Urothelial Carcinoma (UC)Early Phase 1NCT07439120
Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors
A Early Phase 1 study testing ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 in people with Urothelial Carcinoma (UC), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is an open-label, single-arm, interventional clinical trial designed to investigate the safety of ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 in patients with advanced metastatic solid tumors; to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of ¹⁷⁷Lu-BRP-020063 in patients with metastatic solid tumors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma (UC)
- What is being tested?
- ⁶⁸Ga/¹⁷⁷Lu-BRP-020063
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2026to 31 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 ≥ 18 years, regardless of gender;
- Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);
- Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);
- Performance status (ECOG) score of 0-1;
- Adequate organ function:
- Complete Blood Count: White blood cell count ≥ 3.0 × 10⁹/L, neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelet count ≥ 75 × 10⁹/L;
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- Liver function: Total bilirubin ≤ 2.5 × ULN, alanine aminotransferase ≤ 3 × ULN, aspartate aminotransferase ≤ 3 × ULN;
- Renal function: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
- Coagulation function: Prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN;
- Subjects of childbearing potential must voluntarily adopt effective contraception during the treatment period and for 6 months after the last dose of the investigational drug (for females);
- Willing to participate in this trial and sign an informed consent form.
Who cannot join
- Previous treatment with Nectin-4-targeted drugs (including clinical trials);
- Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);
- Participation in drug or device clinical studies within 4 weeks prior to the first dose;
- Presence of severe or uncontrolled underlying diseases, including but not limited to:
- NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication;
- Severe cardiovascular/cerebrovascular or valvular diseases;
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- Poorly controlled diabetes or hypertension;
- Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia);
- Active infection within 4 weeks prior to the first dose;
- Women who are planning pregnancy, currently pregnant, or breastfeeding;
- Allergy to radioactive rays or other severe allergic history;
- History of neurological metastasis with associated symptoms;
- Concurrent other malignancies;
- Undergone general anesthesia surgery within 4 weeks prior to the first dose;
- Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai
Yan Xing, MD, +862163246311, xy.1@163.com
About this study
Official title: A Study Evaluating the Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga/177Lu-BRP-020063 in Patients With Advanced Metastatic Solid Tumors.
This study is an open-label, single-arm, interventional clinical trial designed to investigate the safety of ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 in patients with advanced metastatic solid tumors; to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of ¹⁷⁷Lu-BRP-020063 in patients with metastatic solid tumors; and to preliminarily explore its therapeutic efficacy. The study plans to enroll 10 patients to receive ⁶⁸Ga-BRP-020063 PET/CT imaging, among whom 5 patients positive for ⁶⁸Ga-BRP-020063 will be selected to receive a low dose of ¹⁷⁷Lu-BRP-020063. The results of this study will provide a basis for the design of subsequent studies involving higher doses of ¹⁷⁷Lu-BRP-020063.
- Conditions
- Urothelial Carcinoma (UC)
- Being tested
- ⁶⁸Ga/¹⁷⁷Lu-BRP-020063
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
⁶⁸Ga/¹⁷⁷Lu-BRP-020063Drug
68Ga-BRP-020063 Injection (Diagnostic Phase): All subjects will receive a single administration of 68Ga-BRP-020063 injection. The dose of 5 mCi (185 MBq), within an acceptable range of 3-7 mCi (111-259 MBq), will be delivered via rapid consecutive intravenous bolus injection in a volume not exceeding 10 mL, followed by a saline flush.
177Lu-BRP-020063 Injection (Therapeutic Phase): Five subjects who show positive results on the 68Ga-BRP-020063 PET/CT scan will be selected to receive a single administration of 177Lu-BRP-020063 injection. A dose of 40 mCi (1.48 GBq), within an acceptable range of 30-50 mCi (1.11-1.85 GBq), will be administered via intravenous infusion over approximately 20 minutes using an infusion pump, followed by a saline flush.
| Study group | Role | What they receive |
|---|---|---|
| ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 Treatment Arm | Experimental | Not described Receives: Drug: ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adeverse Events
Measured: From enrolment to 4 weeks after the first dose
Secondary outcomes (3)
PK Parameters
AUC(0-∞)
Measured: From administration up to 168 hours post-dose
Biodistribution
Perform whole-body SPECT/CT to determine radioactivity (%ID) in major organs over time for biodistribution assessment.
Measured: From administration up to 168 hours post-dose
Radiation Dosimetry
Measured: from administration up to 168 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start13 Apr 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma (UC)Studies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Xing, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439120
- Sponsor's protocol ID
- IIT-2026-030
- Status last verified
- Jun 2026
- First submitted
- 11 Feb 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga/177Lu-BRP-020063 in Patients With Advanced Metastatic Solid Tumors.
- ClinicalTrials.gov ID
- NCT07439120
- Acronym / sponsor ID
- IIT-2026-030
- Conditions
- Urothelial Carcinoma (UC)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (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 study is an open-label, single-arm, interventional clinical trial designed to investigate the safety of ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 in patients with advanced metastatic solid tumors; to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of ¹⁷⁷Lu-BRP-020063 in patients with metastatic solid tumors; and to preliminarily explore its therapeutic efficacy. The study plans to enroll 10 patients to receive ⁶⁸Ga-BRP-020063 PET/CT imaging, among whom 5 patients positive for ⁶⁸Ga-BRP-020063 will be selected to receive a low dose of ¹⁷⁷Lu-BRP-020063. The results of this study will provide a basis for the design of subsequent studies involving higher doses of ¹⁷⁷Lu-BRP-020063.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 Treatment Arm | Experimental | Drug: ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years, regardless of gender;
- Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);
- Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);
- Performance status (ECOG) score of 0-1;
- Adequate organ function:
Key exclusion criteria (15 listed)
- Previous treatment with Nectin-4-targeted drugs (including clinical trials);
- Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);
- Participation in drug or device clinical studies within 4 weeks prior to the first dose;
- Presence of severe or uncontrolled underlying diseases, including but not limited to:
- Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia);
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/¹⁷⁷Lu-BRP-02006368Ga-BRP-020063 Injection (Diagnostic Phase): All subjects will receive a single administration of 68Ga-BRP-020063 injection. The dose of 5 mCi (185 MBq), within an acceptable range of 3-7 mCi (111-259 MBq), will be delivered via rapid consecutive intravenous bolus injection in a volume not exceeding 10 mL, followed by a saline flush. 177Lu-BRP-020063 Injection (Therapeutic Phase): Five subjects who show positive results on the 68Ga-BRP-020063 PET/CT scan will be selected to receive a single administration of 177Lu-BRP-020063 injection. A dose of 40 mCi (1.48 GBq), within an acceptable range of 30-50 mCi (1.11-1.85 GBq), will be administered via intravenous infusion over approximately 20 minutes using an infusion pump, followed by a saline flush. | Drug | ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 Treatment Arm |
Primary outcome
Adeverse Events
Time frame: From enrolment to 4 weeks after the first dose
3 secondary outcomes
PK Parameters
Time frame: From administration up to 168 hours post-dose
Biodistribution
Time frame: From administration up to 168 hours post-dose
Radiation Dosimetry
Time frame: from administration up to 168 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 in people with Urothelial Carcinoma (UC), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Xing, Dr. (+862163246311, xy.1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adeverse Events (time frame: From enrolment to 4 weeks after the first dose). 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 3 Jun 2026.