Advanced Urothelial CarcinomaPhase 1NCT04603846
A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma
A Phase 1 study testing anti-PD-L1 antibody and albumin bound paclitaxel in people with Advanced Urothelial Carcinoma, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
To evaluate the safety and efficacy of recombinant anti-PD-L1 monoclonal antibody injection (ZKAB001) combined with Albumin-bound paclitaxel in the treatment of Advanced urothelial carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Urothelial Carcinoma
- What is being tested?
- anti-PD-L1 antibody and albumin bound paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2020to 25 Aug 2023
- 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 ≥18 years old;
- Pathologically confirmed urothelial carcinoma;
- Terminal patients who have not received treatment or for the first time recurrence more than 6 months after the end of adjuvant chemotherapy after surgery;
- Evaluable lesions based on RECIST V1.1;
- ECOG score 0-1;
- Estimated life expectancy >3 months;
- The function of important organs meets the following requirements;
- The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- Previously received drugs targeting PD-1, PD-L1, PD-L2 or other treatments targeting T cell costimulation or checkpoint channels;
- Received systemic corticosteroid immunosuppressants 2 weeks before the study;
- Suffer from active meningeal metastasis or uncontrolled, untreated brain metastasis;
- Severe cardiovascular disease, such as New York Heart Association (New York Heart Association,NYHA standard) Grade 3-4 heart failure, unstable angina pectoris, unstable arrhythmia, or color heart photo indicates LVEF (left ventricular ejection fraction) < 50%;
- Previous hypersensitivity to monoclonal antibodies;
- The patient has known, active or suspected autoimmune diseases. The following conditions are allowed: skin diseases that do not require systemic treatment (such as vitiligo, psoriasis), type I diabetes, autoimmune hypothyroidism with hormone replacement therapy;
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- The study drug suffered from other active malignant tumors within 5 years before the first use of the drug. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., can be included in the group;
- Active hepatitis B or C (unless HBV-DNA titer < 500IU/mL or copy number < 1000copies/ml, HCV-RNA negative after antiviral treatment can be included in), HIV positive or known history of acquired immunodeficiency syndrome;
- Severe infection existed before screening, including but not limited to, infections requiring hospitalization, bacteremia, severe pneumonia, etc;
- There has been active pulmonary tuberculosis in the past year, whether treated or not;
- Live attenuated vaccine was used within 28 days prior to screening;
- Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
- Have received any other experimental drug treatment within 28 days prior to signing ICF;
- Pregnant or lactating women;
- Patients of childbearing age who refuse to use effective contraception;
- Other researchers believe that it is not suitable to join the group.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and efficacy of recombinant anti-PD-L1 monoclonal antibody injection (ZKAB001) combined with Albumin-bound paclitaxel in the treatment of Advanced urothelial carcinoma
Read the detailed description
This trial is designed to first include 6 subjects to confirm the dose safety. If the toxicity is intolerable, the dose of chemotherapeutic drugs will be reduced depending on the toxicity for further exploration.If it was tolerated, the recommended dose was determined, and the dose was extended. 14 patients were enrolled to further observe the safety and efficacy.
- Conditions
- Advanced Urothelial Carcinoma
- Being tested
- anti-PD-L1 antibody, albumin bound paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-PD-L1 antibodyDrug
Also called ZKAB001
Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
albumin bound paclitaxelDrug
Also called ABRAXANE
Patients will receive 6 cycles of albumin bound paclitaxel 260mg/m2 on days 1 every 3 weeks .
| Study group | Role | What they receive |
|---|---|---|
| Combined treatment group | Experimental | All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 6 cycles of albumin-bound paclitaxel 260mg/m2 d1，q3w； Receives: Drug: anti-PD-L1 antibody; Drug: albumin bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Adverse events of level 3 or above related to the study drug occurring within 21 days after the first dose as assessed by CTCAE v5.0.
Measured: 21 days after first dose
Recommended phase II dose (RP2D)
DLT occurs in no more than 1/6 subjects, this dose is defined as RP2D.
Measured: 21 days after first dose
Secondary outcomes (4)
objective response rate
Percentage of patients in partial and complete response
Measured: 12 months
progression free survival
time between first dose of study drug to disease progression
Measured: 12 months
PD-L1 expression
The positive rate of PD-L1 expression in tumor tissue.
