225Ac-ABD147 for Lung Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Abdera Therapeutics Inc.

Must not be taking: Anticancer therapy, Immunotherapy

Disqualifiers: Myocardial infarction, Cardiac disease, Infection, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

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}

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

I am 18 years old or older.

Expected life expectancy of >12 weeks per the Investigator

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.

Trial 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 (Radioisotope Therapy)

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Cancer Center New York, NY

United Theranostics Glen Burnie, MD

Hoag Memorial Hospital Presbyterian Newport Beach, CA

Who Is Running the Clinical Trial?

Abdera Therapeutics Inc. Lead Sponsor

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] The recently reported International Adjuvant Lung Cancer Trial (IALT) was designed to assess the potential benefit of three to four cycles of adjuvant cisplatin-based chemotherapy after complete resection of non-small cell lung cancer (NSCLC). Each center predetermined the cisplatin dose (total 300-400 mg/m(2)), the combined drug (etoposide or a Vinca alkaloid), and the radiotherapy policy. From 1995 to 2000, 1,867 patients were randomized in 148 centers from 33 countries. On September 1, 2002, median follow-up was 56 months and >98% of patients had an updated follow-up. Overall survival was significantly different between the two arms: 5-year survival rate was 44.5% in the chemotherapy arm versus 40.4% in the control arm [relative risk = 0.86 (0.76-0.98), P

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] Lung cancer represents the major cause of cancer-related death in Europe and North America, accounting for 28% of all cancer deaths. Seventy to 80% of all lung cancers are non-small cell lung cancers (NSCLCs), and approximately 75 % of these patients present with locally advanced or disseminated disease. Even though chemotherapy is now recommended in the majority of cases of unresectable NSCLC, it still fails to substantially modify the fate of these patients. In recent years, several active cytotoxic drugs (paclitaxel, docetaxel, vinorelbine, gemcitabine, and irinotecan) have been developed, showing an overall response rate (ORR)

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

Adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. [2022] Adjuvant chemotherapy has been established as a standard for patients with completely resected non-small cell lung cancer (NSCLC). Adjuvant chemotherapy increased the 5-year survival rates by 4% to 15% within randomized trials and, based on a meta-analysis of five cisplatin-based trials, by 5.4%. Adjuvant chemotherapy consists of a cisplatin-based doublet, preferentially cisplatin plus vinorelbine. Future improvements in outcome of adjuvant therapy are expected by customized chemotherapy and the integration of targeted therapies or immunotherapy.

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

[Contemporary trends of the adjutant chemotherapy in non-small cell lung cancer]. [2022] Adjuvant chemotherapy became a standard of treatment in completely resected non-small cell lung cancer (NSCLC) based on results of big trials meta-analyses, which proved its influence on the decrease of relative mortality risk and absolute improvement of survival. Adjuvant chemotherapy is routinely used according to tumor stage evaluation, performance status (PS) and age of the patients. It is indicated in stage II and IIIA of NSCLC- in frame of clinical studies also in stage IB, in PS 0-1 and in patients under 75 years. Therapy with cisplatin and vinorelbine is a preferred regimen, as well as other drugs, such as paclitaxel, docetaxel, gemcitabine and pemetrexed. The problem is a relatively small dose intensity applied, due to toxic side effects.

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

Management of non-small cell lung cancer according to staging--an update. [2019] The treatment of non-small cell lung cancer (NSCLC) depends on staging based on tumour (T), nodal (N) and metastasis (M) descriptors. Stages I and II tumours are potentially curable with surgery alone. Stage IIIA T3 tumours are also potentially operable. Preoperative chemotherapy appears promising in downstaging stage IIIA disease to enable surgical resection. Recent meta-analyses did not support the use of postoperative chemotherapy for stages I, II and IIIA diseases, but were supportive of the use of cisplatin-based chemotherapy in stage IIIA N2 disease (+ radiotherapy), stage IIIB disease (+ radiotherapy) and in metastatic stage IV disease in improving survival. New chemotherapy agents available over the past few years would further improve the efficacy of chemotherapy in NSCLC.