This is a single-center, phase I study. Patients with metastatic clear cell renal cell carcinoma will be recruited in this study to (Phase A) evaluate using 68Ga-NYM096 PET/CT and to (Phase B) treat with 177Lu-NYM096. The study will be conducted in two phases. The purpose is Phase A: to evaluate the safety, tolerability, and imaging characteristics of 68Ga-NYM096 Phase B: to evaluate the safety, tolerability, and recommended phase 2 dose of 177Lu-NYM096
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients recruited in this study will undergo 68Ga-NYM096 PET/CT to evaluate the expression of carbonic anhydrase 9. Those with high CA9 expression will undergo 177Lu-NYM096 treatment, starting from 50mCi and increasing to 100mCi, 150mCi, 200mCi at most using a 3+3 design.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
(Phase A) The number to patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE)
Time frame: From the start of 68Ga-NYM096 PET/CT to 1 week after the 68Ga-NYM096 PET/CT
(Phase B) The number of patients with dose-limiting toxicity (DLT) after the first treatment of 177Lu-NYM096
177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The dose administrated to the participants will start at 50mCi and increase to 100, 150, and 200mCi at most in differnt dosing groups. While the AEs will be monitered for 8 months (2 months after the 4th dose), the decision whether the dose can increase to the next higher group will be decided only upon the DLT between the 1st and 2nd cycle.
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 8 weeks later.
(Phase A) Dosimetry of 68Ga-NYM096
Time frame: 1 month after the 68Ga-NYM096 PET/CT
(Phase A) Number of lesions detected by 68Ga-NYM096 PET/CT
Time frame: 1 week after the 68Ga-NYM096 PET/CT
(Phase A) Tumor uptake of 68Ga-NYM096
Time frame: 1 week after the 68Ga-NYM096 PET/CT
(Phase A) Optimal imaging window of 68Ga-NYM096 PET/CT
Time frame: 1 week after the 68Ga-NYM096 PET/CT
(Phase B) The number of patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE) after 177Lu-NYM096
177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The administration of 177Lu-NYM096 costs about half an hour.
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Time frame: From the start of 1st cycle of 177Lu-NYM096 administration (each cycle is 8 weeks) to 8 months later (8 weeks after the 4th cycle of treatment).
(Phase B) Dosimetry of 177Lu-NYM096
Time frame: 1 month after 177Lu-NYM096 treatment
(Phase B) Radioactive concentration of 177Lu-NYM096 in the blood at different time point after 177Lu-NYM096 administration
177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The administration of 177Lu-NYM096 costs about half an hour.
Time frame: From the start of 1st cycle of 177Lu-NYM096 administration (each cycle is 8 weeks) to 168 hours later.
(Phase B) Tumor uptake of 177Lu-NYM096 on post-therapy scan
Time frame: 1 week after 177Lu-NYM096 administration
(Phase B) ORR (overall response rate) of 177Lu-NYM096 treatment
177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression.
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) DCR (disease control rate) of 177Lu-NYM096 treatment
177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression.
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) PFS (progression free survival) of 177Lu-NYM096 treatment
177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression.
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) DOR (duration of response) of 177Lu-NYM096 treatment
177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression.
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) OS (overall survival) of 177Lu-NYM096 treatment
177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression. The survival info will be followed every 6 months until all-caused death of participant, assessed up to 60 months.
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to the date of first documented date of death from any cause, assessed up to 60 months.
(Phase B) PFS rate at 6 months of 177Lu-NYM096 treatment
177Lu-NYM096 will be delivered to participants up to 4 cycles with the same dosing amount. Each cycle will start 8 +/- 1 weeks after the previous cycle. The tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months).
Time frame: 6 month after the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) .