Imaging Agent 111In-ABD147 for Cancer

Overseen By Maya Aslam

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Thomas Hope

Disqualifiers: Allergy to antibodies, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, 111In-ABD147 (a radioactive tracer), to evaluate its effectiveness in detecting metastatic cancer in individuals with certain solid tumors, particularly those with neuroendocrine features. Participants will receive the imaging agent and undergo a special scan to determine if the cancer is detectable. Candidates for this trial include individuals with castration-resistant prostate cancer, high-grade neuroendocrine tumors, or other solid tumors that have spread. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this new imaging agent functions in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the imaging agent 111In-ABD147 is safe for detecting metastatic cancer?

Research has shown that 111In-ABD147 might be a safe imaging tool for detecting cancer. In studies, this tool locates tumors by attaching to a specific protein found on many cancer cells. Although these studies do not fully outline the safety details for 111In-ABD147, the trial phase offers some insight. As an early Phase 1 trial, the main goal is to assess the treatment's safety for participants. This means there might be limited safety information available now, but the trial aims to gather more data on how well participants tolerate it.

Participants in this trial will be closely monitored for any side effects after receiving the agent. This careful observation ensures participant safety as researchers learn more about how the agent functions in the body. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 111In-ABD147 because it offers a unique approach to imaging various cancer types, such as castration-resistant prostate cancer, high-grade neuroendocrine tumors, and solid tumors. Unlike traditional imaging agents, 111In-ABD147 is designed to provide clearer and more precise imaging results through SPECT/CT scans, potentially improving the detection and monitoring of tumors. This agent uses indium-111, a radioisotope that enhances imaging capabilities, allowing doctors to see cancer activity more accurately and potentially leading to better-targeted treatment plans. By offering a new level of imaging detail, 111In-ABD147 could significantly impact how these cancers are diagnosed and managed.

What evidence suggests that the imaging agent 111In-ABD147 is effective for detecting metastatic cancer?

Research has shown that 111In-ABD147 might help detect cancer spread in solid tumors. This imaging agent targets DLL3, a protein often found in certain cancer cells, especially those with neuroendocrine traits. In this trial, participants will receive 111In-ABD147 to evaluate its potential as a diagnostic tool for metastatic prostate cancer, high-grade neuroendocrine tumors, and other solid tumors. Although early results appear positive, more data is needed to confirm its effectiveness across different cancer types. ^{2 3 6 7 8}

Who Is on the Research Team?

Thomas A Hope, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with solid tumors, especially those with neuroendocrine features. Participants must have metastatic cancer and be suitable for imaging studies.

Inclusion Criteria

Ability to understand a written informed consent document, and the willingness to sign it.

I have prostate cancer that is resistant to hormonal therapy.

My cancer type does not affect my eligibility for this trial.

Exclusion Criteria

Known pregnancy.

Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.

Has known hypersensitivity to Chinese hamster ovary cell products.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single administration of 111In-ABD147 followed by SPECT/CT imaging 48 hours after injection

2 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 111In-ABD147

Trial Overview The trial tests a new imaging agent called 111In-ABD147 in combination with SPECT/CT scans to detect metastatic cancer in patients with solid tumors.

How Is the Trial Designed?

Group I: Cohort 3: Agnostic solid tumors Experimental Treatment 2 Interventions

Participants will receive a single administration of 185 MBq (5 mCi) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.

Group II: Cohort 2: High grade neuroendocrine tumor Experimental Treatment 2 Interventions

Participants will receive a single administration of 185 MBq (5 mCi) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.

Group III: Cohort 1: Castration resistant prostate cancer Experimental Treatment 2 Interventions

Participants will receive a single administration of 185 megabecquerels (MBq) (5 millicurie (mCi)) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.

Who Is Running the Clinical Trial?

Thomas Hope

Lead Sponsor

Trials

11

Recruited

1,800+

Abdera Therapeutics Inc.

Industry Sponsor

Trials

1

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07052760

NCT07052760 | Imaging of Solid Tumors Using DLL3 SPECT This is a single arm, pilot trial that evaluates the ability of a novel imaging agent (111In-ABD147) to detect metastatic cancer in participants with solid ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-04590

An Investigational Scan (111In-ABD147 SPECT/CT) for the ... 111In-ABD147 SPECT/CT may be a safe and effective imaging technique for diagnosing metastatic prostate, neuroendocrine, or other solid tumors. Eligibility ...

3. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT07052760

Imaging of Solid Tumors Using DLL3 SPECT This is a single arm, pilot trial that evaluates the ability of a novel imaging agent (111In-ABD147) to detect metastatic cancer in participants with solid ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/prostate-cancer

UCSF Prostate Cancer Clinical Trials — San Francisco Bay ... This is a single arm, pilot trial that evaluates the ability of a novel imaging agent (111In-ABD147) to detect metastatic cancer in participants ...

5. urotoday.com urotoday.com/conference-highlights/esmo-2024/esmo-2024-prostate-cancer/154835-esmo-2024-dll-3-targeted-therapy-for-neuroendocrine-prostate-cancer.html

ESMO 2024: DLL-3 Targeted Therapy for Neuroendocrine ... Efficacy outcomes were disappointing. The objective response rate in the overall cohort was 10.5%, and 22.2% in the DLL3+ cohort. The median ...

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 ... The Phase 1 trial is designed to evaluate the safety and tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of 225Ac- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434391/

Safety and Efficacy of Tarlatamab in Patients with ... Abstract. Purpose: Neuroendocrine prostate cancer (NEPC) is an aggressive form of prostate cancer with poor prognosis and limited treatment options.

8. unitedtheranostics.com unitedtheranostics.com/clinical-trials/

Clinical Trials 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 ...