[177Lu]Lu-DFC413 for Breast Cancer

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Disqualifiers: CNS metastases, Low blood counts, others

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

Compensation: Varies

Number of Visits: 2

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called [177Lu]Lu-DFC413, a type of radiopharmaceutical therapy, to determine its safety and effectiveness for individuals with certain advanced or metastatic cancers, such as some breast and lung cancers. Eligible participants should have a type of cancer that has not responded well to other treatments and shows uptake in a specific scan. This trial aims to provide researchers with insights into how the treatment works and its potential benefits for people with difficult-to-treat tumors. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

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

Research shows that \[177Lu\]Lu-DFC413 is still undergoing testing to ensure its safety for people. In current studies, patients receive varying doses of \[177Lu\]Lu-DFC413 to determine safe levels and what the body can handle. Detailed information from human studies is not yet available.

As this is an early-stage study, the main goal is to identify safe dose levels and assess patient tolerance. Researchers closely monitor any side effects to ensure the treatment's safety. If concerns arise, discussing them with the trial team or your doctor might be helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about [177Lu]Lu-DFC413 because it represents a new approach for treating breast cancer using targeted radiotherapy. Unlike traditional chemotherapy or hormone therapy, which can affect both cancerous and healthy cells, [177Lu]Lu-DFC413 is designed to specifically target and deliver radiation directly to cancer cells. This targeted method aims to minimize damage to surrounding healthy tissue, potentially reducing side effects and improving patient outcomes. The use of a radioactive isotope, Lutetium-177, as the active ingredient provides a novel mechanism of action, adding a promising option to the current treatment landscape.

What evidence suggests that [177Lu]Lu-DFC413 might be an effective treatment for breast cancer?

Research shows that \[177Lu\]Lu-DFC413 might help treat breast cancer by delivering radiation directly to tumor cells. In earlier studies, similar treatments using lutetium-177 slowed tumor growth, reducing tumor size by about 3-5% each month. This trial will evaluate \[177Lu\]Lu-DFC413, which could potentially slow down or shrink tumors in patients with solid tumors. Participants will first receive 68Ga-NNS309, and only those with tumor uptake will proceed to receive \[177Lu\]Lu-DFC413. Early results indicate that \[177Lu\]Lu compounds effectively reach and affect cancer cells. Overall, these findings suggest that \[177Lu\]Lu-DFC413 may be a promising option for managing breast cancer. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced solid tumors, including specific types of breast cancer, colorectal cancer (CRC), soft tissue sarcoma, pancreatic ductal adenocarcinoma (PDAC), and non-small cell lung cancer (NSCLC). Participants must have tried other treatments without success or could not tolerate them. Their tumors should also show uptake of a diagnostic agent called 68Ga-NNS309.

Inclusion Criteria

My pancreatic cancer is advanced and hasn't responded to or I can't tolerate standard chemotherapy.

My advanced NSCLC has worsened after chemotherapy and immunotherapy, or I couldn't receive them.

My breast cancer has worsened after hormone therapy and CDK inhibitor treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging

Patients are imaged with a 68Ga-NNS309 PET/CT or PET/MRI scan to evaluate eligibility for 177Lu-DFC413 treatment

1 week

1 visit (in-person)

Treatment - Dose Escalation

Different doses of 177Lu-DFC413 are tested to assess safety, tolerability, and dosimetry

Up to 24 weeks

Multiple visits (in-person)

Treatment - Dose Expansion

Patients receive 177Lu-DFC413 based on tumor type to further evaluate the recommended dose

Up to 24 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 42 months

Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• [177Lu]Lu-DFC413
• 68Ga-NNS309

Trial Overview

The study tests the safety and initial effectiveness of a radioactive drug [177Lu]Lu-DFC413 and examines how well [68Ga]Ga-NNS309 works as an imaging agent in patients with various solid tumors. It's a phase I trial, which means it's early in the testing process to determine appropriate dosages and record any effects.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 2 Interventions

Patients will receive 68Ga-NNS309 and only patients with tumor uptake will receive 177Lu-DFC413

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07261631

Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid ...

The 177Lu-DFC413 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Vz will be ...

2.

novartis.com

novartis.com/clinicaltrials/study/nct07261631

Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid ...

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-DFC413 and safety and imaging properties ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11002837/

Current clinical application of lutetium‑177 in solid tumors ...

The TGR decreased to 3.1% in surface (P=0.016) and 5.0% in volume (P=0.013) per month after treatment. The results suggest that 177Lu-DOTA-TATE can control ...

4.

go.drugbank.com

go.drugbank.com/drugs/DB13982/clinical_trials?conditions=DBCOND0028036%2CDBCOND0028391%2CDBCOND0148150%2CDBCOND0168348%2CDBCOND0034130%2CDBCOND0082002%2CDBCOND0029966%2CDBCOND0068542&phase=1&purpose=treatment&status=recruiting

Lutetium Lu-177 Recruiting Phase 1 Trials for HR+/HER2

Lutetium Lu-177 Recruiting Phase 1 Trials for HR+/HER2- Breast Cancer ... Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors. Lutetium Lu ...

5.

withpower.com

withpower.com/trial/lu-177-for-advanced-breast-cancer-c28c5

Lu-177 for Advanced Breast Cancer (Heroine01 Trial)

The study demonstrated that 177Lu-DOTA-Peptide 2 has a low internalization rate and a high tumor uptake, making it a promising candidate for radionuclide ...

6.

synapse.patsnap.com

synapse.patsnap.com/drug/abb46c42e57c432383475a31351108c6

[177Lu]-DFC413 - Drug Targets, Indications, Patents

A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9605926/

Safety of [177Lu]Lu-NeoB treatment: a preclinical study ...

In general, repeated administration of [ 177 Lu]Lu-NeoB was tolerated. The most significant radiotoxic effects were found in the kidneys.