225Ac-ABD147 for Lung Cancer

Recruiting at 3 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

Trial Summary

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.

What makes the drug 225Ac-ABD147 unique for treating lung cancer?

The drug 225Ac-ABD147 is unique because it involves a novel approach using a radioactive isotope, Actinium-225, which targets cancer cells more precisely compared to traditional chemotherapy. This targeted approach may potentially reduce damage to healthy cells and improve treatment outcomes for lung cancer patients. ^{1 2 3 4 5}

What is the purpose of this trial?

The study has 2 parts, Phase 1a and Phase 1b. 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 (SCLC) and large cell neuroendocrine carcinoma (LCNEC) of the lung following platinum-based chemotherapy. An initial group of patients will also be given an experimental imaging agent called 111In-ABD147 to help understand where ABD147 goes in the body. The goal of Phase 1b is to gather additional safety and efficacy data on 225Ac-ABD147 to determine the best dose and to understand how those doses affect the same types of patients' cancers explored enrolled in Phase 1a.

Research Team

Guanying Wang, MD, MS

Principal Investigator

Abdera Therapeutics Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy for non-small cell lung cancer: contribution of the International Adjuvant Lung Trial. [2022]

2. England 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. [2022]

3. China pubmed.ncbi.nlm.nih.gov

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

4. Czech Republic pubmed.ncbi.nlm.nih.gov

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

5. Australia pubmed.ncbi.nlm.nih.gov

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