evaluate safety, tolerability, and antitumor activity

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

• GIM-122

Trial Overview 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.

How Is the Trial Designed?

Group I: Intravenous administration of GIM-122 Experimental Treatment 1 Intervention

GIM-122

GIM-122 is already approved in United States for the following indications:

Approved in United States as GIM-122 for:

• None approved yet; currently in Phase 1/2 clinical trials for advanced solid malignancies

Who Is Running the Clinical Trial?

Georgiamune Inc

Lead Sponsor

Trials

3

Recruited

310+

Published Research Related to This Trial

A comprehensive analysis of the FDA Adverse Event Reporting System identified 5226 cases of gastrointestinal perforation (GIP) linked to 37 novel antineoplastic drugs, highlighting a significant safety concern associated with these medications.

Out of the 37 drugs analyzed, 22 showed statistically significant signals for GIP, particularly those targeting vascular endothelial growth factor and immune checkpoints, indicating a need for careful monitoring and management of this adverse event in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal perforation associated with novel antineoplastic agents: A real-world study based on the FDA Adverse Event Reporting System. Yu, Z., Zhu, H., Chen, H., et al.[2023]

In a study of 470 Japanese patients with imatinib-resistant or intolerant gastrointestinal stromal tumors, sunitinib demonstrated good efficacy with a 20% objective response rate and a median progression-free survival of 22.4 weeks.

The treatment was generally well-tolerated, with 70% of patients experiencing grade ≥ 3 adverse events, but specific early adverse events like hand-foot syndrome and leukopenia were linked to improved progression-free survival, indicating they may serve as positive prognostic markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, efficacy and prognostic analyses of sunitinib in the post-marketing surveillance study of Japanese patients with gastrointestinal stromal tumor. Komatsu, Y., Ohki, E., Ueno, N., et al.[2022]

Imatinib mesylate is an effective adjuvant therapy for metastatic gastrointestinal stromal tumors (GIST), as demonstrated by the continued decrease in tumor size in a 74-year-old female patient after dose reduction.

The patient experienced severe adverse events from imatinib, including skin rashes and tremors, but these improved significantly after the dosage was lowered, highlighting the importance of dose management in minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of Disseminated Intra-abdominal Gastrointestinal Stromal Tumor Managed with Low Dose Imatinib. Jang, BH., Kim, BW., Lim, KJ., et al.[2017]

Gilteritinib is an effective treatment for adults with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations, showing advantages in survival and a generally favorable safety profile.

While gilteritinib is associated with common side effects like diarrhea and nausea, serious gastrointestinal events such as GI hemorrhage and perforation have been reported, highlighting the need for careful monitoring in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Gastrointestinal Toxicity Following the Use of Gilteritinib: A Case Series and Analysis of Postmarketing Surveillance Data. Gozzo, L., Nardo, A., Brancati, S., et al.[2023]

Imatinib, a tyrosine kinase inhibitor, has significantly improved the prognosis for patients with chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours (GIST), showing high rates of cytogenetic and molecular responses across all phases of CML.

The drug is well tolerated, with only mild adverse effects such as joint pain and gastrointestinal symptoms, primarily occurring in the first two years of treatment, making it a safe and effective oral option for these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A benefit-risk assessment of imatinib in chronic myeloid leukaemia and gastrointestinal stromal tumours. Wolf, D., Rumpold, H.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06028074

NCT06028074 | Safety and Tolerability Study of GIM-122 in ... This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in ...

2. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/GIM122-CT01

GIM-122 as a Single Agent in Advanced Solid Malignancies The purpose of this study is to evaluate an investigational drug called GIM-122 in people who have been diagnosed with an advanced or malignant tumors.

3. masseycancercenter.org masseycancercenter.org/clinical-trials/clinical-trial-details/first-in-human-open-label-phase-12-dose-escalation-with-enrichment-and-dose-expansion-study-to-inves

First In-Human, Open-Label, Phase 1/2 Dose-Escalation ... ... GIM-122 as a Single Agent in Adult Subjects with Advanced Solid Malignancies. Objective. Primary Objective Part A and B To characterize the safety and ...

4. withpower.com withpower.com/trial/phase-2-neoplasms-8-2023-6b4bd

GIM-122 for Advanced Solid Cancers The treatment was generally well-tolerated, with 70% of patients experiencing grade ≥ 3 adverse events, but specific early adverse events like hand-foot ...

5. uclahealth.org uclahealth.org/clinical-trials/safety-and-tolerability-study-gim-122-subjects-with-advanced

Safety and Tolerability Study of GIM-122 in Subjects With ... This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in ...

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06028074

GIM-122 in Subjects With Advanced Solid Malignancies This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in ...

7. masseycancercenter.org masseycancercenter.org/clinical-trials/details/first-inhuman-openlabel-phase-12-doseescalation-with-enrichment-and-doseexpansion-study-to-investiga

First In-Human, Open-Label, Phase 1/2 Dose-Escalation ... ... Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects with Advanced Solid Malignancies.