68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCC (NYCRRLT)

December 25, 2025 updated by: Peking Union Medical College Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Li Huo, MD
  • Phone Number: +86 186 1267 2038
  • Email: huoli@pumch.cn

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Imaging and therapy
68Ga-NYM096 PET/CT and 177Lu-NYM096
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
(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
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.
From the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) to 8 weeks later.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
(Phase A) Dosimetry of 68Ga-NYM096
Time Frame: 1 month after the 68Ga-NYM096 PET/CT
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
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
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
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).
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.
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
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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) .
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).
6 month after the start of 1st cycle of 177Lu-NYM096 treatment (each cycle is 8 weeks) .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Li Huo, MD, Peking Uion Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K6754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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