Clinical trial NCT06649682: 68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC
Official title: Safety, Tolerability, Imaging Characteristics, and Efficacy of 68Ga-NYM096/177Lu-NYM096 in the Treatment of Patients With Metastatic Clear Cell Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Clear Cell Renal Cell Carcinoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Age≥18y
2. Histologically or cytologically confirmed metastatic clear cell renal cell carcinoma
3. Progression after or cannot undergo standard therapy with tyrosine kinase inhibitor (TKI) treatment or TKI combined with immune checkpoint inhibitor treatment.
4. Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography / magnetic resonance imaging (CT/MRI)) documented within 4 weeks prior to the 68Ga-NYM096 administration which should be measurable per response evaluation criteria in solid tumors (RECIST) v1.1.
5. ECOG= 0 or 1
6. Written informed consent.
7. For Phase B: 68Ga-NYM096 should meet the imaging inclusion criteria

Exclusion Criteria:

1. Any major surgery within 12 weeks before enrollment
2. Inability to stay in the scanner bed and keep still for the duration of the scan
3. Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1
4. EGFR no higher than 30ml/min\*1.73m2
5. Inflammatory bowel disease
6. Phase A: TKI treatment within one week before 68Ga-NYM096 administration
7. Phase B: Participants who received any systemic antineoplastic therapy for the underlying disease and/or other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).
8. Any previous CA IX-targeting treatment
9. Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow
10. Pregnant or breastfeeding

Primary outcomes:
measure: (Phase A) The number to patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE)
timeFrame: From the start of 68Ga-NYM096 PET/CT to 1 week after the 68Ga-NYM096 PET/CT
measure: (Phase B) The number of patients with dose-limiting toxicity (DLT) after the first treatment of 177Lu-NYM096
timeFrame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 8 weeks later.
Secondary outcomes:
measure: (Phase A) Dosimetry of 68Ga-NYM096
timeFrame: 1 month after the 68Ga-NYM096 PET/CT
measure: (Phase A) Number of lesions detected by 68Ga-NYM096 PET/CT
timeFrame: 1 week after the 68Ga-NYM096 PET/CT
measure: (Phase A) Tumor uptake of 68Ga-NYM096
timeFrame: 1 week after the 68Ga-NYM096 PET/CT
measure: (Phase A) Optimal imaging window of 68Ga-NYM096 PET/CT
timeFrame: 1 week after the 68Ga-NYM096 PET/CT
measure: (Phase B) The number of patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE) after 177Lu-NYM096
timeFrame: 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).
measure: (Phase B) Dosimetry of 177Lu-NYM096
timeFrame: 1 month after 177Lu-NYM096 treatment
measure: (Phase B) Radioactive concentration of 177Lu-NYM096 in the blood at different time point after 177Lu-NYM096 administration
timeFrame: From the start of 1st cycle of 177Lu-NYM096 administration (each cycle is 8 weeks) to 168 hours later.
measure: (Phase B) Tumor uptake of 177Lu-NYM096 on post-therapy scan
timeFrame: 1 week after 177Lu-NYM096 administration
measure: (Phase B) ORR (overall response rate) of 177Lu-NYM096 treatment
timeFrame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
measure: (Phase B) DCR (disease control rate) of 177Lu-NYM096 treatment
timeFrame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
measure: (Phase B) PFS (progression free survival) of 177Lu-NYM096 treatment
timeFrame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
measure: (Phase B) DOR (duration of response) of 177Lu-NYM096 treatment
timeFrame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
measure: (Phase B) OS (overall survival) of 177Lu-NYM096 treatment
timeFrame: 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.
measure: (Phase B) PFS rate at 6 months of 177Lu-NYM096 treatment
timeFrame: 6 month after the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) .
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Uion Medical College Hospital
name: Li Huo, MD
role: PRINCIPAL_INVESTIGATOR
References: