Prostate CancerPhase 1/2NCT06081686
Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
A Phase 1/2 study testing Phase I:[177Lu]Lu-XT033 Injection and Phase II:[177Lu]Lu-XT033 Injection in people with Prostate Cancer, run by Sinotau Pharmaceutical Group at 2 sites in China.
Trial summary
This was a multicenter, open-label, phase I/II study to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, and efficacy of [177Lu] Lu-XT033 injection in patients with metastatic prostate cancer, including a phase I study and a phase II extension study. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Phase I:[177Lu]Lu-XT033 Injection and Phase II:[177Lu]Lu-XT033 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesChina
- Study dates
- 13 Sep 2023to Dec 2025
- Phase
- Phase 1/2
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have the ability to understand and sign an approved informed consent form (ICF).
- Patients must be >= 18 and <＝80 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must have a life expectancy >6 months.
- Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
- Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
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- Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
- Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)； Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens.
- Patients must have progressive mCRPC.
- Patients must have adequate organ function。
- Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.
Who cannot join
- Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
- Known other malignancies.
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
- Known hypersensitivity to the components of the study therapy or its analogs.
- A superscan as seen in the baseline bone scan.
- Patients with a history of Central Nervous System (CNS) metastases.
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100042
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Phase I/II Study to Evaluate the Safety and Tolerability, Radiation Dosimetry and Pharmacokinetics, and Efficacy of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
This was a multicenter, open-label, phase I/II study to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, and efficacy of [177Lu] Lu-XT033 injection in patients with metastatic prostate cancer, including a phase I study and a phase II extension study.
Read the detailed description
The study for each participant consisted of a Screening period, a Treatment period and a Follow-up period.
In phase I,Six subjects were enrolled in the 1.11 Gbq (30 mCi) group of [177Lu] Lu-XT033 Injection. The last subject in this group completed the 4-week observation period after the first dose, With the consent of the Safety Monitoring Committee (SRC), 6 subjects were enrolled in the 1.85 Gbq (50 mCi) group. Both groups used 8 ± 1 weeks as the dosing interval for a total of 4 doses.In phase II,Subjects who met the inclusion and exclusion criteria were treated with [177Lu] Lu-XT033 injection at the recommended phase II dose（RP2D）.After Cycle 4 treatment and prior to Cycle 5 treatment, the investigator assessed the following criteria to determine whether:
The patient showed evidence of response (i.e. radiological, PSA, clinical benefit)
The patient had signs of residual disease on CT with contrast/MRI or bone scan
The patient had shown good tolerance to the [177Lu] Lu-XT033 Injection
If the patient met all of the criteria above and agreed to continue with additional treatment of [177Lu] Lu-XT033, the Investigator could administer 2 additional cycles. A maximum of 6 cycles of [177Lu] Lu-XT033 as allowed.
All subjects continued to undergo safety, tolerability, and efficacy assessments until the study-specified visit occurred or the subject was lost to follow-up or death whichever came first.
- Conditions
- Prostate Cancer
- Being tested
- Phase I:[177Lu]Lu-XT033 Injection, Phase II:[177Lu]Lu-XT033 Injection
- Keywords
- Prostate Cancer, [177Lu]Lu-XT033 Injection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I:[177Lu]Lu-XT033 InjectionDrug
Six subjects were enrolled in the 1.11 Gbq (30 mCi) group of [177Lu] Lu-XT033 Injection. The last subject in this group completed the 4-week observation period after the first dose, With the consent of the Safety Monitoring Committee (SRC), 6 subjects were enrolled in the 1.85 Gbq (50 mCi) group. Both groups used 8 ± 1 weeks as the dosing interval .
Phase II:[177Lu]Lu-XT033 InjectionDrug
Patients received [177Lu]Lu-XT033 Injection every 8 weeks (+/- 1 week) for a maximum of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase I:[177Lu]Lu-XT033 Injection | Experimental | During dose verification phase,Patients received [177Lu]Lu-XT033 Injection 1.11Gbq（30mCi）/1.85Gbq（50mCi）intravenously every 8 weeks (+/- 1 week) for a maximum of 6 cycles. Receives: Drug: Phase I:[177Lu]Lu-XT033 Injection |
| Phase II:[177Lu]Lu-XT033 Injection | Experimental | During dose expansion phase,patients received [177Lu]Lu-XT033 Injection at R2PD based on phase I. Receives: Drug: Phase II:[177Lu]Lu-XT033 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
For phase I:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])of [177Lu]Lu-XT033 on dose 1.11Gbq and 1.85Gbq
To evaluate the safety and tolerability of [177Lu]Lu-XT033 Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc
Measured: Through study completion, assessed up to 2 years.
For phase I：Whole body and organ uptake of [177Lu]Lu-XT033 Injection
Quantitate the absorbed radiation doses (expressed as Gy/MBq) of administered [177Lu]Lu-XT033 to kidneys, liver, lungs, spleen, bone/red marrow and salivary glands.
