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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04716634
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : June 30, 2022
Sponsor:
Collaborator:
Hutchison Medipharma Limited
Information provided by (Responsible Party):
BeiGene

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
Advanced Solid Tumors Drug: Tislelizumab Drug: Fruquintinib 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 19, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2024

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 Name: BGB-A317

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




Primary Outcome Measures :
  1. Part 1 - Adverse Event (AE) [ Time Frame: Up to 28 Days in Part 1 ]
    Assessed per NCI-CTCAE v5.0

  2. Part 1 - RP2D Of Fruquintinib In Combination With Tislelizumab [ Time Frame: Up to 28 Days in Part 1 ]
  3. Part 2 - Objective Response Rate (ORR) [ Time Frame: through study completion, an average of 3 years ]
    Assessed per RECIST v1.1


Secondary Outcome Measures :
  1. Part 2 - Progression-Free Survival (PFS) [ Time Frame: through study completion, an average of 3 years ]
    Assessed per RECIST v1.1

  2. Part 2 - Disease Control Rate (DCR) [ Time Frame: through study completion, an average of 3 years ]
    Assessed per RECIST v1.1

  3. Part 2 - Clinical Benefit Rate (CBR) [ Time Frame: through study completion, an average of 3 years ]
    Assessed per RECIST v1.1

  4. Part 2 - Duration Of Response (DOR) [ Time Frame: through study completion, an average of 3 years ]
  5. Part 2 - Overall Survival (OS) [ Time Frame: through study completion, an average of 3 years ]
  6. Part 2 - Adverse Event [ Time Frame: through study completion, an average of 3 years ]
    Assessed per NCI-CTCAE v5.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716634


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
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China, Fujian
Fujian Provincial Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350014
China, Gansu
The First Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China, 73000
China, Heilongjiang
Harbin Medical University Cancer Hospital - Oncology Recruiting
Haerbin, Heilongjiang, China, 150081
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
China, Shandong
Shandong Cancer Hospital Recruiting
Jinan, Shandong, China, 250117
Liaocheng People's Hospital Recruiting
Liaocheng, Shandong, China, 252000
Linyi Cancer Hospital Recruiting
Linyi, Shandong, China, 276001
China, Sichuan
West China Hospital ,Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Sir Run Run Shaw Hospital Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310000
China
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, China, 300060
Korea, Republic of
National Cancer Center (NCC) Active, not recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
National Cancer Center Active, not recruiting
Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital Active, not recruiting
Seongnam-si, Korea, Republic of
Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
BeiGene
Hutchison Medipharma Limited
Investigators
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Study Director: Jian Li BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04716634    
Other Study ID Numbers: BGB-A317-fruquintinib-201
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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:
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Neoplasms