What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly immunotherapies like IMC-F106C, often have side effects such as fatigue, nausea, diarrhea, and skin reactions. More specific to immunotherapies, patients may experience immune-related adverse events, including colitis, pneumonitis, hepatitis, endocrinopathies, and dermatologic toxicities. These side effects occur because immunotherapies activate the immune system, which can sometimes attack normal tissues in addition to cancer cells.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of solid tumors, particularly those that involve immune checkpoint inhibitors and monoclonal antibodies. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are notable examples, both of which target the PD-1/PD-L1 pathway to enhance the immune system's ability to fight cancer. Additionally, ipilimumab (Yervoy), which targets CTLA-4, has been approved for melanoma. These treatments are similar to IMC-F106C in that they mobilize the immune system to target cancer cells, although IMC-F106C specifically targets the PRAME antigen.

What other types of research exist?

Promising alternatives to IMC-F106C for solid tumor patients include Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2, which has shown efficacy in metastatic small cell lung cancer (mSCLC), and Enfortumab Vedotin, another antibody-drug conjugate targeting Nectin-4, which has demonstrated effectiveness in advanced urothelial carcinoma. Both therapies have shown significant clinical benefits in their respective trials.

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Monoclonal Antibodies

IMC-F106C Combinations for Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Immunocore Ltd

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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests IMC-F106C, a treatment that helps the immune system target and kill cancer cells in adults with advanced cancers. It guides immune cells to attack cancer cells more effectively.

Who is the study for?

This trial is for adults with solid tumors that have relapsed, are resistant to standard therapy, or can't tolerate it. Participants must test positive for HLA-A*02:01 and PRAME in their tumors and agree to use effective contraception if applicable. They should be able to consent and follow the study's rules but can't join if they have serious heart, lung, autoimmune diseases, transplants, active hepatitis B/C, HIV, significant other cancers or allergies related to the study drugs.

What is being tested?

The trial tests IMC-F106C alone and combined with cancer treatments like atezolizumab (a checkpoint inhibitor), pembrolizumab (another checkpoint inhibitor), chemotherapy or tebentafusp. It aims to see how safe and effective these combinations are against cancers that show a specific antigen called PRAME.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells by mistake which could lead to inflammation in various organs. There might also be typical drug infusion reactions such as fever or chills; fatigue; digestive issues; blood-related problems; increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Brenetafusp and Targeted TherapyExperimental Treatment3 Interventions

Participants receive brenetafusp and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology.

Group II: Brenetafusp and Multimodal TherapyExperimental Treatment1 Intervention

Participants receive brenetafusp, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology.

Group III: Brenetafusp and ChemotherapyExperimental Treatment1 Intervention

Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort.

Group IV: Brenetafusp and Anti-PD(L)1 AgentExperimental Treatment1 Intervention

Participants receive brenetafusp and pembrolizumab.

Group V: Brenetafusp MonotherapyExperimental Treatment1 Intervention

Participants receive brenetafusp.

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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

The most common treatments for solid tumors include immunotherapies such as immune checkpoint inhibitors, CAR-T cell therapies, and immune-mobilizing monoclonal T cell receptors like IMC-F106C. Immune checkpoint inhibitors work by blocking proteins that prevent T cells from attacking cancer cells, thereby enhancing the immune response against tumors. CAR-T cell therapies involve modifying a patient's T cells to express chimeric antigen receptors that specifically target cancer cells. IMC-F106C, an immune-mobilizing monoclonal T cell receptor, targets the PRAME antigen on cancer cells, facilitating their recognition and destruction by the immune system. These treatments are crucial for solid tumor patients as they offer targeted approaches that can potentially improve efficacy and reduce side effects compared to traditional therapies.

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