Measured: 12 months
TMB expression
The positive rate of TMB expression in tumor tissue.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start10 Sep 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion25 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Urothelial CarcinomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603846
- Sponsor's protocol ID
- NTL-LEES-2019-06
- Status last verified
- Jan 2022
- First submitted
- 8 Sep 2020
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang B, Xiao J, Chi Z, Duan R, Cui C, Si L, Liu Y, Hu X, Liu Z, Xiang P, Li S, Yan X, Zhou L, Li J, Li Y, Yu X, Dai X, Li X, Guo J, Sheng X. Phase Ib study of anti-PD-L1 monoclonal antibody socazolimab in combination with nab-paclitaxel as first-line therapy for advanced urothelial carcinoma. Oncologist. 2025 Feb 6;30(2):oyae260. doi: 10.1093/oncolo/oyae260.
PubMed 39418340
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04603846
- Acronym / sponsor ID
- NTL-LEES-2019-06
- Conditions
- Advanced Urothelial Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 25 Aug 2023 (estimated)
- First posted
- 27 Oct 2020 (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.
To evaluate the safety and efficacy of recombinant anti-PD-L1 monoclonal antibody injection (ZKAB001) combined with Albumin-bound paclitaxel in the treatment of Advanced urothelial carcinoma
Detailed description
This trial is designed to first include 6 subjects to confirm the dose safety. If the toxicity is intolerable, the dose of chemotherapeutic drugs will be reduced depending on the toxicity for further exploration.If it was tolerated, the recommended dose was determined, and the dose was extended. 14 patients were enrolled to further observe the safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined treatment group | Experimental | Drug: anti-PD-L1 antibody, Drug: albumin bound paclitaxelAll patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 6 cycles of albumin-bound paclitaxel 260mg/m2 d1，q3w； |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old;
- Pathologically confirmed urothelial carcinoma;
- Terminal patients who have not received treatment or for the first time recurrence more than 6 months after the end of adjuvant chemotherapy after surgery;
- Evaluable lesions based on RECIST V1.1;
- ECOG score 0-1;
Key exclusion criteria (16 listed)
- Previously received drugs targeting PD-1, PD-L1, PD-L2 or other treatments targeting T cell costimulation or checkpoint channels;
- Received systemic corticosteroid immunosuppressants 2 weeks before the study;
- Suffer from active meningeal metastasis or uncontrolled, untreated brain metastasis;
- Severe cardiovascular disease, such as New York Heart Association (New York Heart Association,NYHA standard) Grade 3-4 heart failure, unstable angina pectoris, unstable arrhythmia, or color heart photo indicates LVEF (left ventricular ejection fraction) < 50%;
- Previous hypersensitivity to monoclonal antibodies;
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 |
|---|---|---|
| anti-PD-L1 antibodyAlso: ZKAB001Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks. | Drug | Combined treatment group |
| albumin bound paclitaxelAlso: ABRAXANEPatients will receive 6 cycles of albumin bound paclitaxel 260mg/m2 on days 1 every 3 weeks . | Drug | Combined treatment group |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 21 days after first dose
Adverse events of level 3 or above related to the study drug occurring within 21 days after the first dose as assessed by CTCAE v5.0.
Recommended phase II dose (RP2D)
Time frame: 21 days after first dose
DLT occurs in no more than 1/6 subjects, this dose is defined as RP2D.
4 secondary outcomes
objective response rate
Time frame: 12 months
progression free survival
Time frame: 12 months
PD-L1 expression
Time frame: 12 months
TMB expression
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 39418340Tang B, Xiao J, Chi Z, Duan R, Cui C, Si L, Liu Y, Hu X, Liu Z, Xiang P, Li S, Yan X, Zhou L, Li J, Li Y, Yu X, Dai X, Li X, Guo J, Sheng X. Phase Ib study of anti-PD-L1 monoclonal antibody socazolimab in combination with nab-paclitaxel as first-line therapy for advanced urothelial carcinoma. Oncologist. 2025 Feb 6;30(2):oyae260. doi: 10.1093/oncolo/oyae260.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 anti-PD-L1 antibody and albumin bound paclitaxel in people with Advanced Urothelial Carcinoma, run by Lee's Pharmaceutical Limited 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 8 inclusion and 16 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 24 Jan 2022. 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?
Dose limiting toxicity (DLT) (time frame: 21 days after first dose). 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?
On the ClinicalTrials.gov record for NCT04603846, which also lists 1 linked publication.
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 24 Jan 2022.