A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma

NCT04603846 | Unknown Phase 1

• 1 other identifier: NTL-LEES-2019-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  21 days after first dose

Secondary Outcomes (4)

• objective response rate

  12 months

• progression free survival

  12 months

• PD-L1 expression

  12 months

• TMB expression

  12 months

Study Arms (1)

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；

Drug: anti-PD-L1 antibody; Drug: albumin bound paclitaxel

Interventions

anti-PD-L1 antibody DRUG

Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.

Also known as: ZKAB001

Combined treatment group

albumin bound paclitaxel DRUG

Patients will receive 6 cycles of albumin bound paclitaxel 260mg/m2 on days 1 every 3 weeks .

Also known as: ABRAXANE

Combined treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Beijing Tumor Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

• 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.

  PMID: 39418340 DERIVED

MeSH Terms

Interventions

Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: October 27, 2020
• Study Start: September 10, 2020
• Primary Completion: October 1, 2022
• Study Completion: August 25, 2023
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)