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 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
Sponsor: Abdera Therapeutics Inc.
Listed as NCT06736418, this observational or N/A phase trial focuses on Large Cell Neuroendocrine Carcinoma of the Lung and Small-Cell Lung Cancer (SCLC) and remains ongoing. Sponsored by Abdera Therapeutics Inc., it has been updated 8 times since 2025, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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).
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).
Status Flow
Change History
8 versions recorded-
Apr 28, 2026 — Present [daily]
Active Not Recruiting
Status: Recruiting → Active Not Recruiting · Phase: PHASE1 → None
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Feb 2026 — Apr 2026 [monthly]
Recruiting PHASE1
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Sep 2025 — Feb 2026 [monthly]
Recruiting PHASE1
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Jul 2025 — Sep 2025 [monthly]
Recruiting PHASE1
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May 2025 — Jul 2025 [monthly]
Recruiting PHASE1
▶ Show 3 earlier versions
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE1
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE1
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Jan 2025 — Mar 2025 [monthly]
Recruiting PHASE1
First recorded
Eligibility 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. 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.
Contact Information
- Abdera Therapeutics Inc.
For direct contact, visit the study record on ClinicalTrials.gov .