AzTrials
AzTrials

Biliary Tract CancerPhase 1NCT04608786

A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer

A Phase 1 study testing ZKAB001 5mg/kg and Capecitabine in people with Biliary Tract Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a Phase Ib, open-label,single-arm, clinical study, aiming to investigate the safety, tolerability and pharmacokinetics of ZKAB001 (a fully human monoclonal antibody targeting the Programmed Death - Ligand 1 (PD-L1) membrane receptor ) combined with capecitabine as adjuvant chemotherapy for patients with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
ZKAB001 5mg/kg and Capecitabine
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
1 Feb 2021to 1 Dec 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

  • both men and women, age ≥ 18 years old；
  • A histopathological or cytological diagnosis of gallbladder cancer and extrahepatic cholangiocarcinoma after radical resection
  • Postoperative pathological stage is T2-4 or N1 R0/R1 resection；
  • No more than 12 weeks from radical resection；
  • Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;
  • Estimated life expectancy >6 months;
Show all 10Show fewer
  • Biliary drainage is in good condition, no current infection ;
  • Have not received radiotherapy, chemotherapy, or immunotherapy for the primary tumor;
  • The function of important organs meets the following requirements:
  • Blood routine test: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥100g/L; (2) Biochemical tests : ALT, AST ≤ 2.5×ULN; ALB≥ 35g/L;total bilirubin ≤3×ULN; serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥50 mL/min(Crockcroft-Gault formula); 10.Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.

Who cannot join

  • Local recurrence or distant metastasis (including ascites or malignant pleural effusion);
  • Severe cardiovascular disease, such as New York Heart Association (New York Heart Association, NYHA standard) heart failure above grade 2, unstable angina, unstable arrhythmia, or color photos of the heart suggest LVEF (left ventricular ejection fraction) )<50%;
  • Known allergy or hypersensitivity to monoclonal antibodies or fluorouracil drugs or their analogues;
  • Subjects with known, active or suspicious autoimmune diseases, who are in a stable state and do not require systemic immunosuppressive therapy can be included in the group;
  • Subjects were treated with immunosuppressants or systemic or absorbable topical corticosteroids within 2 weeks before the first study to achieve immunosuppressive purposes (>10mg/day prednisone or equivalent dose) ;
  • Suffered from other active malignancies within 5 years before the first administration of the study drug. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in the group;
Show all 16Show fewer
  • Active viral hepatitis (such as hepatitis B, hepatitis C, unless antiviral treatment is given and the HBV or HCV viral load is below the minimum detection limit can be considered for inclusion), HIV positive or a known history of acquired immunodeficiency syndrome ；
  • Any active infection that requires systemic anti-infective treatment occurs within 14 days before the first medication;
  • Have active tuberculosis in the past 1 year, regardless of treatment;
  • Live attenuated vaccines have been used within 28 days before screening;
  • Subjects who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
  • Have received any other experimental drug treatment within 28 days before signing the ICF;
  • People who have difficulty swallowing or have known drug absorption disorders;
  • Women who are pregnant or breastfeeding;
  • Subjects of childbearing age who refuse to use effective contraceptive measures;
  • Situations that other researchers think are not suitable for inclusion. -

Trial locations and contacts

1 site in 1 country.

China1 site

  • Renji Hospital Affiliated to School of Medicine, Shanghai Jiaotong University

    Shanghai

Other trials in China

About this study

Official title: A Single-arm, Open-label，Phase Ib Clinical Study of ZKAB001 Combined With Capecitabine in Adjuvant Therapy for Patients With Biliary Tract Cancer After Radical Resection

This is a Phase Ib, open-label,single-arm, clinical study, aiming to investigate the safety, tolerability and pharmacokinetics of ZKAB001 (a fully human monoclonal antibody targeting the Programmed Death - Ligand 1 (PD-L1) membrane receptor ) combined with capecitabine as adjuvant chemotherapy for patients with biliary tract cancers after radical resection.After completing 8 courses of combined treatment ,ZKAB001 was continued to be administered separately once 3 weeks for a total of 16 cycles or 1 year.

Read the detailed description

This study includes two phases,the first phase is the dose exploration, 6 subjects were first included at the initial dose to confirm the dose safety. If the toxicity is not tolerated, the dose of the chemotherapeutic agent will be reduced depending on the toxicity(including hematological toxicity and non-hematological toxicity) for further exploration. If it can be tolerated, the recommended dose is determined and expanded on this dose. the second phase is the dose expansion, 4 subjects will be enrolled to further observe the safety and efficacy. The DLT(Dose limited toxicity) observation period is set as the first course of treatment(3 weeks). The end point is that the patient has been taking the drug for 16 cycles or 1 year, or the patient dies or develops intolerable toxicity or confirmed disease recurrence or distant metastasis or withdrawal of informed consent.

Being tested
ZKAB001 5mg/kg, Capecitabine
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZKAB001 5mg/kgDrug

    Also called PD-L1 monoclonal antibody

    ZKAB001 D1 IV 5mg/kg every three weeks,up to 16 cycles or 1 year

  • CapecitabineDrug

    Capecitabine po 1000mg / m2/time, 2 times/d for 2 weeks, followed by 1 week of stopping ,three weeks is a course of treatment with a total of 8 courses

Study groups in NCT04608786
Study groupRoleWhat they receive
Combined the therapy using Capecitabine and PD-L1ExperimentalPD-L1 antibody ZKAB001 D1 5mg/kg every three weeks,up to 16 cycles or 1 year of treatment or the patient has tumor recurrence or metastasis Capecitabine 1000mg / m2/time, 2 times/d for 2 weeks, followed by 1 week of stopping ,three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis
Receives: Drug: ZKAB001 5mg/kg; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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 (6)

  1. AUC(0-t)

    Area under curve 0-t

    Measured: 16 periods or 1 year

  2. Cmax

    Peak concentration

    Measured: 16 periods or 1 year

  3. Tmax

    Peak time

    Measured: 16 periods or 1 year

  4. Disease-free Survival

    Form date of randominzation until the date of the first tumor recurrence/ometastasis or death of the subject due to any reason

    Measured: up to 24 months

  5. Overall survival (OS)

    From date of randomization until the date of death from any cause or the date of last follow-up whichever came first

    Measured: up to 24 months

  6. the number of subjects presenting detectable anti drug antibodies (ADAs)

    To evaluated the number of subjects presenting detectable anti drug antibodies (ADAs)

    Measured: through study completion,an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start1 Feb 2021
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04608786
Sponsor's protocol ID
NTL-LEES-2019-01
Status last verified
Jan 2022
First submitted
22 Oct 2020
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZKAB001 5mg/kg and Capecitabine in people with Biliary Tract Cancer, 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 10 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 11 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 NCT04608786.

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 11 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in