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Urothelial CarcinomaPhase 2NCT05775874

A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC

A Phase 2 study testing AZD4547 and Tislelizumab in people with Urothelial Carcinoma, run by Abbisko Therapeutics Co, Ltd 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This trial is an open, phase II clinical study. The study is divided into two parts: A and B, and the part A evaluate the safety and tolerability of AZD4547 combined with Tislelizumab in patients with locally advanced or metastatic urothelial cancer, determine the recommended dose of midoral AZD4547 combined with… Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
AZD4547 and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
30 Sep 2022to 30 Dec 2025
Phase
Phase 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 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in this clinical trial, understand the study procedures, and be able to sign a written informed consent.
  • Age of 25 years old at the time of signing the informed consent (or the age range specifically required by the regulatory agency or ethics), without gender limitation;
  • By histologically confirmed, surgical unresectable local advanced or metastatic urothelial cancer patients, can be accompanied by other histological type differentiation (including adenoid, squamous or other types)
  • The ECOG PS (performance status) score is 0-1 point;
  • The estimated survival period of 3 months;
  • Good organ function level meets the following laboratory examination requirements, and the examination results should be obtained within 14 days before the first administration of the study treatment
  • Fertility female or male subjects must agree to use a medically approved contraceptive measure during the study treatment and within 6 months after the end of the study treatment period; fertile female subjects must have a negative blood β -hCG test within 7 days before the first dose and must be non-lactating;

Who cannot join

  • Known allergic to AZD4547 tablets or components; allergic to monoclonal antibody drugs and fusion protein drugs.
  • Patients with imaging progression after previously receiving selective FGFR inhibitors or receiving immune checkpoint inhibitors
  • Subjects with a history of an active autoimmune disease or a possible recurrence of an autoimmune disease, as judged by the investigator, should be excluded. Patients are admitted for the following diseases: hypothyroidism that can be controlled by hormone replacement therapy only, skin diseases without systemic treatment
  • A history of idiopathic pulmonary fibrosis (including pneumonia), drug-related pneumonia, organic pneumonia
  • Subjects requiring systemic treatment with corticosteroids (prednisone or similar drug> 10 mg / day) or other immunosuppressive agents within 14 days prior to enrollment.a)
  • Other malignant tumors requiring treatment were present within 6. 3 years
Show all 21Show fewer
  • 7 The electrolyte disorders that cannot be corrected and affect serum potassium, blood calcium or blood phosphorus levels.
  • 8. Unstable or symptomatic CNS transfer
  • 9. The researchers judge that the subject has factors that significantly affect the absorption of oral drugs.
  • 10 Current active infection or fever of unknown origin> 38.5℃
  • 11. Previous allograft or stem cell transplantation or organ transplantation.
  • 12. Use of any live or attenuated vaccine against infectious diseases (e. g., influenza, chickenpox, etc.)
  • 13. End time of other anti-tumor treatment from first study drug:
  • 14. Patients with reversible adverse events caused by previous antitumor therapy, not returning to grade CTCAE
  • 15 Patients are using, or are using, the following drugs or foods within 7 days before the first administration of the study treatment: CYP3A4 and CYP2D6 strong inhibitors or inducers.
  • 16. Presence of uncontrolled cardiovascular disease or medical history, including: a) Congestive heart failure
  • 17. Any abnormal corneal or retinal changes that may increase the risk of ocular toxicity during screening, including:
  • 18. Human immunodeficiency virus (HIV) infection (HIV antibody serotest positive) or previously acquired / hereditary immunodeficiency disease
  • 19 Patients with refractory / uncontrolled ascites or pleural effusion. Patients were allowed to use an indwelling catheter.
  • 20 Severe unhealed skin / mucosal ulcers, chronic ulcers of the lower extremities, known gastric ulcers, or incisions are present.
  • 21. Any other medical treatment (e. g., respiratory, metabolic, infectious, immune, congenital, endocrine, or central nervous system diseases), mental or social factors that may sign informed consent, cooperation, participate in clinical studies or affect the interpretation of the research results.

Trial locations and contacts

1 site in 1 country.

