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Small-Cell Lung Cancer (SCLC)Phase 1NCT06736418

Study of 225Ac-ABD147 to Establish Optimal Dose in Patients With SCLC and LCNEC of the Lung That Previously Received Platinum-based Chemotherapy

A Phase 1 study testing 225Ac-ABD147 in people with Small-Cell Lung Cancer (SCLC) and Large Cell Neuroendocrine Carcinoma of the Lung, run by Abdera Therapeutics Inc. at 12 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
225Ac-ABD147
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
12 sitesUnited States
Study dates
10 Mar 2025to Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has confirmed, locally advanced or metastatic SCLC or LCNEC of the lung.
  • Has received platinum-based chemotherapy.
  • Mentally competent and able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study specific evaluation.
  • Age ≥18 years old at the time the ICF is signed.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
  • Expected life expectancy of >12 weeks per the Investigator.
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  • Has disease that is measurable by RECIST v1.1.
  • Patients with known brain metastases are eligible provided they are considered by the Investigator to be neurologically stable and meet the following criteria: a. Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to Cycle 1 Day 1 (C1D1); b. Symptoms are stable and steroid/antiepileptic doses remain unchanged for a minimum of 2 weeks prior to C1D1.
  • At least 4 weeks from prior major surgery (other than for brain metastases), or at least 7 days from prior non-study-related minor surgery prior to C1D1. In all cases, the patient must be sufficiently recovered and stable before the study treatment administration.
  • Willing to provide archival tumor tissue for central analysis; if unavailable, a pre-study treatment biopsy may be collected and provided.
  • Female and male patients of childbearing potential agree to use at least 2 highly effective forms of contraception (1 at least must be barrier method) or agree to completely remain abstinent for duration of study and for 6 months after the last administration of study drug for both female patients and male patients.
  • Patients agree to not make semen/egg donations during treatment, within 2 weeks following the last dose of 111In-ABD147, and for 6 months following the last dose of 225Ac-ABD147.

Who cannot join

  • Was previously treated with 225Ac-ABD147.
  • Has a history of steroid dependent hepatitis caused by treatment with a checkpoint inhibitor.
  • Is actively enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the follow-up component of an interventional study.
  • Use of an anticancer therapy, radiotherapy (external beam radiotherapy [EBRT], brachytherapy, inoperative radiation therapy, radiopharmaceuticals), or immunotherapy within 3 weeks prior to C1D1. Prior treatment with DLL3-targeting agent is acceptable with appropriate washout.
  • Has a medical history of myocardial infarction or unstable angina within 6 months before C1D1.
  • Has clinically significant cardiac disease not controlled by medical therapy (eg, congestive cardiac failure, arrhythmia, coronary heart disease).
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  • Has evidence of active infection requiring intravenous (IV) antibiotics during Screening requiring therapy within 7 days prior to C1D1.
  • Has active uncontrolled bleeding or a bleeding diathesis within 28 days prior to C1D1.
  • Has serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to C1D1.
  • Has received any thoracic radiotherapy within 8 weeks prior to C1D1.
  • Has a history of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis (requiring steroids or immunosuppressive agents), or idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest computed tomography (CT) scan. Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Has known hypersensitivity to Ac-225; for patients participating in the 111In-ABD147 dosimetry substudy, also has known hypersensitivity to In-111.
  • Has known hypersensitivity to Chinese hamster ovary cell products.
  • Has a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • Has human immunodeficiency virus infection; patients who are taking an effective antiviral therapy with undetectable viral load prior to C1D1 are eligible.
  • Has chronic hepatitis B virus (HBV) infection. Patients who are taking an effective suppressive therapy and have an undetectable HBV viral load are eligible.
  • Has a history of hepatitis C virus (HCV) infection, unless treated and cured; patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible.
  • Has carcinomatous meningitis.
  • Has active symptomatic cord compression.
  • Has active symptomatic superior vena cava syndrome.
  • Has another primary malignancy that has not been treated with curative intent (discuss with Medical Monitor), except for non-metastatic cutaneous basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.
  • Is unwilling or unable to follow protocol requirements.
  • Has any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites
  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • United Theranostics

    Glen Burnie, Maryland, 21061

  • MD Anderson

    Houston, Texas, 77030

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Sylvester Comprehensive Cancer Center, Univ of Miami

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of California, San Francisco

    San Francisco, California, 94143

  • University of California, Los Angeles

    Santa Monica, California, 90404

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: A Phase 1a/b, Open-label, Dose-escalation Study of the Safety, Pharmacokinetics, and Initial Efficacy of 225Ac-ABD147 in Patients With Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma of the Lung Following Platinum-based Chemotherapy

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.

Read the detailed description

This is an open-label, Phase 1a/b, first-in-human study to assess the safety profile, tolerability, biodistribution, pharmacokinetics (PK), and preliminary antitumor activity of 225Ac-ABD147 in patients with confirmed locally advanced or metastatic small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) of the lung. All patients must have previously received platinum-based chemotherapy.

Phase 1a will determine the safety, tolerability, dosimetry, PK, and the dose of 225Ac-ABD147 for expansion in the Phase 1b portion.

In addition to receiving treatment, a subset of patients in Phase 1a will undergo either 111In-ABD147-based or 225Ac-ABD147 dosimetry assessments to confirm tumor specificity, identify biodistribution, and to provide insight into dose absorption into tumor and normal tissues.

Phase 1b will evaluate the safety and preliminary efficacy of 225Ac-ABD147 as based on the Phase 1a dose level for expansion by the Safety Review Committee to determine the recommended Phase 2 dose (RP2D).

