What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, and anti-CTLA-4 therapies), often lead to a range of side effects. These can include immune-related adverse events affecting the skin (rash, pruritus), gastrointestinal tract (diarrhea, colitis), liver (hepatitis), and endocrine system (thyroiditis, adrenal insufficiency). Other frequent side effects are fatigue, fever, and infusion-related reactions. Severe adverse events, though less common, can include pneumonitis, myocarditis, and severe colitis, which may require immunosuppressive treatment.

What prior FDA approvals exist?

The FDA has approved several therapies for the treatment of solid tumors, particularly focusing on immune checkpoint inhibitors and targeted therapies. Pembrolizumab and nivolumab, both anti-PD-1 antibodies, have been approved for multiple solid tumors, including melanoma and non-small cell lung cancer. Ipilimumab, an anti-CTLA-4 antibody, is also approved for melanoma. Bevacizumab, a monoclonal antibody targeting VEGF, is used for colorectal cancer and other solid tumors. Tyrosine kinase inhibitors like pazopanib are approved for soft tissue sarcoma. These treatments share similarities with the investigational therapy IGM-7354, which is being studied for its safety and efficacy in relapsed and/or refractory tumors.

What other types of research exist?

Promising novel alternatives to IGM-7354 for solid tumor patients include: <ol> <li>Nivolumab: Validated for safety and efficacy in advanced non-clear cell renal cell carcinoma (CheckMate 374 study).</li> <li></li> </ol> Pembrolizumab: Demonstrated durable complete response in metastatic melanoma (CheckMate 066 study) and effective in Merkel cell carcinoma (JAVELIN Merkel 200 study). 3. Atezolizumab plus Bevacizumab: Shown efficacy in metastatic renal cell carcinoma (IMmotion151 trial). 4. Cabozantinib: Effective after immune checkpoint blockade in metastatic clear-cell renal cell carcinoma.

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Monoclonal Antibodies

IGM-7354 for Cancer

Phase 1

Waitlist Available

Research Sponsored by IGM Biosciences, Inc.

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 study duration of approximately 29 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, IGM-7354, in patients whose tumors have returned or didn't respond to other treatments. The drug is given through an IV, and researchers will observe its effects on the tumors.

Who is the study for?

Adults over 18 with advanced solid tumors that standard treatments can't cure or aren't tolerated. They must have stopped previous cancer therapies at least 2 weeks before, be in fairly good health (ECOG status of 0 or 1), and agree to tumor biopsies. Those with certain immune conditions, recent major surgeries, untreated brain metastases, or severe allergies to monoclonal antibodies can't join.

What is being tested?

IGM-7354 is being tested for safety and how the body processes it in adults whose cancers haven't responded to other treatments. The trial has two parts: finding the right dose and then seeing its effects on a larger group. Participants will receive IGM-7354 during treatment periods followed by a safety check-up after their last dose.

What are the potential side effects?

Since this is an early-stage trial for IGM-7354, specific side effects are not yet fully known but may include typical reactions related to immune-based therapies such as inflammation in organs, infusion-related reactions, fatigue, allergic responses, and potential impacts on organ function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study duration of approximately 29 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study duration of approximately 29 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and study duration of approximately 29 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD

Secondary study objectives

Anti-drug antibodies (ADAs) of IGM-7354

Area Under the Curve (AUC) of IGM-7354

Clearance (CL) of IGM-7354

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: IGM-7354 Single-Agent Dose Expansion Serial BiopsyExperimental Treatment1 Intervention

IGM-7354 will be administered intravenously as a single agent and patients will undergo pre-treatment and on-treatment biopsies.

Group II: IGM-7354 Single-Agent Dose EscalationExperimental Treatment1 Intervention

IGM-7354 will be administered intravenously as a single agent.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IGM-7354

2023

Completed Phase 1

~20

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but also affects normal cells, leading to side effects. Targeted therapy uses drugs that specifically target molecular pathways crucial for tumor growth and survival, minimizing damage to normal cells. Immunotherapy, such as PD-1/PD-L1 inhibitors, enhances the body's immune system to recognize and destroy cancer cells. This is particularly important for solid tumor patients as immunotherapy can provide a more tailored and potentially less toxic treatment option compared to traditional chemotherapy.

Optimizing the Outcome of Anti-Myeloma Treatment with Daratumumab.