Yuan Lu, Director contact

021-68910052

clinical@abbisko.cn

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Dingwei Ye, Professor, 02164175590, dwyeli@163.com

    Dingwei Ye, professor

    Recruiting

Other trials in China

About this study

Official title: A Sigle-arm，Open Label，Multicenter Study of AZD4547 Combination With Tislelizumab for Patients With Metastatic or Locally Advanced Urothelial Carcinoma (mUC) Harboring Fibroblast Growth Factor Receptor Alterations

This trial is an open, phase II clinical study. The study is divided into two parts: A and B, and the part A evaluate the safety and tolerability of AZD4547 combined with Tislelizumab in patients with locally advanced or metastatic urothelial cancer, determine the recommended dose of midoral AZD4547 combined with Tislelizumab in a Chinese patient population. Part B study will evaluate the efficacy of this recommended dose combined with Tislelizumab in patients with locally advanced or metastatic urothelial cancer with FGFR2 / 3 alterations , and will also further evaluate the safety, tolerability, and PK and PD characteristics of AZD4547 in combination with Tislelizumab.

Read the detailed description

Part A of the study In Part A, subjects will receive AZD4547 80mg BID orally for cycles every 21 days and terelizumab 200mg will be an intravenous infusion (IV) 200mg every 3 weeks. Subsequent subjects in Part A should be administered at least 7 days after the first dose of the first subject (sentinel subject). . Tolerability will be assessed based on the incidence of dose-limiting toxicity (DLT) observed in cycle 1 (21 days). Part B; If a DLT event occurs in> 1 of the 6 DLT-evaluable subjects, With the consent of the investigator and the sponsor, An additional combined regimen cohort of six patients with a lower AZD4547 dose (AZD4547 60mg BID + Tislelizumab 200mg Q3W) will be initiated. I A specific dose / regimen of subjects and no more than one subject with DLT events will be selected to confirmation for confirmation for use in the Part B study. After cycle 1, subjects will continue to receive combination therapy in one cycle every 21 days until disease progression, death, loss to follow-up, voluntary withdrawal of informed consent, occurrence of intolerable toxicity, investigator decision to terminate treatment, or the end of the entire study. Safety assessments will be performed in each visit cycle, including the incidence and severity of adverse events (according to CTCAEv5.0) and laboratory abnormalities Study Part B Patients with locally advanced or metastatic urothelial carcinoma harboring FGFR2 / 3 alterations will follow the Simon's optimal two-stage design. It was considered "efficacy evaluable" when tumor assessment results were available at both baseline and after treatment

Being tested
AZD4547, Tislelizumab
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.

  • AZD4547Drug

    Also called FGFR1/2/3/4 inhibitor

    Initiation dose: 80mg BID,po.

  • TislelizumabDrug

    Also called PD1 inhibitor

    Tislelizumab:200mg Q3W

Study groups in NCT05775874
Study groupRoleWhat they receive
An open evaluation of AZD4547 combined with Tislelizumab in UC patientsOtherAZD4547 : Initiation dose 80mg BID,po;Until disease progression, death, loss to follow-up, voluntary withdrawal of informed consent, development of intolerable toxicity, investigator decision to discontinue treatment, or completion of the entire study. Tislelizumab:200mg Q3W, Until disease progression, death, loss to follow-up, voluntary withdrawal of informed consent, development of intolerable toxicity, investigator decision to discontinue treatment, or completion of the entire study.
Receives: Drug: AZD4547; Drug: Tislelizumab

What is being measured

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

  1. Safety index

    Part A:Dose limiting toxicity (DLT) incidence

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. Effectiveness indicators

    Part B: Objective remission rate

    Measured: at least 8 weeks

Timeline

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

  1. First posted20 Mar 2023
  2. Study start30 Sep 2022
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Dec 2025 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05775874
Sponsor's protocol ID
ABSK091-203
Status last verified
Mar 2023
First submitted
8 Oct 2022
Last updated
20 Mar 2023
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 2 study testing AZD4547 and Tislelizumab in people with Urothelial Carcinoma, run by Abbisko Therapeutics Co, Ltd 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 7 inclusion and 21 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 20 Mar 2023. 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 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 Yuan Lu, Director (021-68910052, clinical@abbisko.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety index (time frame: At the end of Cycle 1 (each cycle is 28 days)). 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 NCT05775874.

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 20 Mar 2023.

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