Being tested
225Ac-ABD147
Keywords
Actinium, Ac-225, 225Ac-ABD147, Indium, In-111, 111In-ABD147, ABD147, Abdera Therapeutics, Abdera, ROVEr, Ac, In, ABD-147, Small Cell Lung Cancer, Small-Cell Lung Cancer, SCLC, Large Cell Neuroendocrine Carcinoma, Large-Cell Neuroendocrine Carcinoma, LCNEC, Lung Cancer
Medical subject headings
Small Cell Lung Carcinoma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 225Ac-ABD147Drug

    A delta-like ligand 3 (DLL3)-targeting antibody fragment conjugated with a linker-chelator that effectively coordinates Ac-225

Study groups in NCT06736418
Study groupRoleWhat they receive
Phase 1a Dose Escalation GroupExperimental225Ac-ABD147 administered in escalating dose cohorts
Receives: Drug: 225Ac-ABD147
Phase 1b Dose Expansion GroupExperimentalExpansion Dose Level selected from Phase 1a Dose Escalation
Receives: Drug: 225Ac-ABD147

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ph 1a: Safety of 225Ac-ABD147 - Number and Grade of Adverse Events

    Incidence of adverse events and serious adverse events graded according to NCI-CTCAE v5.0; Clinically significant changes from baseline for laboratory values, ECGs, and vital signs will be evaluated as adverse events.

    Measured: 12 months

  2. Ph 1a: Tolerability of 225Ac-ABD147 - Number of Dose Limiting Toxicities

    Incidence and nature of dose limiting toxicities.

    Measured: 12 months

  3. Ph 1b: Safety of 225Ac-ABD147 to Determine the RP2D for Further Development - Number and Grade of Adverse Events

    Incidence of adverse events and serious adverse events graded according to NCI-CTCAE v5.0; Clinically significant changes from baseline for laboratory values, ECGs, and vital signs will be evaluated as adverse events.

    Measured: 12 months

  4. Ph 1b: Preliminary Efficacy of 225Ac-ABD147 - Overall Response Rate (ORR)

    ORR of confirmed complete response (CR) and partial response (PR) per investigator assessment using RECIST v1.1.

    Measured: 12 months

  5. Ph 1b: Preliminary Efficacy of 225Ac-ABD147 - Disease Control Rate (DCR)

    DCR per investigator assessment using RECIST v1.1.

    Measured: 12 months

  6. Ph 1b: Preliminary Efficacy of 225Ac-ABD147 - Duration of Response (DOR)

    DOR of confirmed CR and PR per investigator assessment using RECIST v1.1.

    Measured: 12 months

  7. Ph 1b: Preliminary Efficacy of 225Ac-ABD147 - Duration of Progression Free Survival (PFS)

    PFS per investigator assessment using RECIST v1.1.

    Measured: 12 months

  8. Ph 1b: Preliminary Efficacy of 225Ac-ABD147 - Overall Survival (OS)

    OS.

    Measured: 12 months

  9. Ph 1b: Preliminary Efficacy of 225Ac-ABD147 - PFS Rate

    6 monthly PFS rate per investigator assessment using RECIST v1.1.

    Measured: 12 months

  10. Ph 1b: Preliminary Efficacy of 225Ac-ABD147 - OS Rate

    6 monthly OS rate.

    Measured: 12 months

  11. Ph 1b: Biodistribution and Absorbed Dose - Measurement of Activity

    Whole blood radioactivity with whole blood gamma counting.

    Measured: 6 months

  12. Ph 1b: Immunogenicity of 225Ac-ABD147 - Measurement of Anti-drug Antibodies

    Anti-drug antibody to ABD147.

    Measured: 6 months

Secondary outcomes (9)
  1. Ph 1a: Determination of 225Ac-ABD147 Dose for Expansion (Phase 1b)

    The dose for expansion (Phase 1b) will be determined by integrating the totality of data obtained in Phase 1a.

    Measured: 12 months

  2. Ph 1a: Safety and Tolerability of Multiples Doses of 225Ac-ABD147 - Number and Grade of Adverse Events

    Incidence of adverse events and serious adverse events graded according to NCI-CTCAE v5.0; Clinically significant changes from baseline for laboratory values, ECGs, and vital signs will be evaluated as adverse events.

    Measured: 12 months

  3. Ph 1a: PK Profile of 225Ac-ABD147 - Peak Plasma Concentration (Cmax)

    Cmax.

    Measured: 6 months

  4. Ph 1a: PK Profile of 225Ac-ABD147 - Area under the plasma concentration versus time curve (AUC)

    AUC.

    Measured: 6 months

  5. Ph 1a: PK Profile of 225Ac-ABD147 - Volume of Distribution (Vd)

    Vd.

    Measured: 6 months

  6. Ph 1a: PK Profile of 225Ac-ABD147 - Elimination

    Half-life.

    Measured: 6 months

  7. Ph 1a: PK Profile of 225Ac-ABD147 - Elimination

    Clearance.

    Measured: 6 months

  8. Ph 1a: Immunogenicity of 225Ac-ABD147 - Measurement of Anti-drug antibodies

    Anti-drug antibody to ABD147.

    Measured: 6 months

  9. Ph 1a: Safety of 111In-ABD147 - Number and Grade of Adverse Events

    Incidence of adverse events and serious adverse events graded according to NCI-CTCAE v5.0.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2024
  2. Study start10 Mar 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose Escalation and Dose Expansion
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06736418
Sponsor's protocol ID
225Ac-ABD147-101
Status last verified
Apr 2026
First submitted
21 Nov 2024
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 225Ac-ABD147 in people with Small-Cell Lung Cancer (SCLC) and Large Cell Neuroendocrine Carcinoma of the Lung, run by Abdera Therapeutics Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ph 1a: Safety of 225Ac-ABD147 - Number and Grade of Adverse Events (time frame: 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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