What is the mechanism of action of this treatment?

The most common treatments for solid tumors often involve immunotherapy, which leverages the body's immune system to target and destroy cancer cells. Agents like IMC-C103C, an immune mobilizing monoclonal T cell receptor against cancer targeting MAGE-A4, work by recognizing specific tumor-associated antigens and activating T cells to attack the cancer. This approach is significant for solid tumor patients as it offers a targeted treatment option that can potentially improve efficacy and reduce side effects compared to traditional therapies. Additionally, combining immunotherapy with other treatments, such as checkpoint inhibitors, can enhance the immune response and improve patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly immune checkpoint inhibitors and other immunotherapies like IMC-C103C, often lead to immune-related adverse events (irAEs). These include skin reactions (rash, pruritus), gastrointestinal issues (diarrhea, colitis), endocrine disorders (thyroid dysfunction), and pulmonary complications (pneumonitis). Severe irAEs may necessitate immunosuppressive therapy. Other frequently reported side effects are infusion-related reactions and fatigue.

What prior FDA approvals exist?

The FDA has approved several immune-based therapies for the treatment of solid tumors. Notably, pembrolizumab and nivolumab, both PD-1 inhibitors, have been approved for various cancers including melanoma and renal cell carcinoma. Ipilimumab, a CTLA-4 inhibitor, is also approved for melanoma. These therapies work by enhancing the body's immune response against cancer cells. Additionally, combination therapies such as nivolumab plus ipilimumab have shown efficacy in treating advanced melanoma. These treatments are similar in approach to IMC-C103C, which targets the MAGE-A4 antigen to mobilize T cells against cancer.

What other types of research exist?

Promising alternatives to IMC-C103C for solid tumor patients include: 1) Pembrolizumab, a PD-1 inhibitor, which has shown efficacy in various solid tumors with high tumor mutational burden (TMB) or mismatch repair deficiency (dMMR). 2) Atezolizumab, a PD-L1 inhibitor, often used in combination with other agents like bevacizumab for enhanced efficacy in cancers such as renal cell carcinoma. 3) Nivolumab, another PD-1 inhibitor, which has demonstrated improved relapse-free survival in melanoma patients. 4) Combination therapies like atezolizumab with cobimetinib, which have shown promise in early-phase trials for colorectal cancer. These therapies are likely to be viable options for solid tumor patients in 2024.

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Checkpoint Inhibitor

IMC-C103C + Atezolizumab for Solid Tumors

Phase 1 & 2

Waitlist Available

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 from first dose to 30 days after the last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial tests IMC-C103C, a treatment that helps the immune system fight cancer, in adults with specific cancer markers. It guides immune cells to attack cancer cells.

Who is the study for?

This trial is for adults with certain advanced solid tumors that are positive for MAGE-A4 and have the HLA-A2 tissue marker. Participants should be relatively fit (ECOG PS 0 or 1), have measurable disease, and must not be responding to standard treatments. They need to use effective contraception if applicable, and cannot join if they're pregnant, breastfeeding, have active infections requiring antibiotics, HIV/HBV/HCV, are on immunosuppressants, or have serious heart issues.

What is being tested?

The trial is testing IMC-C103C alone and combined with Atezolizumab in patients whose cancer cells express a specific protein called MAGE-A4. It's designed to see how safe these treatments are and how well they work against such cancers. This is the first time humans will receive IMC-C103C.

What are the potential side effects?

Potential side effects may include immune-related reactions due to activation of T-cells by IMC-C103C which could affect normal tissues/organs. Atezolizumab can cause similar immune responses as well as fatigue, nausea, fever among others; however individual experiences may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose to 30 days after the last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose to 30 days after the last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to 30 days after the last dose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1: changes in electrocardiogram parameters

Phase 1: changes in laboratory parameters

Phase 1: changes in vital signs

Secondary study objectives

Phase 2: changes in electrocardiogram parameters

Phase 2: changes in laboratory parameters

Phase 2: changes in vital signs

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: IMC-C103C monotherapy SC dose escalationExperimental Treatment1 Intervention

Patients will be enrolled n=9-12 to establish the MTD/expansion dose

Group II: IMC-C103C and atezolizumab dose escalationExperimental Treatment2 Interventions

n=approximately 12 patients to establish the MTD/expansion dose

Group III: IMC-C103C - expansionExperimental Treatment1 Intervention

Patients will be enrolled n=9-24 per expansion cohort (up to 4 total): metastatic/unresectable tumors of interest patients treated at the expansion dose of IMC-C103C to assess preliminary anti-tumor efficacy

Group IV: IMC-C103C - Monotherapy IV dose escalationExperimental Treatment1 Intervention

n= approximately 50 patients to establish the MTD/expansion dose

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

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

The most common treatments for solid tumors often involve immunotherapy, which leverages the body's immune system to target and destroy cancer cells. Agents like IMC-C103C, an immune mobilizing monoclonal T cell receptor against cancer targeting MAGE-A4, work by recognizing specific tumor-associated antigens and activating T cells to attack the cancer. This approach is significant for solid tumor patients as it offers a targeted treatment option that can potentially improve efficacy and reduce side effects compared to traditional therapies. Additionally, combining immunotherapy with other treatments, such as checkpoint inhibitors, can enhance the immune response and improve patient outcomes.

Myeloid-Derived Suppressor Cells as a Therapeutic Target for Cancer.Emerging role for novel immunotherapy agents in metastatic renal cell carcinoma: from bench to bedside.