New Dual-Action drug targets Hard-to-Treat kidney cancer
NCT ID NCT06649682
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug called NYM096 in people with advanced clear cell kidney cancer that has spread. The study has two parts: first, using a low dose to see if it can light up tumors on scans, and second, giving higher doses to see if it can shrink tumors and find the safest dose. About 20 participants will be enrolled, and the main goal is to check safety and side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
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Other studies related to the condition(s) this trial covers.
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- Can a pill rewrite the genetic story of resistant kidney cancer?