177Lu-IM-3050 for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Immunome, Inc.

Disqualifiers: Recent surgery, CNS tumor, others

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

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called 177Lu-IM-3050, a radiopharmaceutical therapy, for people with advanced cancer. The treatment is administered through an IV every six weeks. It targets individuals who have tried other cancer treatments without success or experienced intolerable side effects. Eligible participants must have a solid tumor and have previously attempted at least one standard treatment but continue to face challenges. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Is there any evidence suggesting that 177Lu-IM-3050 is likely to be safe for humans?

Research has shown that treatments like 177Lu-IM-3050, which use 177Lu radioligand therapy, have generally been safe in various studies. For instance, another similar treatment, 177Lu-FAPI-XT, was safe and showed early signs of tumor reduction. This suggests that such treatments are usually well-tolerated. However, because 177Lu-IM-3050 remains in the early testing stages, researchers are still learning about its safety in humans. This study marks one of the first trials of this treatment in people, so complete safety information is not yet available. Participants should be aware that the safety of this treatment is still under investigation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

177Lu-IM-3050 is unique because it uses a radioactive isotope, Lutetium-177, to directly target and destroy cancer cells, which is different from traditional chemotherapy that affects both cancerous and healthy cells. This targeted approach aims to minimize damage to healthy tissues and reduce side effects. Researchers are excited about 177Lu-IM-3050 because it offers a promising new way to treat cancer with potentially greater precision and effectiveness than existing treatments.

What evidence suggests that 177Lu-IM-3050 might be an effective treatment for advanced cancer?

Research has shown that 177Lu-IM-3050 could be a promising treatment for advanced cancer. This trial will investigate 177Lu-IM-3050, which targets a protein called fibroblast activation protein (FAP) found in many cancer cells. In early animal studies, 177Lu-IM-3050 effectively shrank tumors. The active ingredient, Lutetium-177, has succeeded in other cancer treatments, such as those for prostate and stomach cancer. These early results suggest that 177Lu-IM-3050 might offer a new way to treat advanced cancers. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have relapsed or not responded to at least one standard treatment.

During screening, participants must have positive FAP PET/CT uptake as described in criteria for continuation of IM-3050 treatment

Participants must have measurable disease as per RECIST v.1.1 based on imaging performed during Screening

Exclusion Criteria

Participant has received an investigational product or been treated with an investigational device within 30 days, or 5 half-lives prior to receiving the FAP PET/CT imaging tracer or 177Lu-IM-3050

I have received specific types of radiation therapy before, as required by the study.

I have not had another cancer in the past 3 years, except for certain fully removed cancers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating repeated doses of 177Lu-IM-3050 to determine maximum tolerated dose and/or recommended expansion dose

6 weeks per cycle

In-person visits per cycle

Dose Expansion

Further evaluation of safety and tolerability of 177Lu-IM-3050 at the candidate recommended dose

6 weeks per cycle

In-person visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

42-49 days following last dose

What Are the Treatments Tested in This Trial?

Interventions

• 177Lu-IM-3050

How Is the Trial Designed?

Group I: 177Lu-IM-3050 Active Control 1 Intervention

177Lu-IM-3050 administered intravenously on a 6-week cycle

Who Is Running the Clinical Trial?

Immunome, Inc.

Lead Sponsor

Trials

7

Recruited

420+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07505771

NCT07505771 | A Phase 1 Study of 177Lu-IM-3050 in ...

... effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer. Detailed Description. IM-3050-101 is a 2-part Phase 1 first-in-human (FIH) ...

2.

investors.immunome.com

investors.immunome.com/immunome-to-present-preclinical-data-for-im-3050-its-lead-radioligand-therapy-candidate-at-2024-american-association-for-cancer-research-aacr-annual-meeting/

Immunome to Present Preclinical Data for IM-3050, Its ...

It will present preclinical data for IM-3050, the company's lead lutetium-177 radioligand therapy (RLT) targeting fibroblast activation protein (FAP).

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41204752/

Systematic review and meta-analysis of the efficacy and ...

Overall, these findings suggest that the efficacy and safety of [177Lu]Lu-edotreotide are in line with those reported for other RPTs in similar ...

4.

delta.larvol.com

delta.larvol.com/Products/?ProductId=dc84bb54-3c46-4f00-982a-e85e5f2340e2

IM-3050 / Immunome

A novel lutetium-177 radioligand therapy targeting FAP has potent antitumor activity in xenograft cancer model (AACR 2024) - "Screening this library for ...

5.

htsyndication.com

htsyndication.com/us-fed-news/article/clinical-trial%3A-a-phase-1-study-of-177lu-im-3050-in-participants-with-advanced-cancer/555823435

Clinical Trial: A Phase 1 Study of 177Lu-IM-3050 in ...

Brief Summary: IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced ...

6.

synapse.patsnap.com

synapse.patsnap.com/drug/c11278731cc94509ae759a3a21ef010c

IM-3050 - Drug Targets, Indications, Patents

Varegacestat was generally well tolerated with a manageable safety profile, consistent with the gamma secretase inhibitor class. Immunome plans to share ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12860811/

Safety and efficacy of 177Lu-FAPI-XT radioligand therapy in ...

Lu-FAPI-XT demonstrated a favorable safety profile, with preliminary signs of tumor response observed. ... Efficacy and safety evaluation of 177Lu ...

8.

dev-multi-sponsor-trials.xogene.com

dev-multi-sponsor-trials.xogene.com/trials/7505771

A Phase 1 Study of 177Lu-IM-3050 in Participants ... - GoodDay

IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.