Clear Cell Renal Cell CarcinomaPhase 1NYCRRLTNCT06649682
68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC
A Phase 1 study testing 68Ga-NYM096 PET/CT and 177Lu-NYM096 in people with Clear Cell Renal Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- 68Ga-NYM096 PET/CT and 177Lu-NYM096
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2024to Oct 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- For Phase B: 68Ga-NYM096 should meet the imaging inclusion criteria
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Safety, Tolerability, Imaging Characteristics, and Efficacy of 68Ga-NYM096/177Lu-NYM096 in the Treatment of Patients With Metastatic Clear Cell Renal Cell Carcinoma
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
- Being tested
- 68Ga-NYM096 PET/CT and 177Lu-NYM096
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NYM096 PET/CT and 177Lu-NYM096Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Imaging and therapy | Experimental | 68Ga-NYM096 PET/CT and 177Lu-NYM096 Receives: Drug: 68Ga-NYM096 PET/CT and 177Lu-NYM096 |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Phase A) The number to patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE)
Measured: 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.
Measured: 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
Measured: 1 month after the 68Ga-NYM096 PET/CT
(Phase A) Number of lesions detected by 68Ga-NYM096 PET/CT
Measured: 1 week after the 68Ga-NYM096 PET/CT
(Phase A) Tumor uptake of 68Ga-NYM096
Measured: 1 week after the 68Ga-NYM096 PET/CT
(Phase A) Optimal imaging window of 68Ga-NYM096 PET/CT
Measured: 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
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 administration of 177Lu-NYM096 costs about half an hour.
Measured: 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).
(Phase B) Dosimetry of 177Lu-NYM096
Measured: 1 month after 177Lu-NYM096 treatment
(Phase B) Radioactive concentration of 177Lu-NYM096 in the blood at different time point after 177Lu-NYM096 administration
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 administration of 177Lu-NYM096 costs about half an hour.
Measured: From the start of 1st cycle of 177Lu-NYM096 administration (each cycle is 8 weeks) to 168 hours later.
(Phase B) Tumor uptake of 177Lu-NYM096 on post-therapy scan
Measured: 1 week after 177Lu-NYM096 administration
(Phase B) ORR (overall response rate) of 177Lu-NYM096 treatment
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 tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression.
Measured: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) DCR (disease control rate) of 177Lu-NYM096 treatment
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 tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression.
Measured: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) PFS (progression free survival) of 177Lu-NYM096 treatment
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 tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression.
Measured: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) DOR (duration of response) of 177Lu-NYM096 treatment
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 tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression.
Measured: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) OS (overall survival) of 177Lu-NYM096 treatment
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 tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months) and every 3 months after the end of the 4th cycle until 2 years after treatment start or tumor progression. The survival info will be followed every 6 months until all-caused death of participant, assessed up to 60 months.
Measured: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to the date of first documented date of death from any cause, assessed up to 60 months.
(Phase B) PFS rate at 6 months of 177Lu-NYM096 treatment
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 tumor reponse will be evaluated before each cycle during the treatment (roughly every 2 months).
Measured: 6 month after the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start21 Nov 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Why it stopped: This trial has been suspended given the concerns of stomach adverse effect in the first dose of 177Lu-NYM096 treatment (one patient developed grade 3 radiation-induced gastritis).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Huo, MD, Principal investigator, Peking Uion Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649682
- Sponsor's protocol ID
- K6754
- Acronym
- NYCRRLT
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Imaging Characteristics, and Efficacy of 68Ga-NYM096/177Lu-NYM096 in the Treatment of Patients With Metastatic Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06649682
- Acronym / sponsor ID
- NYCRRLT / K6754
- Conditions
- Clear Cell Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: This trial has been suspended given the concerns of stomach adverse effect in the first dose of 177Lu-NYM096 treatment (one patient developed grade 3 radiation-induced gastritis).
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging and therapy | Experimental | Drug: 68Ga-NYM096 PET/CT and 177Lu-NYM09668Ga-NYM096 PET/CT and 177Lu-NYM096 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NYM096 PET/CT and 177Lu-NYM096Patients 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. | Drug | Imaging and therapy |
Primary outcome
(Phase A) The number to patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE)
Time frame: 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
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 8 weeks later.
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.
14 secondary outcomes
(Phase A) Dosimetry of 68Ga-NYM096
Time frame: 1 month after the 68Ga-NYM096 PET/CT
(Phase A) Number of lesions detected by 68Ga-NYM096 PET/CT
Time frame: 1 week after the 68Ga-NYM096 PET/CT
(Phase A) Tumor uptake of 68Ga-NYM096
Time frame: 1 week after the 68Ga-NYM096 PET/CT
(Phase A) Optimal imaging window of 68Ga-NYM096 PET/CT
Time frame: 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
Time frame: 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).
(Phase B) Dosimetry of 177Lu-NYM096
Time frame: 1 month after 177Lu-NYM096 treatment
(Phase B) Radioactive concentration of 177Lu-NYM096 in the blood at different time point after 177Lu-NYM096 administration
Time frame: From the start of 1st cycle of 177Lu-NYM096 administration (each cycle is 8 weeks) to 168 hours later.
(Phase B) Tumor uptake of 177Lu-NYM096 on post-therapy scan
Time frame: 1 week after 177Lu-NYM096 administration
(Phase B) ORR (overall response rate) of 177Lu-NYM096 treatment
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) DCR (disease control rate) of 177Lu-NYM096 treatment
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) PFS (progression free survival) of 177Lu-NYM096 treatment
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) DOR (duration of response) of 177Lu-NYM096 treatment
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 2 years later.
(Phase B) OS (overall survival) of 177Lu-NYM096 treatment
Time frame: From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to the date of first documented date of death from any cause, assessed up to 60 months.
(Phase B) PFS rate at 6 months of 177Lu-NYM096 treatment
Time frame: 6 month after the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. Available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Huo, MD principal investigator
Peking Uion Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-NYM096 PET/CT and 177Lu-NYM096 in people with Clear Cell Renal Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Phase A) The number to patients with treatment-emergent adverse event (TEAE) and serious adverse event (SAE) (time frame: From the start of 68Ga-NYM096 PET/CT to 1 week after the 68Ga-NYM096 PET/CT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.