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68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC | Clinical Trials | Clareo Health

SUSPENDEDPHASE1

68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC

Safety, Tolerability, Imaging Characteristics, and Efficacy of 68Ga-NYM096/177Lu-NYM096 in the Treatment of Patients With Metastatic Clear Cell Renal Cell Carcinoma

NCT06649682•Peking Union Medical College Hospital

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

November 21, 2024

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2027

Last Updated

December 31, 2025

Enrollment

ESTIMATED participants

Conditions

Clear Cell Renal Cell Carcinoma

Interventions

68Ga-NYM096 PET/CT and 177Lu-NYM096

DRUG

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

NCT06349642

Early Stage Triple-Negative Breast CarcinomaMetastatic Bladder Urothelial Carcinoma+25 more

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RECRUITINGPHASE1

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

NCT07300241

Clear Cell Renal Cell CarcinomaRenal Cell Carcinoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC

Inclusion Criteria

Exclusion Criteria

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

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