A Phase 1/2 Trial of ADI-270 in ccRCC

Launched by ADICET THERAPEUTICS · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called ADI-270 for patients with clear cell renal cell carcinoma (ccRCC), which is a type of kidney cancer. The study aims to see how safe and effective this treatment is for people whose cancer has returned or spread after previous therapies. To be eligible for the trial, patients need to have a confirmed diagnosis of advanced ccRCC and must have already received specific treatments, including immune checkpoint inhibitors and VEGF inhibitors. Additionally, they should have at least one measurable tumor that can be monitored during the study.

Participants in this trial will receive ADI-270 and will be monitored for side effects and how well the treatment works. The study is currently recruiting patients aged 65 to 74 and is open to all genders. It’s important for potential participants to know that individuals with certain medical conditions, such as significant brain issues or those on high doses of corticosteroids, may not be eligible for the trial. This study represents an opportunity for patients to access a new treatment option and contribute to research that could benefit others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytologically confirmed clear cell RCC
• • 2. Documented evidence of advanced or metastatic diseases.
• • 3. Patients must have been treated with an immune checkpoint inhibitor and a VEGF inhibitor (the VEGF inhibitor must have been administered in the advanced and/or metastatic setting).
• • 4. At least one measurable target lesion according to RECIST 1.1
• • 5. At least three weeks, or 5 half-lives, whichever is shorter, from the last dose of the prior line of systemic therapy
• • 6. KPS ≥ 70
• Exclusion Criteria:
• • 1. Subjects with CNS metastases or spinal cord compression are not eligible, unless they have completed therapy and have discontinued the use of corticosteroids for at least 8 weeks and remained stable prior to enrollment.
• • 2. Clinically significant CNS dysfunction of any etiology in the opinion of the Investigator.
• • 3. Prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions (palliative radiotherapy to bone lesions must be completed at least 2 weeks prior to the first dose of LD).
• • 4. Active malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months
• • 5. Treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy within 6 weeks before initiating LD in this study.
• • 6. Receipt of CD70 targeted therapies for any indication
• • 7. Require corticosteroid therapy \> 5 mg per day of prednisone or equivalent.
• • 8. History of any form of primary immunodeficiency such as severe combined immunodeficiency disease.
• • 9. Presence of active autoimmune disease requiring ongoing systemic immunosuppressive therapy.