A Phase 1/2 Study of [225Ac]-FPI-1434 Injection

Launched by FUSION PHARMACEUTICALS INC. · Nov 15, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called [225Ac]-FPI-1434 Injection for patients with advanced solid tumors, including types like endometrial, cervical, ovarian, and breast cancers. The goal is to determine how safe this treatment is, how well it works, and the best dose to use. The trial is open to adult patients whose tumors have not responded to standard treatments, or for whom no standard options are available. To participate, patients must have a confirmed diagnosis of a specific type of cancer and be in relatively good health with a life expectancy of more than three months.

Participants in this study can expect to receive the [225Ac]-FPI-1434 treatment and undergo regular check-ups to monitor their health and any side effects. The trial will also require some imaging tests to see how well the treatment is working. It’s important to know that certain health conditions or previous treatments may prevent someone from participating, so a thorough screening will be done before enrollment. Overall, this trial aims to explore a promising new option for patients with limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Pathologically documented, definitively diagnosed, advanced solid tumour that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy.
• • 2. Measurable or evaluable disease in accordance with RECIST 1.1.
• • 3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• • 4. Life expectancy of greater than 3 months as judged by the treating physician.
• • 5. Available tumour tissue (either archival or fresh biopsy) for IGF-1R immunohistochemistry. Submission of the tissue is not required prior to enrollment.
• • 6. Adequate heart, kidney, and liver function
• • 7. Adequate bone marrow reserves
• • 8. Ability to understand and the willingness to sign a written informed consent document.
• • Phase 2 Specific
• • 9. Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, metastatic, or recurrent solid tumour types: endometrial, cervical, ovarian, TNBC, HER 2-negative breast, HNSCC, ACC, or uveal melanoma.
• • 10. Have measurable disease per RECIST 1.1 Failure to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist or is not tolerable.
• • Imaging Eligibility
• • 11. Prior to the initial \[225Ac\]-FPI-1434 cycle: Sufficient target expression in at least 1 lesion following \[111In\]-FPI-1547 and SPECT imaging.
• Exclusion Criteria:
• • 1. Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment into this study.
• • 2. Contraindications to or inability to perform the required imaging procedures in this study (e.g., inability to lay flat during scan time)
• • 3. Uncontrolled brain metastasis, including but not limited to the need for treatment with steroids, surgery or radiation therapy.
• • 4. Anticancer therapy (including investigational agents) or external beam radiation therapy within 14 days of the dosing of \[111In\]-FPI-1547
• • 5. Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast cancer, cervical cancer, prostate) that have undergone potentially curative therapy are not excluded.
• • 6. Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception of residual grade 2 alopecia.
• • 7. Prior organ transplantation, including stem cell transplantation.
• • 8. Any prior treatment with nitrosoureas or actinomycin-D.
• • 9. Clinically relevant levels of protein in the urine
• • 10. Known or suspected allergies or contraindications to the Investigational Products or any component of the investigational drug formulation.
• • 11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements.
• • 12. Received \> 20 Gy prior radiation to large areas of the bone marrow