[225Ac]Ac-ETN029 for Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Low blood counts, QTcF ≥ 470 msec, eGFR < 60, CNS metastases, lung disease, others

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

Compensation: Varies

Number of Visits: Unknown

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called [225Ac]Ac-ETN029 to determine its safety and effectiveness for individuals with certain advanced cancers. The researchers aim to understand how the treatment functions in the body and its potential in fighting cancer. Individuals with cancers that are difficult to remove or have spread, such as small cell lung cancer or specific neuroendocrine cancers, and who have found previous treatments ineffective, might be suitable candidates. Participants will contribute to scientists' understanding of this new treatment option. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

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 treatments similar to [225Ac]Ac compounds are generally safe. For instance, a study on [225Ac]Ac-PSMA, used for prostate cancer, found that most patients tolerated it well without severe side effects.

As [225Ac]Ac-ETN029 is in the early stages of testing, the primary goal is to assess its tolerability. Early trials focus on safety and closely monitor any side effects. Although specific safety information for [225Ac]Ac-ETN029 is not yet available, the success of similar treatments is encouraging. However, each new treatment may present different risks. It is crucial to consult a healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for cancer, which often involve chemotherapy or radiation, [225Ac]Ac-ETN029 is a novel radiopharmaceutical that delivers targeted alpha therapy directly to cancer cells. This treatment uses the active ingredient Actinium-225, which emits powerful alpha particles that can destroy cancer cells with minimal damage to surrounding healthy tissue. Researchers are excited about [225Ac]Ac-ETN029 because it offers a new mechanism of action by precisely targeting cancer cells, potentially leading to more effective outcomes with fewer side effects. Additionally, some patients in the trial receive 111In-ETN029, which helps track the treatment's distribution and effectiveness in the body, further enhancing its precision and potential success.

What evidence suggests that [225Ac]Ac-ETN029 might be an effective treatment for cancer?

Research has shown that [225Ac]Ac-ETN029, which participants in this trial may receive, may help treat certain cancers. In lab tests, a single dose of this treatment significantly shrank tumors and extended subjects' lifespans. This effect was particularly notable in cancers with a protein called DLL3, present in some tumors. Although information from human participants is still being gathered, similar treatments using actinium-225 have proven effective for other advanced cancers. This suggests that [225Ac]Ac-ETN029 might also be effective for cancers with DLL3. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancers that express DLL3, such as certain lung, pancreatic, prostate, and neuroendocrine carcinomas. Participants must have progressed after standard treatments or be intolerant to them. They need at least one measurable tumor lesion that absorbs a specific diagnostic agent seen on scans.

Inclusion Criteria

I have advanced prostate cancer with specific markers and at least one tumor visible on scans.

I have GEP-NEC that's worsened after treatment, and a lesion that absorbs a specific diagnostic agent more than surrounding tissues.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of 225Ac-ETN029 to determine the recommended dose for further evaluation

Approximately 24 weeks

Dose Expansion

Further characterization of safety, tolerability, and preliminary anti-tumor activity of 225Ac-ETN029 at the recommended dose

Approximately 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 42 months

What Are the Treatments Tested in This Trial?

Interventions

• [111In]In-ETN029
• [225Ac]Ac-ETN029

Trial Overview [225Ac]Ac-ETN029 and [111In]In-ETN029 are being tested for safety and effectiveness in treating DLL3-positive cancers. The study will first determine the right dose of these agents (dose escalation) and then assess their impact on a larger group of patients (dose expansion).

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 2 Interventions

Patients will receive 225Ac-ETN029, with some patients also receiving 111In-ETN029

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/NCT07006727

NCT07006727 | Phase I Study of [225Ac]Ac-ETN029 in ... The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [225Ac]Ac-ETN029 and the safety and imaging ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2025-07471

Phase I Study of [225Ac]Ac-ETN029 in Patients With ... The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [225Ac]Ac-ETN029 and the safety and imaging ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11816130/

Long-Term Safety and Survival Outcomes of [225Ac]Ac- ... These results emphasize the potential of [225Ac]Ac-PSMA as an effective therapy for advanced prostate cancer, especially regarding long-term ...

4. theranostictrials.org theranostictrials.org/studies/cl74bp9il0261ajjfrm1lc6fe/study/NCT07006727

NCT07006727 The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [225Ac]Ac-ETN029 and the safety and imaging properties ...

5. acs.digitellinc.com acs.digitellinc.com/p/s/etn029-discovery-and-development-of-a-dll3-targeting-radioligand-therapy-for-the-treatment-of-sclc-and-beyond-640249

ETN029: Discovery and development of a DLL3-targeting ... In CDX models (NCI-H69, SHP-77), a single dose of [225Ac]Ac-ETN029 (0.35-1.4 µCi) resulted in robust tumor regression and prolonged survival. These studies ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39941774/

Long-Term Safety and Survival Outcomes of [225Ac]Ac- ... In conclusion, this study demonstrates that [225Ac]Ac-PSMA PRLT, both as monotherapy and combined with [177Lu]Lu-PSMA as TANDEM PRLT, is generally safe in terms ...