Measured: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
For phase I：Maximum plasma concentration (Cmax) of Lutetium [Lu 177] Lu-XT033 in patients.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Measured: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
For phase I：Time of observed drug concentration occurrence (Tmax) of Lutetium [Lu 177] Lu-XT033 in patients.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
Measured: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
For phase I：Area Under plasma concentration-time Curve from time 0 to 168 hours (AUC0-168) of Lutetium [Lu 177] Lu-XT033 in patients.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC0-168 will be listed and summarized using descriptive statistics.
Measured: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
For phase II:Prostate-specific Antigen 50 (PSA50) Response
PSA50 response was defined as the proportion of participants who had a >= 50% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later.
Measured: Through study completion, assessed up to 2 years.
Secondary outcomes (11)
For phase I:Prostate-specific Antigen 50 (PSA50) Response
PSA50 response was defined as the proportion of participants who had a >= 50% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later.
Measured: Through study completion, assessed up to 2 years.
For phase I/II:Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3)
Best percentage change from baseline in PSA level was defined as the maximum percent decrease at any time post-baseline.
Measured: Through study completion, assessed up to 2 years.
For phase I/II:Time to PSA progression
PSA progression was defined as: 1) Where a decline from baseline was documented, date that a >= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained at least 3 weeks later. Rises in PSA within the first 12 weeks of the date of first dose were ignored; 2) Where no decline from baseline was documented, PSA progression was defined as a >= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks from the date of first dose (without confirmation) as specified in the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines.
Measured: Through study completion, assessed up to 2 years.
For phase I/II:Radiographic Progression-free Survival (rPFS)
Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of enrollment to the date of radiographic disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause.
Measured: Through study completion, assessed up to 2 years.
For phase I/II:Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline.
Measured: Through study completion, assessed up to 2 years.
For phase I/II: Duration of Response (DOR)
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause .
Measured: Through study completion, assessed up to 2 years.
For phase I/II:Disease Control Rate (DCR)
Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1.
Measured: Through study completion, assessed up to 2 years.
For phase I/II:Health related quality of life(HRQOL)
Patient evaluation with questionnaires regarding Quality of Life .
Measured: Through study completion, assessed up to 2 years.
For phase I/II:Time to First Symptomatic Skeletal Event (SSE)
Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of enrollment to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause.
Measured: Through study completion, assessed up to 2 years.
For phase I/II:Overall Survival (OS)
Overall Survival (OS) was defined as the time (in months) from the date of enrollment to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date.
Measured: Through study completion, assessed up to 2 years.
For phase II:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])of [177Lu]Lu-XT033
To evaluate the safety and tolerability of [177Lu]Lu-XT033 Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc
Measured: Through study completion, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start13 Sep 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dingwei Ye, Principal investigator, Fudan UniversityZhi Yang, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081686
- Sponsor's protocol ID
- XT-XTR010-1-01
- Status last verified
- May 2024
- First submitted
- 25 Aug 2023
- Last updated
- 3 May 2024
- 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study to Evaluate the Safety and Tolerability, Radiation Dosimetry and Pharmacokinetics, and Efficacy of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT06081686
- Acronym / sponsor ID
- XT-XTR010-1-01
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, [177Lu]Lu-XT033 Injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Oct 2023 (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 was a multicenter, open-label, phase I/II study to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, and efficacy of [177Lu] Lu-XT033 injection in patients with metastatic prostate cancer, including a phase I study and a phase II extension study.
Detailed description
The study for each participant consisted of a Screening period, a Treatment period and a Follow-up period.
In phase I,Six subjects were enrolled in the 1.11 Gbq (30 mCi) group of [177Lu] Lu-XT033 Injection. The last subject in this group completed the 4-week observation period after the first dose, With the consent of the Safety Monitoring Committee (SRC), 6 subjects were enrolled in the 1.85 Gbq (50 mCi) group. Both groups used 8 ± 1 weeks as the dosing interval for a total of 4 doses.In phase II,Subjects who met the inclusion and exclusion criteria were treated with [177Lu] Lu-XT033 injection at the recommended phase II dose（RP2D）.After Cycle 4 treatment and prior to Cycle 5 treatment, the investigator assessed the following criteria to determine whether:
The patient showed evidence of response (i.e. radiological, PSA, clinical benefit)
The patient had signs of residual disease on CT with contrast/MRI or bone scan
The patient had shown good tolerance to the [177Lu] Lu-XT033 Injection
If the patient met all of the criteria above and agreed to continue with additional treatment of [177Lu] Lu-XT033, the Investigator could administer 2 additional cycles. A maximum of 6 cycles of [177Lu] Lu-XT033 as allowed.
