To hear about similar clinical trials, please enter your email below
Trial Title:
68Ga-NYM096/177Lu-NYM096 in Metastatic CcRCC
NCT ID:
NCT06649682
Condition:
Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-NYM096 PET/CT and 177Lu-NYM096
Description:
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.
Arm group label:
Imaging and therapy
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Huo, MD
Phone:
+86 186 1267 2038
Email:
huoli@pumch.cn
Contact backup:
Last name:
Wenjia Zhu, MD
Phone:
+86 186 1408 0164
Email:
zhuwenjia_pumc@163.com
Contact backup:
Last name:
Li Huo, MD
Contact backup:
Last name:
Wenjia Zhu, MDD
Start date:
November 2024
Completion date:
October 2027
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06649682
