Clincosm LogoSign in Get a demo

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

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04716634
Collaborator
Hutchison Medipharma Limited (Industry)
90
Enrollment
14
Locations
1
Arm
38.4
Anticipated Duration (Months)
6.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 19, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tislelizumab + Fruquintinib

Participants with one of the tumors will be enrolled: GC,CRC and NSCLC

Drug: Tislelizumab
Tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against PD 1.
Other Names:
  • BGB-A317

    • Drug: Fruquintinib
    Fruquintinib is a potent, oral VEGFR tyrosine kinase inhibitor (TKI)
    Other Names:
  • HMPL-013

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part 1 - Adverse Event (AE) [Up to 28 Days in Part 1]

      Assessed per NCI-CTCAE v5.0

    2. Part 1 - RP2D Of Fruquintinib In Combination With Tislelizumab [Up to 28 Days in Part 1]

    3. Part 2 - Objective Response Rate (ORR) [through study completion, an average of 3 years]

      Assessed per RECIST v1.1

    Secondary Outcome Measures

    1. Part 2 - Progression-Free Survival (PFS) [through study completion, an average of 3 years]

      Assessed per RECIST v1.1

    2. Part 2 - Disease Control Rate (DCR) [through study completion, an average of 3 years]

      Assessed per RECIST v1.1

    3. Part 2 - Clinical Benefit Rate (CBR) [through study completion, an average of 3 years]

      Assessed per RECIST v1.1

    4. Part 2 - Duration Of Response (DOR) [through study completion, an average of 3 years]

    5. Part 2 - Overall Survival (OS) [through study completion, an average of 3 years]

    6. Part 2 - Adverse Event [through study completion, an average of 3 years]

      Assessed per NCI-CTCAE v5.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fujian Provincial Cancer Hospital Fuzhou Fujian China 350014
    2 The First Hospital of Lanzhou University Lanzhou Gansu China 73000
    3 Harbin Medical University Cancer Hospital - Oncology Haerbin Heilongjiang China 150081
    4 Henan Cancer Hospital Zhengzhou Henan China 450008
    5 Shandong Cancer Hospital Jinan Shandong China 250117
    6 Liaocheng People's Hospital Liaocheng Shandong China 252000
    7 Linyi Cancer Hospital Linyi Shandong China 276001
    8 West China Hospital ,Sichuan University Chengdu Sichuan China 610041
    9 Sir Run Run Shaw Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China 310000
    10 Tianjin Medical University Cancer Institute and Hospital Tianjin China 300060
    11 National Cancer Center (NCC) Goyang-si Gyeonggi-do Korea, Republic of 10408
    12 National Cancer Center Gyeonggi-do Korea, Republic of 10408
    13 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of
    14 Asan Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • BeiGene
    • Hutchison Medipharma Limited

    Investigators

    • Study Director: Jian Li, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04716634
    Other Study ID Numbers:
    • BGB-A317-fruquintinib-201
    First Posted:
    Jan 20, 2021
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by BeiGene
    Solid tumors
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jun 30, 2022