RightFit
RecruitingPhase 1

A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors

BActinium-2: A Phase 1b, 2 Part, Multicenter, Open Label Study to Evaluate the Safety and Efficacy of Intravenous Administration of a B7-H3 Radiopharmaceutical ([225Ac]Ac AKY 2519) in Participants With B7-H3 Imaging Positive Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of [64Cu]Cu-AKY-2519 and/or [225Ac]Ac-AKY-2519 and how they move through the body, including radiation doses. It also looks for early signs that [225Ac]Ac-AKY-2519 fights cancer. It is for adults with certain solid tumors that have spread nearby or to other parts of the body and show the B7-H3 marker on imaging scans.

This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with B7-H3 imaging positive solid tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have cancer confirmed by a tissue or cell test: non-small cell lung cancer, extensive-stage small cell lung cancer, head and neck or esophageal squamous cell cancer, colorectal cancer, or prostate adenocarcinoma (gland cancer). The cancer must have spread nearby or to other parts of the body.
  • Have at least one tumor that can be measured on a CT scan using the study’s rules.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have organs that work well enough for the study.
  • Be able to give informed consent and follow study requirements.
  • If cancer has spread to the brain or spinal cord, it must have been treated, be stable, cause no symptoms, and not require corticosteroid medicines.

Who can't join

  • Have had treatment that targets B7-H3.
  • Have had targeted radiation treatment.
  • Have received an experimental drug within the past 28 days.
  • Have received chemotherapy, targeted therapy, a biologic drug, immune therapy, or radiation from a machine outside the body within the past 28 days.
  • Have poor heart function or significant heart disease.
  • Have another serious health condition that could limit study participation or make treatment side effects hard to assess.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age ≥ 18 years * Histologic or cytologic confirmation of locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma * Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1 * ECOG Performance Status of 0 or 1 * Adequate end-organ function * Ability to give informed consent and comply with study requirements * Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids Exclusion Criteria: * Prior treatment with a B7-H3 targeted therapy * Prior treatment with a targeted radiotherapy * Received an investigational agent within the previous 28 days * Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy within the previous 28 days * Impaired cardiac function or clinically significant cardiac disease * Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

Study sites (1)

FL