Cancer
Conditions
Interventions
RYZ211 RYZ212
Sponsors
RayzeBio Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. - At least 18 years old at the time of signing the ICF 2. - Have biopsy-proven metastatic UC, HR+ and HER2– breast cancer, TNBC, or NSCLC per ASCO and CAP guidelines 3. - Have at least 1 RECIST v1.1-measurable tumor lesion on conventional imaging (CT or MRI) within 90 days of planned RYZ211 or RYZ212 administration 4. - Have an ECOG PS = 2 5. - For Women of Childbearing Potential (WOCBP): a. Have had a negative serum or urine pregnancy test within 48 hours of RYZ211 and RYZ212 administration. b. Agree to use highly effective contraception (CTCG 2020) for 7 months following RYZ211 and RYZ212 administration 6. - For sexually active male subjects: Must agree to use a condom during intercourse for 4 months following RYZ211 and RYZ212 administration and should not father a child or donate sperm during this period. Male subjects whose sexual partners are WOCBPs must agree to use a highly effective method of contraception (CTCG 2020) for 4 months following RYZ211 and RYZ212 administration. A condom is required to be used by both vasectomized men and those whose sexual partners are not WOCBPs, as well as during intercourse with a male partner, to prevent delivery of the drug via seminal fluid. 7. - Are willing and able to read and/or understand the details of the study and provide written informed consent prior to commencement of any study-specific assessments and procedures
Exclusion criteria
Exclusion criteria: 1. - Have a known allergy/hypersensitivity to 68Ga or 177Lu 2. - For subjects who are currently receiving treatment with TROP2-targeting ADCs such as sacituzumab govitecan or datopotamab deruxtecan, previous treatment with TROP2-targeting ADCs is allowed if discontinued at least 90 days prior to administration of RYZ211 and RYZ212. 3. - Have participated in other research studies and received active 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. - Are unable to comply with study protocol or undergo PET/CT and multiple timepoint SPECT and SPECT/CT imaging or are unable to stay immobile for a prolonged period 5. - Are planning antineoplastic therapy concurrent with RYZ211 and RYZ212 administration. Any planned antineoplastic therapy should be scheduled at least 1 day after RYZ211 and RYZ212 administration 6. - Have had persistent AEs of Grade > 2 (per NCI CTCAE v5.0) from chemotherapy, radiotherapy, or immunotherapy received within 4 weeks prior to IMP administration 7. - Have a concurrent primary malignancy other than UC, HR+ and HER2– breast cancer, TNBC, or NSCLC, except for adequately treated carcinoma in situ, nonmelanoma 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 RYZ211 and RYZ212 administration 8. - Have a current serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease or psychiatric disease/condition) that, in the opinion of the investigator, may interfere with the objectives and assessments of the study or subject safety or compliance 9. - For WOCBPs: Are pregnant or breastfeeding 10. - Are unable or unwilling to comply with the requirements of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - SUV (mean, maximum, and peak) of critical organs (blood pool, salivary glands, thyroid, pancreas, liver, kidney [cortex], bone) and tumors; tumor-to-normal organ tracer uptake ratios - Calculated mean TIAC (MBq · h/MBq), radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to critical organs (salivary glands, thyroid, pancreas, liver, kidneys, bone marrow) - Calculated mean TIAC (MBq · h/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 RYZ211 and RYZ212 in subjects with metastatic UC, HR+ and HER2–breast cancer, TNBC, or NSCLC | — |
Countries
South Africa
Contacts
Public ContactNikolina Katusa
Project Leader
Outcome results
None listed