Cancer
Conditions
Interventions
Sponsors
RayzeBio Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years old at the time of signing the informed consent form (ICF). 2. Biopsy proven metastatic clear cell RCC. 3. At least 1 RECIST v1.1-measurable tumour lesion on conventional imaging (CT or MRI) within 90 days of planned RYZ512 administration. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =2 5. For women of childbearing potential (WOCBP): a. Negative serum or urine pregnancy test within 48 hours of RYZ512 administration; b. Agreement to use highly effective contraception (CTCG 2020) for 7 months following RYZ512 administration. 6. Sexually active male subjects must agree to use a condom during intercourse for 4 months following RYZ512 administration and should not father a child or donate sperm during this period. Male subjects whose sexual partners are WOCBP must agree to use a highly effective method of contraception (CTCG 2020) for 4 months following RYZ512 administration. A condom is required to be used, also by vasectomized men and when sexual partners are not WOCBP, as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid. 7. Willingness and ability to read and/or understand the details of the study and provide written informed consent prior to any study-specific assessments and procedures commence.
Exclusion criteria
Exclusion criteria: 1. Known allergy/hypersensitivity to 177Lu or sulfonamides. 2. Subjects taking below mentioned medications that cannot be stopped 5 half-lives prior to RYZ512 administration and cannot be restarted until all study-related SPECT imaging is completed (may competitively bind with CAIX, potentially decreasing the ability of RYZ512 to bind to CAIX on cancer cells): Anticonvulsants: Topiramate; Antipsychotics: Sulpiride; Carbonic Anhydrase inhibitors: Sulthiame, acetazolamide, methazolamide, dorzolamide, brinzolamide, diclofenamide, ethoxzolamide, zonisamide; COX-2 Inhibitors: Celecoxib Sulfatase Inhibitors: COUMATE, EMATE; Sulfonamides: indisulam 3. Participation in other research studies and received active Investigational Medicinal Products (IMPs) within 30 days or 10 half-lives, whichever is longer, prior to screening; participants on long-term follow-up from other research studies who have not received any active IMPs within 30 days or 10 half-lives, whichever is longer, prior to screening are allowed. 4. Inability to comply with study protocol or undergo multiple timepoint SPECT and SPECT/CT imaging or unable to stay immobile for a prolonged period. 5. Planned antineoplastic therapy concurrent with RYZ512 administration; any planned antineoplastic therapy should be scheduled at least 1 day after RYZ512 administration. 6. Persistent AEs of > Grade 2 (per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 [NCI-CTCAE v5.0]) from chemotherapy, radiotherapy, or immunotherapy received within 4 weeks prior to RYZ512 administration. 7. Concurrent primary malignancy other than clear cell RCC, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin, or any other curatively treated malignancy that has achieved complete response and shows no evidence of disease within 90 days of RYZ512 administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence and severity of AEs by NCI CTCAE v5, including SAEs, and other safety findings. - Visual assessment of location, extent, and intensity of RYZ512 uptake in critical organs and tumors Calculated mean TIAC (MBq·hr/MBq), radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to critical organs (e.g., stomach, liver, kidneys, bone marrow) Calculated mean TIAC (MBq·hr/MBq) and radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to tumors Calculated whole-body effective dose (mSv/MBq | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the tolerability of RYZ512 in Subjects with Metastatic Clear Cell Cancer (RCC) | — |
Countries
South Africa
Contacts
Public ContactNikolina Katusa
Project Leader
Outcome results
None listed