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

NCT06649682 | Suspended Phase 1

• 1 other identifier: K6754
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• (Phase A) The number to patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE)

  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.

  From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 8 weeks later.

Secondary Outcomes (14)

• (Phase A) Dosimetry of 68Ga-NYM096

  1 month after the 68Ga-NYM096 PET/CT

• (Phase A) Number of lesions detected by 68Ga-NYM096 PET/CT

  1 week after the 68Ga-NYM096 PET/CT

• (Phase A) Tumor uptake of 68Ga-NYM096

  1 week after the 68Ga-NYM096 PET/CT

• (Phase A) Optimal imaging window of 68Ga-NYM096 PET/CT

  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

  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).

Study Arms (1)

Imaging and therapy

EXPERIMENTAL

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

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

Interventions

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

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.

Imaging and therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18y
• Histologically or cytologically confirmed metastatic clear cell renal cell carcinoma
• Progression after or cannot undergo standard therapy with tyrosine kinase inhibitor (TKI) treatment or TKI combined with immune checkpoint inhibitor treatment.
• 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.
• ECOG= 0 or 1
• Written informed consent.

You may not qualify if:

• Any major surgery within 12 weeks before enrollment
• Inability to stay in the scanner bed and keep still for the duration of the scan
• Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1
• EGFR no higher than 30ml/min\*1.73m2
• Inflammatory bowel disease
• Phase A: TKI treatment within one week before 68Ga-NYM096 administration
• 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).
• Any previous CA IX-targeting treatment
• Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow
• Pregnant or breastfeeding

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Li Huo, MD

  Peking Uion Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 21, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CN (1)