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

NCT05775874 | Unknown Phase 2

• 1 other identifier: ABSK091-203
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Safety index

  Part A:Dose limiting toxicity (DLT) incidence

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

• Effectiveness indicators

  Part B: Objective remission rate

  at least 8 weeks

Study Arms (1)

An open evaluation of AZD4547 combined with Tislelizumab in UC patients

OTHER

AZD4547 : 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.

Drug: AZD4547; Drug: Tislelizumab

Interventions

AZD4547 DRUG

Initiation dose: 80mg BID,po.

Also known as: FGFR1/2/3/4 inhibitor

An open evaluation of AZD4547 combined with Tislelizumab in UC patients

Tislelizumab DRUG

Tislelizumab:200mg Q3W

Also known as: PD1 inhibitor

An open evaluation of AZD4547 combined with Tislelizumab in UC patients

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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
• The electrolyte disorders that cannot be corrected and affect serum potassium, blood calcium or blood phosphorus levels.
• \. Unstable or symptomatic CNS transfer
• \. The researchers judge that the subject has factors that significantly affect the absorption of oral drugs.
• Current active infection or fever of unknown origin\> 38.5℃
• \. Previous allograft or stem cell transplantation or organ transplantation.
• \. Use of any live or attenuated vaccine against infectious diseases (e. g., influenza, chickenpox, etc.)
• \. End time of other anti-tumor treatment from first study drug:
• \. Patients with reversible adverse events caused by previous antitumor therapy, not returning to grade CTCAE
• 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.

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

AZD4547; tislelizumab; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Dingwei Ye, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Lu, Director

CONTACT

021-68910052; clinical@abbisko.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: March 20, 2023
• Study Start: September 30, 2022
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

CN (1)