IMA203 + mRNA-4203 for Skin Cancer and Soft Tissue Sarcoma

Recruiting at 3 trial locations

Overseen By Immatics US, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Immatics US, Inc.

Disqualifiers: Other malignancies, Autoimmune disease, Cardiac conditions, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 1 year

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combining IMA203 (a type of immunotherapy) and mRNA-4203 (an experimental treatment) to determine its safety and effectiveness against certain skin cancers and soft tissue tumors that cannot be removed or have spread. It specifically targets individuals with cutaneous melanoma or synovial sarcoma who have already tried other treatments. Those who have been told they cannot have surgery or have seen their disease progress after using specific medications might be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IMA203 has been well-tolerated by patients who have undergone previous treatments, with most participants in earlier studies not experiencing severe side effects. The current trial explores how IMA203 works with mRNA-4203. Although this combination is new, the trial phase primarily focuses on ensuring safety for participants. Researchers typically start with lower doses and closely monitor for any reactions. While there is no clear data yet from this combination, the goal remains to ensure maximum safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about IMA203 combined with mRNA-4203 for skin cancer and soft tissue sarcoma because it represents a novel approach to treatment. Unlike traditional therapies such as chemotherapy or radiation, IMA203 works by targeting specific tumor antigens, potentially leading to more precise cancer cell destruction. Meanwhile, mRNA-4203 is an innovative mRNA-based therapy that aims to enhance the immune system's ability to fight cancer. This combination could offer a more targeted and effective way to treat these cancers, sparking hope for improved outcomes in patients with metastatic cutaneous melanoma or synovial sarcoma.

What evidence suggests that this trial's treatments could be effective for skin cancer and soft tissue sarcoma?

Research has shown that IMA203 produced promising results in earlier studies. In a trial with patients who had undergone multiple treatments, IMA203 proved safe and showed positive effects against tumors. In this trial, participants will receive a combination of IMA203 with mRNA-4203 to potentially enhance effectiveness. The researchers aim for mRNA-4203 to help the immune system better target cancer cells. While specific results on the combination's effectiveness are still being gathered, each component has shown potential in fighting cancer. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for people with certain types of skin cancer or soft tissue sarcoma that can't be removed by surgery or has spread. They should have tried some treatments already, like a PD-1 inhibitor for melanoma patients. Participants need to be relatively healthy (ECOG 0-1), expect to live more than 5 months, and women must use birth control.

Inclusion Criteria

My doctor expects me to live more than 5 months.

* CM participants who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor * SS participants must have received (or declined) at least one line of treatment (including SoC) and are still in need of further systemic therapy.

I meet other specific requirements for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IMA203 in combination with mRNA-4203 to evaluate safety, tolerability, and anti-tumor activity

up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• IMA203
• mRNA-4203

Trial Overview The trial tests IMA203 combined with mRNA-4203 on participants with advanced melanoma or synovial sarcoma. It aims to see how safe this combo is, what doses work best, and if it helps shrink the tumors.

How Is the Trial Designed?

Group I: IMA203 with mRNA-4203 in participants with metastatic cutaneous melanoma or synovial sarcoma Experimental Treatment 2 Interventions

This is a non-comparative, open-label trial with different cohorts investigating IMA203 in combination with mRNA-4203.

Who Is Running the Clinical Trial?

Immatics US, Inc.

Lead Sponsor

Trials

6

Recruited

1,100+

ModernaTX, Inc.

Industry Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06946225?term=AREA%5BConditionSearch%5D(Synovial%20sarcoma%20OR%20%22sarcoma,%20synovial,%20malignant%22%20OR%20%22%20synovial%20sarcoma%20(disease)%22%20OR%20%22%20Synovialosarcoma%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=2

ACTengine® IMA203 Combined With mRNA-4203 This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203.

2. jitc.bmj.com jitc.bmj.com/content/13/Suppl_2/A671

590 A first-in-human, phase 1 trial of IMA203 PRAME- ... In a phase 1 trial (NCT03686124), IMA203 exhibited favorable tolerability and encouraging anti-tumor activity in heavily pretreated patients ...

3. mskcc.org mskcc.org/cancer-care/clinical-trials/25-223

A Phase 1 Study of IMA203 Cellular Therapy With mRNA- ... Researchers are seeking the best dose of mRNA-4203 to give with a cellular therapy in people with melanoma or sarcoma. The cellular therapy is called IMA203 and ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06946225

ACTengine® IMA203 Combined With mRNA-4203 This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06946225

ACTengine® IMA203 Combined With mRNA-4203 This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203.