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

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbisko Therapeutics Co, Ltd
• Treatments: Immune Checkpoint Inhibitors

Criteria

Inclusion Criteria:

1. Volunteer to participate in this clinical trial, understand the study procedures, and be able to sign a written informed consent.

2. 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;

3. 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)

4. The ECOG PS (performance status) score is 0-1 point;

5. The estimated survival period of 3 months;

6. 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

7. 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;

Exclusion Criteria:

1. Known allergic to AZD4547 tablets or components; allergic to monoclonal antibody drugs and fusion protein drugs.

2. Patients with imaging progression after previously receiving selective FGFR inhibitors or receiving immune checkpoint inhibitors

3. 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

4. A history of idiopathic pulmonary fibrosis (including pneumonia), drug-related pneumonia, organic pneumonia

5. Subjects requiring systemic treatment with corticosteroids (prednisone or similar drug> 10 mg / day) or other immunosuppressive agents within 14 days prior to enrollment.a)

6. Other malignant tumors requiring treatment were present within 6. 3 years

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.