Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Multicenter, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Patients With Selected Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716634
• Other study ID #: BGB-A317-fruquintinib-201
• Secondary ID: CTR20211070
• Status: Completed
• Phase: Phase 2
• Start date: April 19, 2021
• Est. completion date: February 22, 2024

Study information

• Verified date: March 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in participants with advanced or metastatic, unresectable gastric cancer (GC), or colorectal cancer (CRC) or Non-small Cell Lung Cancer (NSCLC). The study will be conducted in 2 parts. Part 1 will be the safety run-in stage to determine dose-limiting toxicity (DLT) and recommended Phase 2 dose (RP2D). Part 2 will assess the preliminary efficacy of tislelizumab in combination with fruquintinib in participants as measured by the overall response rate (ORR) and other efficacy and safety profiles.

Description:

This is an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in patients with advanced or metastatic, unresectable GC, and CRC or NSCLC. The study will be conducted in 2 parts.

Part 1 of the study will be the safety run-in stage which assesses dose-limiting toxicities (DLTs) and RP2D. Part 2 will begin at RP2D. Patients enrolled in Part 1 at RP2D will be counted towards Part 2; up to approximately 30 patients per cohort will be enrolled at RP2D.

The primary outcome measure of the study is ORR as assessed by the investigator per RECIST v1.1. Tislelizumab and fruquintinib will be administered until disease progression, intolerable toxicity, death, withdrawal of consent or until the study terminates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Signed informed consent form (ICF) and able to comply with study requirements.

2. At least 1 measurable lesion as defined by RECIST v1.1.

3. Tumor tissue (archival tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment

4. Eastern Cooperative Oncology Group (ECOG) Performance Status =1

5. Histologically or cytologically confirmed, advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction or colon or rectum, and histologically or cytologically confirmed, locally advanced (Stage IIIB) not amenable to curative surgery or radiotherapy, or metastatic (Stage IV) NSCLC

Key Exclusion Criteria:

1. Has at screening any central nervous system metastasis and/or leptomeningeal disease.

2. Prior therapy targeting CTLA-4, PD-1, PD-L1 or programmed cell death protein ligand-2 (PD-L2) or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

3. Prior treatment with VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab).

4. Received more than 1 line of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction, or more than 2 lines of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of the colon or rectum, or prior systemic therapy for advanced or metastatic NSCLC.

5. Active autoimmune diseases or history of autoimmune diseases that may relapse, or history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• Tislelizumab
Tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against PD 1.
• Fruquintinib
Fruquintinib is a potent, oral VEGFR tyrosine kinase inhibitor (TKI)

Locations

Country	Name	City	State
China	West China Hospital ,Sichuan University	Chengdu	Sichuan
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Harbin Medical University Cancer Hospital - Oncology	Haerbin	Heilongjiang
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Linyi Cancer Hospital	Linyi	Shandong
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	Henan Cancer Hospital	Zhengzhou	Henan
Korea, Republic of	National Cancer Center (NCC)	Goyang-si	Gyeonggi-do
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
BeiGene	Hutchison Medipharma Limited

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 - Adverse Event (AE)	Assessed per NCI-CTCAE v5.0	Up to 28 Days in Part 1
Primary	Part 1 - RP2D Of Fruquintinib In Combination With Tislelizumab		Up to 28 Days in Part 1
Primary	Part 2 - Objective Response Rate (ORR)	Assessed per RECIST v1.1	through study completion, an average of 3 years
Secondary	Part 2 - Progression-Free Survival (PFS)	Assessed per RECIST v1.1	through study completion, an average of 3 years
Secondary	Part 2 - Disease Control Rate (DCR)	Assessed per RECIST v1.1	through study completion, an average of 3 years
Secondary	Part 2 - Clinical Benefit Rate (CBR)	Assessed per RECIST v1.1	through study completion, an average of 3 years
Secondary	Part 2 - Duration Of Response (DOR)		through study completion, an average of 3 years
Secondary	Part 2 - Overall Survival (OS)		through study completion, an average of 3 years
Secondary	Part 2 - Adverse Event	Assessed per NCI-CTCAE v5.0	through study completion, an average of 3 years