225Ac-ABD147 for Lung Cancer

Recruiting at 4 trial locations

Overseen By Abdera Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Abdera Therapeutics Inc.

Must not be taking: Anticancer therapy, Immunotherapy

Disqualifiers: Myocardial infarction, Cardiac disease, Infection, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, 225Ac-ABD147, for individuals with small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) of the lung. The researchers aim to determine the treatment's safety, effectiveness, and optimal dose following standard platinum-based chemotherapy. Participants will also receive an imaging agent to track the treatment's distribution in the body. Ideal candidates have completed chemotherapy for advanced or metastatic SCLC or LCNEC and have stable brain metastases (cancer that has spread to the brain but isn't currently causing symptoms). As a 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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used anticancer therapy, radiotherapy, or immunotherapy within 3 weeks before starting the trial.

Is there any evidence suggesting that 225Ac-ABD147 is likely to be safe for humans?

Research has shown that 225Ac-ABD147 has been well-tolerated by patients so far. No reactions have been reported during infusion, a common concern with new treatments. Studies indicate that the treatment targets tumors effectively and exits the bloodstream and vital organs quickly. This suggests it might have fewer side effects compared to other treatments. However, as it remains in early testing, researchers are primarily focused on determining the optimal dose and understanding any potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about 225Ac-ABD147 for lung cancer because it introduces a novel approach using targeted alpha therapy. Unlike traditional treatments such as chemotherapy, radiation, or immunotherapy, which can affect both cancerous and healthy cells, 225Ac-ABD147 utilizes the alpha-emitting isotope Actinium-225. This isotope specifically targets cancer cells while minimizing damage to surrounding healthy tissue, potentially leading to fewer side effects. By delivering potent radioactive particles directly to tumor sites, 225Ac-ABD147 offers a promising new avenue for effectively managing lung cancer.

What evidence suggests that 225Ac-ABD147 might be an effective treatment for lung cancer?

Research has shown that 225Ac-ABD147 yields promising results in early tests. In lab studies, mice with small cell lung cancer (SCLC) experienced significant tumor reduction and increased survival with this treatment. This suggests potential effectiveness for people with similar lung cancer. By targeting a protein on cancer cells, 225Ac-ABD147 may inhibit tumor growth. Although studies in humans are just beginning, with participants receiving 225Ac-ABD147 in either a Phase 1a Dose Escalation Group or a Phase 1b Dose Expansion Group, these early results offer hope for its potential to treat lung cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

Guanying Wang, MD, MS

Principal Investigator

Abdera Therapeutics Inc.

Are You a Good Fit for This Trial?

This trial is for patients with small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) of the lung who have already been treated with platinum-based chemotherapy. Participants should be able to receive radioactive drugs and must not have conditions that could interfere with the study.

Inclusion Criteria

Measurable disease by RECIST v 1.1

Expected life expectancy of >12 weeks per the Investigator

Agree to use contraception or remain abstinent during the study and for a specified period after the last dose of study drug

Exclusion Criteria

Known hypersensitivity to specific substances

Actively enrolled in another clinical study unless observational or follow-up component of an interventional study

My cancer has not been treated yet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Treatment

Participants receive 225Ac-ABD147 in escalating dose cohorts to assess safety, tolerability, and initial efficacy

12 months

Regular visits for dose escalation and monitoring

Phase 1b Treatment

Participants receive the expansion dose of 225Ac-ABD147 to further evaluate safety and efficacy

12 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• 225Ac-ABD147

Trial Overview The trial is testing a new drug called 225Ac-ABD147, aiming to find the best dose for treating SCLC and LCNEC after previous chemotherapy. It includes an initial phase using an imaging agent, 111In-ABD147, to track how ABD147 spreads in the body.

How Is the Trial Designed?

Group I: Phase 1b Dose Expansion Group Experimental Treatment 1 Intervention

Expansion Dose Level selected from Phase 1a Dose Escalation

Group II: Phase 1a Dose Escalation Group Experimental Treatment 1 Intervention

225Ac-ABD147 administered in escalating dose cohorts

225Ac-ABD147 is already approved in United States for the following indications:

Approved in United States as ABD-147 for:

• Small Cell Lung Cancer (SCLC)
• Large Cell Neuroendocrine Carcinoma (LCNEC)

Who Is Running the Clinical Trial?

Abdera Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

70+

Published Research Related to This Trial

Adjuvant chemotherapy significantly reduces mortality risk and improves survival in completely resected non-small cell lung cancer (NSCLC), particularly in patients with stage II and IIIA disease, as supported by large clinical trials.

