Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1
20 participants
INTERVENTIONAL
2024-11-21
2027-10-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Imaging and therapy
68Ga-NYM096 PET/CT and 177Lu-NYM096
68Ga-NYM096 PET/CT and 177Lu-NYM096
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.
Interventions
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68Ga-NYM096 PET/CT and 177Lu-NYM096
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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Li Huo, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Uion Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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K6754
Identifier Type: -
Identifier Source: org_study_id