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

Trial Summary

What is the purpose of this trial?

GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies.

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.

What safety data exists for GIM-122 in humans?

Imatinib, which may be related to GIM-122, has been used to treat certain cancers and is generally well tolerated, with common side effects like muscle pain, cramps, and mild stomach issues. Serious side effects are rare and usually occur early in treatment. ^{1 2 3 4 5}

Research Team

Omid Hamid

Principal Investigator

The Angeles Clinic and Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

A benefit-risk assessment of imatinib in chronic myeloid leukaemia and gastrointestinal stromal tumours. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Gastrointestinal perforation associated with novel antineoplastic agents: A real-world study based on the FDA Adverse Event Reporting System. [2023]

3. England 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. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

A Case of Disseminated Intra-abdominal Gastrointestinal Stromal Tumor Managed with Low Dose Imatinib. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Severe Gastrointestinal Toxicity Following the Use of Gilteritinib: A Case Series and Analysis of Postmarketing Surveillance Data. [2023]