Current trends in adjuvant therapy focus on personalizing treatment based on patient characteristics and biomarkers, with ongoing studies exploring the use of better-tolerated drugs like carboplatin, targeted therapies, and vaccines to enhance efficacy and reduce side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contemporary trends of the adjutant chemotherapy in non-small cell lung cancer]. Kolek, V.[2022]

Surgery is a potentially curative treatment for non-small cell lung cancer (NSCLC) in stages I and II, and stage IIIA T3 tumors may also be operable with the help of preoperative chemotherapy to downstage the disease.

Postoperative chemotherapy is generally not recommended for stages I, II, and IIIA NSCLC, but cisplatin-based chemotherapy combined with radiotherapy is effective for stage IIIA N2, stage IIIB, and metastatic stage IV NSCLC, improving survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of non-small cell lung cancer according to staging--an update. Lam, WK.[2019]

Lung cancer is the leading cause of cancer-related deaths in Europe and North America, with non-small cell lung cancer (NSCLC) making up 70-80% of cases, and current chemotherapy treatments show limited effectiveness with overall response rates below 20%.

The Southern Italy Cooperative Oncology Group is exploring new triplet chemotherapy combinations involving cisplatin and two additional agents, aiming to improve patient outcomes in advanced NSCLC, with ongoing phase I, II, and III trials evaluating the safety and efficacy of these new treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there any impact of new drugs on the outcome of advanced NSCLC? An overview of the Southern Italy Cooperative Oncology Group trials. Frasci, G., Panza, N., Comella, G., et al.[2022]

The International Adjuvant Lung Cancer Trial (IALT) demonstrated that adjuvant cisplatin-based chemotherapy significantly improves overall survival in patients with resected non-small cell lung cancer (NSCLC), with a 5-year survival rate of 44.5% compared to 40.4% in the control group.

The study involved 1,867 patients across 148 centers and showed that chemotherapy also improved disease-free survival and reduced local recurrence and distant metastases, establishing cisplatin-based chemotherapy as a standard treatment for operable NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy for non-small cell lung cancer: contribution of the International Adjuvant Lung Trial. Dunant, A., Pignon, JP., Le Chevalier, T.[2022]

Adjuvant chemotherapy, particularly with a cisplatin-based doublet like cisplatin plus vinorelbine, has been shown to improve 5-year survival rates for patients with completely resected non-small cell lung cancer (NSCLC) by 4% to 15% in randomized trials.

Future advancements in adjuvant therapy outcomes are anticipated through personalized chemotherapy approaches and the incorporation of targeted therapies or immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. Pirker, R.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06736418

NCT06736418 | Study of 225Ac-ABD147 to Establish ... The goal of Phase 1a is to gather safety, PK and initial efficacy data for 225Ac-ABD147 to better understand best doses for patients with small cell lung cancer ...

2. abderatx.com abderatx.com/wp-content/uploads/2025/04/ABD147-TIP_04022025_submission.pdf

225Ac-ABD147 and DLL3 Preclinical in vivo studies with 225Ac-ABD147 have demonstrated significant anti-tumor efficacy and improved survival in SCLC xenograft models(4). Study ...

3. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT107/761764/Abstract-CT107-A-phase-1a-b-open-label-dose

Abstract CT107: A phase 1a/b, open-label, dose-escalation ... Abstract CT107: A phase 1a/b, open-label, dose-escalation study of 225Ac-ABD147 for locally advanced or metastatic small cell lung cancer and ...

4. mskcc.org mskcc.org/cancer-care/clinical-trials/24-339

A Phase 1 Study of 225Ac-ABD147 in People With Lung ... Researchers want to find the best dose of 225Ac-ABD147 to treat advanced lung cancer. The people in this study have small cell lung cancer (SCLC) or large cell ...

5. withpower.com withpower.com/trial/225ac-abd147-for-lung-cancer-338a4

225Ac-ABD147 for Lung Cancer The goal of Phase 1a is to gather safety, PK and initial efficacy data for 225Ac-ABD147 to better understand best doses for patients with small cell lung cancer ...

6. abderatx.com abderatx.com/press-releases/abdera-therapeutics-presents-initial-phase-1-clinical-data-on-abd-147-a-next-generation-dll3-targeting-radiopharmaceutical-therapy-at-iaslc-2025-world-conference-on-lung-cancer/

Abdera Therapeutics Presents Initial Phase 1 Clinical Data ... Safety: ABD-147 has been tolerated, with no infusion ... Fifteen percent of all lung cancer cases are high-grade neuroendocrine cancers.

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/abdera-trial-radiopharmaceutical-therapy/

Abdera reports initial data from trial of radiopharmaceutical ... The therapy is said to have shown favourable tumour uptake and quick elimination from the bloodstream and critical organs. ... The therapy secured ...

8. finance.yahoo.com finance.yahoo.com/news/abdera-reports-initial-data-phase-093707965.html

Abdera reports initial data from Phase Ia trial of ... The therapy is said to have shown favourable tumour uptake and quick elimination from the bloodstream and critical organs.