All subjects continued to undergo safety, tolerability, and efficacy assessments until the study-specified visit occurred or the subject was lost to follow-up or death whichever came first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I:[177Lu]Lu-XT033 Injection | Experimental | Drug: Phase I:[177Lu]Lu-XT033 InjectionDuring dose verification phase,Patients received [177Lu]Lu-XT033 Injection 1.11Gbq（30mCi）/1.85Gbq（50mCi）intravenously every 8 weeks (+/- 1 week) for a maximum of 6 cycles. |
| Phase II:[177Lu]Lu-XT033 Injection | Experimental | Drug: Phase II:[177Lu]Lu-XT033 InjectionDuring dose expansion phase,patients received [177Lu]Lu-XT033 Injection at R2PD based on phase I. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have the ability to understand and sign an approved informed consent form (ICF).
- Patients must be >= 18 and <＝80 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must have a life expectancy >6 months.
- Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
Key exclusion criteria (7 listed)
- Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
- Known other malignancies.
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
- Known hypersensitivity to the components of the study therapy or its analogs.
- A superscan as seen in the baseline bone scan.
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 |
|---|---|---|
| Phase I:[177Lu]Lu-XT033 InjectionSix subjects were enrolled in the 1.11 Gbq (30 mCi) group of [177Lu] Lu-XT033 Injection. The last subject in this group completed the 4-week observation period after the first dose, With the consent of the Safety Monitoring Committee (SRC), 6 subjects were enrolled in the 1.85 Gbq (50 mCi) group. Both groups used 8 ± 1 weeks as the dosing interval . | Drug | Phase I:[177Lu]Lu-XT033 Injection |
| Phase II:[177Lu]Lu-XT033 InjectionPatients received [177Lu]Lu-XT033 Injection every 8 weeks (+/- 1 week) for a maximum of 6 cycles. | Drug | Phase II:[177Lu]Lu-XT033 Injection |
Primary outcome
For phase I:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])of [177Lu]Lu-XT033 on dose 1.11Gbq and 1.85Gbq
Time frame: Through study completion, assessed up to 2 years.
To evaluate the safety and tolerability of [177Lu]Lu-XT033 Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc
For phase I：Whole body and organ uptake of [177Lu]Lu-XT033 Injection
Time frame: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
Quantitate the absorbed radiation doses (expressed as Gy/MBq) of administered [177Lu]Lu-XT033 to kidneys, liver, lungs, spleen, bone/red marrow and salivary glands.
For phase I：Maximum plasma concentration (Cmax) of Lutetium [Lu 177] Lu-XT033 in patients.
Time frame: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
For phase I：Time of observed drug concentration occurrence (Tmax) of Lutetium [Lu 177] Lu-XT033 in patients.
Time frame: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
For phase I：Area Under plasma concentration-time Curve from time 0 to 168 hours (AUC0-168) of Lutetium [Lu 177] Lu-XT033 in patients.
Time frame: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC0-168 will be listed and summarized using descriptive statistics.
For phase II:Prostate-specific Antigen 50 (PSA50) Response
Time frame: Through study completion, assessed up to 2 years.
PSA50 response was defined as the proportion of participants who had a >= 50% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later.
11 secondary outcomes
For phase I:Prostate-specific Antigen 50 (PSA50) Response
Time frame: Through study completion, assessed up to 2 years.
For phase I/II:Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3)
Time frame: Through study completion, assessed up to 2 years.
For phase I/II:Time to PSA progression
Time frame: Through study completion, assessed up to 2 years.
For phase I/II:Radiographic Progression-free Survival (rPFS)
Time frame: Through study completion, assessed up to 2 years.
For phase I/II:Overall Response Rate (ORR)
Time frame: Through study completion, assessed up to 2 years.
For phase I/II: Duration of Response (DOR)
Time frame: Through study completion, assessed up to 2 years.
For phase I/II:Disease Control Rate (DCR)
Time frame: Through study completion, assessed up to 2 years.
For phase I/II:Health related quality of life(HRQOL)
Time frame: Through study completion, assessed up to 2 years.
For phase I/II:Time to First Symptomatic Skeletal Event (SSE)
Time frame: Through study completion, assessed up to 2 years.
For phase I/II:Overall Survival (OS)
Time frame: Through study completion, assessed up to 2 years.
For phase II:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])of [177Lu]Lu-XT033
Time frame: Through study completion, assessed up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- 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. This study is not recruiting at the moment.
Dingwei Ye principal investigator
Fudan University
Zhi Yang principal investigator
Peking University Cancer Hospital & Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phase I:[177Lu]Lu-XT033 Injection and Phase II:[177Lu]Lu-XT033 Injection in people with Prostate Cancer, run by Sinotau Pharmaceutical Group at 2 sites 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 7 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: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Shan Zhang (010-52805710, zhangshan@sinotau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For phase I:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])of [177Lu]Lu-XT033 on dose 1.11Gbq and 1.85Gbq (time frame: Through study completion, assessed up to 2 years.). The study lists 6 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 3 May 2024.